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OP RESEARCH PRO00037521 NCT05609968 MK-3475 ARM 2 ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

Take Home Medications	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: 5	Start: S				  	promethazine (PHENERGAN) 25 MG tablet	Dose: 25 mg	Route: oral	every 6 hours PRN	Dispense: 30 tablet	Refills: 5	Start: S							
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participant identification card - Update with randomization number at C1D1
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Treatment randomization - Dose within 3 days of randomization
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed within 7 days of C1D1and at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 15	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 16	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 17	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 18	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 19	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 20	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 21	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 22	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 23	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 24	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 25	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 26	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 27	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 28	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 29	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 30	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 31	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 32	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 33	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 34	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 35	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - If imaging was obtained within 4 weeks before treatment DC, scan at DC is not mandatory. See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending.
		  	T3	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Collect sample within 72 hours prior). Participants may be dosed in subsequent cycles after C1 while thyroid function tests are pending. Free T3 and free T4 are acceptable.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
Cycle 36	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Section 1.3 Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    MK-3475 D46-02- Zhang
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment :Refer to Section 6.6.1  Protocol Access Hyperlink:   MK-3475 D46-02- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed at each Cycle Day 1 before administration of treatment.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Collect within 3 days before dosing.
			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.
			Biologicals
  	INV-Pembrolizumab (D46-02/Pro00037521/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (D46-02/PRO00037521/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Contact to collect AEs for pembrolizumab arm
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - received within 30 days before the first dose of study intervention through 30 days after the last dose of study intervention (or 90 days if used to treat an SAE) will be recorded.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS clinically indicated
					
EOT	Repeat 1 time	Cycle length: 8 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Full physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Subsequent antineoplastic therapy status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - See Section 8.2.1 for details.
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 are acceptable.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Safety FUP	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	NSCLC-SAQ 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
Administer PROs in the following order: EORTC QLQ-C30, EORTC QLQLC13, NSCLC-SAQ, and EQ-5D-5L. See Section 8.2.2
			Nursing Orders
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential require negative serum test within 72 hours or negative urine test within 24 hours per cycle, before each dose of study intervention. Pregnancy testing will also be conducted at the end of relevant systemic exposure as outlined in Section 8.3.5.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 are acceptable.
		  	T4	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 are acceptable.
					
Efficacy FUP	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Subsequent antineoplastic therapy status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - Follow-up visits may be scheduled to coincide with the imaging schedule. If discontinuation is not due to BICR-verified disease progression, then tumor scans are to continue on the initial treatment period schedule. See Section 8.2.1 for details.See Section 8.2.1 for details.
					
Survival  FUP	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Subsequent antineoplastic therapy status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Continuously  AE/SAE monitoring - Report AEs occurring within 30 days after the last dose of study intervention. Report SAEs occurring within 90 days after the last dose of study intervention, or 30 days after the last dose of study intervention if a new anticancer therapy is initiated, whichever is earlier. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Vital status - Refer to Sections 8.11.4.3 & 8.11.5 Updated vital status may be requested by the Sponsor at any time during the course of the study.