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OP RSH PRO00042503 GUAN DS7300-202 ARM :EXPERIMENTAL  I -DXD	

Types:      Research Oncology Treatment
Synonyms:  SCREENING

Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	Verify Hep B panel status prior to cycle. Date *** of panel. Result positive/negative/pending/unknown:22867

The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc), and hepatitis B antibody (anti-HBs).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Ensure Hepatitis B panel obtained if not collected prior to C1D1. Do NOT hold therapy to wait for results. 

The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total Hepatitis B core antibody (anti-HBc), and Hepatitis B antibody (anti-HBs).
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood Sample for ctDNA. Samples will be collected within 3 days before infusion.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma Sample Collection. Samples will be collected within 3 days before infusion.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PBMC Sample Collection
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 2	Perform every 1 day x1			Research tolerance: -0/+0 days	Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
				Day 4	Perform every 1 day x1			Research tolerance: -0/+0 days	Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
Collect Day 22 sample if treatment planned at Cycle 2 Day 1 is interrupted or will be delayed
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood Sample for ctDNA. Samples will be collected within 3 days before infusion.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Full PK Sampling (full PK subset only). Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to the PK
sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.1. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sparse PK Sampling. Only for subjects receiving I-DXd. If time points of
procedures coincide with blood sampling, ECGs and vital signs should be taken immediately prior to PK sampling time.
1 Collect blood samples according to the schedule outlined in Table 8.2. In addition, if feasible, a blood sample should be collected for PK analysis as soon as possible when a subject is suspected of having ILD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment (EOT)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   DS7300-202_Guan
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for I-DXd Treatment: Refer to Section 6.6
Protocol Access Hyperlink:  DS7300-202_Guan[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	EORTC IL46. Within 3 days before infusion, given prior to any other assessments. Assessment can be done remotely with the use of a personal/provisioned electronic device
			Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Local measurement. ECGs will be taken while the subject is in a supine/ semirecumbent position for 5 minutes or more. ECGs will be taken in triplicate at SCR only and single ECG thereafter. Single ECG will be performed prior to the dosing every 4 cycles, EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow the institutional guidelines. Single ECG will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in
triplicate.
1. Every 4 cycles predose starting at C5D1 (eg, C5D1,C9D1, etc), EOT, and as clinically indicated during the Treatment Period.
			Imaging
◉	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	Use the same test for a subject throughout the study.Performed at SCR, EOT, and as clinically indicated
If the test is performed as part of standard of care within 14 days of signed consent, results could be considered to assess the subject's eligibility.
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Use the same test for a subject throughout the study.Performed at SCR, EOT, and as clinically indicated
If the test is performed as part of standard of care within 14 days of signed consent, results could be considered to assess the subject's eligibility.
			Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Subsequent Anticancer Treatment. Include all anticancer treatments for ESCC taken
since the EOT Visit.
			Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Ophthalmologic Assessments.  Includes visual acuity testing, slit lamp examination,
tonometry, and fundoscopy. Performed at SCR, EOT, and as clinically indicated
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Newly Obtained Tumor Biopsy. An optional newly obtained core needle biopsy may be
collected at the EOT.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood Sample for ctDNA. Samples will be collected within 3 days before infusion.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma Sample Collection. Samples will be collected within 3 days before infusion.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PBMC Sample Collection
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if AST or ALT GREATER than 3 and up to 5x Upper Normal Limit
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o Total Bilirubin GREATER than 3x ULN
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S				  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow push 30 minutes prior to chemotherapy		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy			Pre-Medications
☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes				Chemotherapy
  	INV-IFINATAMAB DERUXTECAN (I-DXD) (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN) 12 mg/kg in dextrose 5% 0.9 mL chemo IVPB	Dose: 12 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains I-DXd in D5W.  Infuse over 90 minutes (+/- 10 min) through 0.2-micron inline filter. Subsequent infusions may be administered over 30 min (+/-5 min) if no reaction. Protect from light. FLUSH WITH D5W ONLY. Not compatible with NS. Bag stable 4 hrs at room temp or 24 hrs refrigerated. Initial dose: 90 (±10)-minute infusion. Subsequent doses (if no IRR at first dose): 30 (±5)-minute infusion 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IFINATAMAB DERUXTECAN (I-DXD) 100 MG INTRAVENOUS SOLN (IDEATE-ESOPHAGEAL01/PRO00042503/GUAN)	Medications	12 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	0.9 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
40 Day Follow Up: 40 days follow up after last dose	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
EORTC OES18
EQ-5D-5L
PGI-S 
Within 3 days before infusion, given prior to any other assessments.
Questionnaires at baseline must be completed by subjects before they know the treatment they have been assigned.
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	PGI-C. Within 3 days before infusion, given prior to any other assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Healthcare Resource Utilization. Assess if any non-study related hospital admissions
and visits have occurred. Before infusion
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Examination. A complete physical examination should be performed at SCR. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed.
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG PS. 1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to
be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Subsequent Anticancer Treatment. Include all anticancer treatments for ESCC taken
since the EOT Visit.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Taken approximately 5 minutes prior to ECG measurements. Includes blood pressure, heart rate, respiratory rate, temperature, and SpO2 (by pulse oximetry).
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Measure before infusion
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Bilirubin (direct/indirect, if available). Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LDH	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	GGT	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including optional CK-MB. If clinically indicated.Local laboratory testing 
1 .Within 7 days prior to C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1.
2. Must be performed within 3 days before infusion
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
☑	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Pregnancy Test. Local laboratory testing.
For POCBP, highly sensitive urine or serum pregnancy
testing, as required by local regulations, is required at the timepoints indicated. Note that any positive or equivocal (eg, ambiguous) urine test result must be confirmed by a serum test. See Section 10.3.5.3 for further details.
1 .Negative serum test within 72h or urine test within 24h of dosing is required.
2. Testing (urine) will be performed at home following the EOT visit on a monthly basis until 8 months from last dose of study treatment. The 40D-FU Visit testing is not required if a pregnancy testing is performed approximately 1 month after the EOT Visit
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunogenicity Blood Sample (ADA/NAb). Only for subjects receiving I-DXd.
1. Within 8 hours before infusion.
2. C4D1, C5D1, and every 2 cycles thereafter.
					
Long Term Follow Up (LTFU) : Every 3 Months (Q3M)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Subsequent Anticancer Treatment. Include all anticancer treatments for ESCC taken
since the EOT Visit.
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Only AEs related to a protocol-specified procedure
or intervention or any SAE should be reported after the
subject provides documented main informed consent, but before the first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after the last dose of study drug or 30 days after the last dose if the subject initiates new anticancer treatment, whichever is earlier, should be recorded in the Adverse
Events eCRF page.
1 .Only SAEs that are considered related to the study drug by the investigators should be reported.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Therapies.  Includes medications, prophylactic therapies
(including premedication), nondrug therapies (including transfusions), surgery, and CT and chemoradiotherapy or radiotherapy.
1. All therapies received by subjects during the SCR Period prior to randomization and stopped prior to the first dose of study drug will be recorded as prior medications.
2. After the 40D-FU Visit, only therapies used to treat SAEs that are considered related to the study drug by the investigator must be reported.
			Labs
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Coagulation tests will be performed at baseline and as clinically indicated thereafter 
1 .Within 7 days prior to C1D1.prothrombin time - international normalized ratio partial thromboplastin time, OR activated partial thromboplastin time
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Local laboratory testing.
1 .Urinalysis tests will be performed at baseline and thereafter as clinically indicated during the Treatment Period.
2 .Within 7 days prior to C1D1
glucose
pH
protein
blood
microscopy assessment (if clinically indicated)
specific gravity (if clinically indicated)
			Imaging
☑	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must
include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease. CT/MRI of the brain will be performed for all subjects at baseline if clinically indicated (within 28 days from randomization date), and if brain metastases are present at baseline as per investigator's assessment, every 6 weeks (±7 days) in the first 48 weeks, and every 12 weeks (±7 days)
hereafter. See Section 8.3 for further details.
1. Within 28 days prior to randomization date.
2. Collect the 2 most recent radiographic tumor assessments obtained most recently prior to SCR, if available, for g-score calculation. If >2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Tumor measurements before the study baseline will be collected based on the historical lesions selected at the earliest time point identified for data collection.
3. Every 6 weeks (±7 days) from randomization for the first 48 weeks then every 12 weeks (±7 days) thereafter.
4. Collect 1 additional set of scans after the investigator determined PD, preferably the next scheduled assessment per protocol
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT CHEST W CONTRAST ABDOMEN W WO CONTRAST PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Survival FU