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

Types:      Research Oncology Treatment
Synonyms:  

Baseline / Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent
-  The informed consent form must be signed before any protocol-specific tests or procedures are performed. ICF is valid for up to 42 days prior to treatment.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion and Exclusion criteria - See Section 5.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Pathology and Molecular reports describing PDL1 expression and KRAS G12C mutation
-  De-identified local molecular report(s) and pathology report(s) must be submitted prior to randomization. See Section 8.8.
		  	ONC NURSING COMMUNICATION 8	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 9	Interval: --	Occurrences: --	Comments:	Preexisting conditions and medical history, including relevant surgical history
-  All ongoing conditions and relevant past surgical and medical history should be collected.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior treatments for NSCLC
-  Record prior (neo-)adjuvant or consolidation systemic anticancer therapy, surgeries, and/or radiotherapy.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Substance Use: Tobacco
-  Record smoking history of patient.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Concomitant medications
-  Record all medication(s) that are ongoing at time of informed consent and are administered through Short term follow-up.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse events (AEs)
-  See Section 8.3.1 for timing of AE/SAE collection.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Register visit with IWRS
-  Site to generate patient number in IWRS at prescreening if applicable.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	OPTIONAL. To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE, DNA (ABBOTT REALTIME)	Interval: --	Occurrences: --	Comments:	If detected HBsAg or positive anti-Hbc. To be collected once, either on <=28 days or <=14 days relative to C1D1
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	- Serum preferred at screening.
- Collect for women of child-bearing potential only. 
- Done prior to administering study intervention. 
- Additional pregnancy tests should be performed at any time during the trial as required by local regulation, or at the investigator's discretion.
- See Section 10.6.2, Appendix 6.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	- Serum preferred at screening.
- Collect for women of child-bearing potential only. 
- Done prior to administering study intervention. 
- Additional pregnancy tests should be performed at any time during the trial as required by local regulation, or at the investigator's discretion.
- See Section 10.6.2, Appendix 6.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The availability of adequate FFPE tumor tissue for validation of companion diagnostic (CDx) tests for PDL1 and KRAS must be confirmed prior to randomization. See Sections 8.7.1 and 10.3, Appendix 3.
			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Radiologic imaging and measurement of palpable or visible lesions - (per RECIST v1.1) See Section 8.1.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Nuclear Medicine bone scintigraphy, PET scan, or PET component of PET/CT scan
-  For participants with non-measurable bone disease, bone scintigraphy (preferred) or PET scan or PET component of PET/CT scan may be obtained every 24 wk (±7 days) or more often if clinically indicated. Scans may also be obtained as clinically indicated. See Section 8.1.
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
-  Required at baseline for all patients and serially throughout the study for participants with known brain metastases. Imaging should be obtained at same frequency as other radiologic imaging. See Section 8.1.
		  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
-  Required at baseline for all patients and serially throughout the study for participants with known brain metastases. Imaging should be obtained at same frequency as other radiologic imaging. See Section 8.1.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Submit imaging scans to central vendor
-  Scans to be submitted within timely manner. Refer to the imaging manual for details.
				Day -14	Perform every 1 day x1			Research tolerance: -0/+0 days	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Physical examination
-  Excludes pelvic, rectal, and breast exams unless clinically indicated.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG PS Evaluation
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Randomization via IWRS
-  Upon confirmation of eligibility, site to randomize via IWRS. Participants should be treated within 5 days of randomization.
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include heart rate, blood pressure, and oxygen saturation.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Obtain single local ECG.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Confirm that patient has started taking Folic Acid 350-1000mcg PO daily beginning 1-2 weeks prior to the first dose of pemetrexed and continuing until 3 weeks after the last dose of pemetrexed.
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	If hematology or chemistry screening testing is performed LESS THAN or EQUAL 7 days prior to C1D1, repeat testing does not need to occur on C1D1. Should be performed on D1 of every subsequent cycle (for example, C2D1, C3D1). Additional assessments may be obtained at the discretion of the investigator.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Additional coagulation assessments may be obtained at the discretion of the investigator.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Thyroid
- See Section 10.3, Appendix 3.
-  Additional assessments may be obtained at the discretion of the investigator.
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --	Comments:	For Cycles 2-n, collect as clinically indicated.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	OPTIONAL. To be collected once, either on <=28 days or <=14 days relative to C1D1
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE, DNA (ABBOTT REALTIME)	Interval: --	Occurrences: --	Comments:	If detected HBsAg or positive anti-Hbc. To be collected once, either on <=28 days or <=14 days relative to C1D1
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for LY3537982 and Pembrolizumab Treatment
-  Refer to Section 6.5.2 Management of AEs Associated with LY3537982 and Pembrolizumab.
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dispense pembrolizumab
-  Upon confirmation of eligibility, site to dispense study intervention. If site sourcing, please register visit only.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dispense LY3537982/placebo via IWRS
-  Upon confirmation of eligibility, site to dispense study intervention via IWRS.  Refer to Section 6.1.