Protocol Index	

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OP RESEARCH PRO00037985 / ZHANG J3M-MC-JZQB PRE-SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Pre-Screening	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration. See Safety Parameters-for Toxicity Management and Dose Modification Guidelines.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent for Prescreening
-  For participants without a local laboratory result for PD-L1 expression and/or KRAS G12C mutation status, a prescreening consent is used to provide information to the participant regarding testing for determination of PD-L1 and/or KRAS G12C status in tumor tissue and/or blood. Results for both KRAS G12C mutation and PD-L1 expression must be available to proceed to screening.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Demographics
-  Includes race, ethnicity, gender, and year of birth per local regulations. Demographics only need to be captured once.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Adverse events (AEs)
-  Collect only SAEs at prescreening if deemed reasonably possibly related to study procedures.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Tumor tissue
-  The availability of adequate FFPE tumor tissue for validation of companion diagnostic (CDx) tests for PDL1 and KRAS must be confirmed prior to randomization.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Register visit with IWRS
-  Site to generate patient number in IWRS at prescreening if applicable.