Protocol Index	

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OP RESEARCH PRO00037521 NCT05609968 MK-3475 SCREENING ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		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
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent - Documented informed consent must be obtained before any protocol-specific screening procedures are performed. Reconsent required to continue study intervention after centrally verified PD.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participant identification card - Update with randomization number at C1D1.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demographic and medical history
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications review - Prior concomitant medications 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 10	Interval: --	Occurrences: --	Comments:	Full physical examination - To be performed within 7 days before start of study intervention
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	12-lead ECG will be obtained at screening, while at rest in the supine position. Abnormal findings are to be evaluated as clinically indicated, including repeated ECGs. Electrocardiograms may be performed at other time points during the study if clinically indicated.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status - Performed within 7 days of C1D1 and at each Cycle Day 1 before administration of treatment
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	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 14	Interval: --	Occurrences: --	Comments:	Measure height
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Predose and as clinically indicated. Measure temperature, respiratory rate, pulse, and blood pressure.
			Imaging
  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Brain scans are required for all participants at screening. For participants with treated brain metastases at baseline, on-study brain scans will be acquired at Week 6 (+7 days) and then as clinically indicated. For participants with no brain metastases at baseline, on-study brain scans are to be acquired as clinically indicated. Participants with baseline brain metastases require brain scans to confirm CR. See Section 8.2.1.1 for other requirements. If MRI is contraindicated or cannot be performed, CT of the head with IV contrast is acceptable. Order CT as appropriate.
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Required at screening for participants with history of bone metastases. See Section 8.2.1.1 for other requirements
		  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor scan - Screening scans are to be captured within 28 days before randomization. All time points are calculated from the date of Randomization
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Absence of EGFR, ALK, and ROS-1 sensitizing genetic aberrations are required for inclusion in the study, except for predominantly squamous histology. Sample must be submitted to Central Laboratory and results obtained for determination of PD-L1 status before randomization. Tissue sample may be tested for Trop-2 IHC if sufficient tissue is available. See Section 8.1.12 and 8.8 for details.
			Labs
  	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
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To confirm WONCBP status if applicable. See Appendix 5.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Required at Screening if mandated by local health authority. Refer to Appendix 2 for details
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	Required at Screening if mandated by local health authority. Refer to Appendix 2 for details
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	Required at Screening if mandated by local health authority. Refer to Appendix 2 for details
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Screening samples to be collected within 10 days before first dose of study intervention (not required to be repeated at C1D1 if Screening sample collected within 72 hours prior).
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Collect screening samples within 10 days before first dose of study intervention
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Collect screening samples within 10 days before first dose of study intervention
		  	T3	Interval: --	Occurrences: --	Comments:	Collect screening samples within 10 days before first dose of study Intervention
		  	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Collect screening samples within 10 days before first dose of study Intervention