Protocol Index	

If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RESEARCH PRO00037085 D926XC00001 ARM 1 MAI	

Types:      Research Oncology Treatment
Synonyms:  

Take Home Medication	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Take-Home Medications
  	ondansetron ODT (ZOFRAN-ODT) 8 MG disintegrating tablet	Dose: 8 mg	Route: oral	every 8 hours PRN	Dispense: 30 tablet	Refills: 8	Start: S				  	dexAMETHasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 54 tablet	Refills: 0	Start: S			Instructions:	Take with food ONLY on days 2, 3, and 4 after chemotherapy.		  	dexAMETHasone 0.5 mg/5 mL solution	Dose: 0.5 mg	Route: oral	4 times daily	Dispense: 600 mL	Refills: 8	Start: S			Comments:	Alcohol free if possible.	Instructions:	Start the mouthwash on the first day of treatment; swish for 2 minutes and spit 4 times per day. Do not eat for 1 hour after using the mouthwash.					
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Randomization: Every effort should be made to minimize the time between randomization and starting treatment (ie, within 3 business days of randomization).
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed.  To be performed within 72 hours prior to Day 1 of each cycle.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history: If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Past and current medical conditions: If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: All AEs will be recorded on the AE eCRF page. At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Participant follow-up contact/Participant review for safety: Phone call within 10 days after receiving study intervention (Dato-DXd arms only)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	ePRO training and setup
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	LDH	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed. To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 72 hours prior to starting study intervention, they do not have to be repeated at C1D1 if the participant's condition has not changed
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	ANTI-MULLERIAN HORMONE (AMH)	Interval: --	Occurrences: --	Comments:	Available ONLY at HMH and HMCL
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	(within8 hours prior to dose) . Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 180 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Within 1 hour after end of infusion.
			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.
		  	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 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	(within8 hours prior to dose) . Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Disease assessment (includes physical exam, clinical signs and symptoms)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	(within8 hours prior to dose) . Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Within 1 hour after end of infusion.
			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.
		  	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		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	(within8 hours prior to dose) . Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Disease assessment (includes physical exam, clinical signs and symptoms)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Flush
  	INV-dextrose 5 % flush (TROPION-B03/PRO00037085/JAIN)	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Use with Dato-DXd. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Dato-DXd			Nursing Orders
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Dato-DXd		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Dato-DXd			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	(within8 hours prior to dose) . Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			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.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in dextrose 5% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.	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	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to treatment.			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	When both drugs are administered, infuse Dato-DXd first, then infuse durvalumab,  with at least 1 hour between both infusions to allow for monitoring of infusion-related reactions.
			Chemotherapy
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	o If INV-Dato-DXd infusion is interrupted, total infusion time must not exceed 4.5 hours at room temp. Do not co-administer other drugs through the same infusion line. Protect from light. Post infusion, flush line with D5W per std practice
		  	INV-Dato-DXd (TROPION-B03/Pro00037085/Mai) 6 mg/kg in dextrose 5% 250 mL IVPB	Dose: 6 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag contains Dato-DXd. Administer intravenously unsing 0.22 or 0.2 micron inline filter. Post infusion, flush with D5W only. Stable for 4.5 hours at room temp; 24 hours when refrigerated. 
First dose infuse over 90 (+/- 10) minutes; option: infuse over 30 minutes for subsequent doses. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DATO-DXD 100 MG INJECTION (TROPION-B03/PRO00037085/MAI)	Medications	6 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If Durvalumab infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 120 Minutes	Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	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:    d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Dato -DXd Treatment:  Refer to section 8.3.11.1
Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Durvalumab Treatment:  Refer to Section 8.3.11.2 Protocol Access Hyperlink:   d926xc00001-csp-v1.pdf
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination: To be performed within 72 hours prior to Day 1 of each cycle
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status: To be performed within 72 hours prior to Day 1 of each cycle
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention. On C1D1, blood pressure and pulse will be collected from participants in the Dato-DXd in combination with durvalumab group prior to the beginning of each infusion (measured once from approximately 30 minutes before up to 0 minutes), halfway through infusion (at approximately 45 minutes during infusion of Dato-DXd and approximately 30 minutes during the infusion with durvalumab), and at the end of each infusion of Dato-DXd and durvalumab (approximately 90 [± 10 minutes 
after the start of infusion with Dato-DXd and approximately 60 [± 10] minutes after the start of infusion with durvalumab)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Assessment should be conducted prior to each infusion and at the end of each infusion. Therefore, for participants receiving both Dato-DXd and durvalumab, assessment should be conducted prior to infusion of Dato-DXd, at the end of Dato-DXd infusion/prior to durvalumab infusion, and at the end of durvalumab infusion. On C1D1, participants in the Dato-DXd in combination with durvalumab group will be monitored, and vital signs collected/recorded in the eCRF prior to, during, and after each infusion of study intervention.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Participant-reported symptomatic AEs using PROMIS Fatigue SF 7a, PRO-CTCAE, EORTC IL147 and PGI-TT x
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Mouth and throat symptoms diary; weight reading and urine color change
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	GGT	Interval: --	Occurrences: --	Comments:	To be performed within 72 hours prior to Day 1 of each cycle
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			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.
			Chemotherapy
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	If infusion is interrupted, total infusion time must not exceed 8 hours at room tempt.  Post infusion, flush per standard practice  
		  	INV-Durvalumab (TROPION-B03/Pro00037085/Jain) 1,120 mg in sodium chloride 0.9% 250 mL (4.48 mg/mL) infusion	Dose: 1,120 mg	Route: intravenous	once over 60 Minutes for 1 dose				Instructions:	Prepared bag contains durvalumab. Administer intravenously using 0.22 or 0.2 micron in line filter. Post infusion flush with NS. Stable for 4 hours room temp; 24 hours when refrigerated.
HAZARDOUS - Handle with care. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DURVALUMAB 50 MG/ML INTRAVENOUS SOLN (TROPION-B03/PRO00037085/MAI)	Medications	1,120 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	227.6 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					
EOT	Repeat 1 time	Cycle length: 9 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Disease assessment (includes physical exam, clinical signs and symptoms)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	PGIS: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PGIC: As feasible, site staff should also ensure PRO questionnaires are completed prior to other study procedures, such as collection of laboratory samples and/or discussion of disease recurrence, to further minimize bias.
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	ANTI-MULLERIAN HORMONE (AMH)	Interval: --	Occurrences: --	Comments:	Available ONLY at HMH and HMCL
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.
					
FUP 30	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Targeted physical examination
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy: Subsequent anticancer drug treatment may commence following discontinuation of study intervention, including at disease recurrence.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	within 8 hours prior to dose while on therapy
					
FUP 60	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy: Subsequent anticancer drug treatment may commence following discontinuation of study intervention, including at disease recurrence.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
					
FUP 90	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A clinically indicated.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: At every visit and may be conducted by phone if not tied to a visit.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy: Subsequent anticancer drug treatment may commence following discontinuation of study intervention, including at disease recurrence.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o As clinically indicated. 
o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	o IF ILD/pneumonitis is suspected. 
o HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended).
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Participant-reported symptoms, functioning and HRQoL using PROMIS Physical Function SF 8c, EORTC IL172 and EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
					
Disease recurrence /survival fup	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	HOSPAD (medical resource utilization )
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The blood sample on C1D1 should be taken pre-dose.