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OP RSH PRO00041272 ZHANG J3M-MC-JZQH PRESCREENING AND SCREENING	

Types:      Research Oncology Treatment
Synonyms:  LUNG (NON SMALL CELL) [10034], PRO00041272, JUNG J3M-MC-JZQH

PRE- Screening	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Nursing Communications:The pre-screening visit is optional , A patient with resectable, resected, or locally advanced NSCLC may enter pre-screening prior to completion of curative therapy.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink: J3M-MC-JZQH_Zhang
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for OLOMORASIB Treatment: Refer to Section 6.6[AR1] 
Protocol Access Hyperlink:   J3M-MC-JZQH_Zhang
					
Baseline /Screening (Up to 28 days)	Repeat 2 times	Cycle length: 28 days	Up to 28 days	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 35	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 before treatment.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria. See Section 5.
		  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Pathology and molecular
reports describing PD-L1
expression and KRAS G12C
mutation status	 	De-identified local molecular report(s)
and pathology report(s) must be
submitted before randomization.
See Section 8.7.3.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Demographics. Includes race, ethnic origin, gender, and year of birth per local regulations. Collect demographics only once.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Preexisting conditions and medical history, including relevant surgical history. Collect all ongoing conditions and relevant past surgical and medical history.
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Prior treatments for NSCLC.Record prior neoadjuvant or adjuvant anticancer therapies or surgeries.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Substance use tobacco and alcohol. Record smoking history and alcohol consumption.
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Concomitant medications.Record all medication(s) that are ongoing at the time of informed consent and are administered through short-term follow-up.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Adverse events (AEs)	. Collect continuously at every visit and as clinically indicated. See Section 8.3.1. for timing of AE/SAE collection.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Physical examination.	Excludes pelvic, rectal, and breast exams unless clinically indicated.
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	ECOG PS evaluation
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Submit imaging scans to central vendor. Submit all scans in timely manner. Refer to the imaging manual for details. For patients who are not eligible for the study, no need to submit imaging to the central vendor
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Register visit with IWRS
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Weight - If the screening exam is performed <=7 days prior to C1D1, repeat examination is not required on C1D1
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Single, local
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST	Interval: --	Occurrences: --	Comments:	Year 1: Collect from first dose every 12 weeks (±14 days).Years 2-3: Collect every 12 weeks (±14 days).
Years 4-5: Collect every 24 weeks (±4 weeks).After Year 5: Collect yearly with low dose CT chest scan (or per local standard
of care), until disease recurrence, death,lost to follow up, withdrawal of consent,or study completion, whichever occurs first.
Frequency is the same for participants who discontinue treatment due to reasons other than disease recurrence.See Section 8.1.
		☑	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Year 1: Collect from first dose every 24 weeks (±14 days).Years 2-3: Collect every 24 weeks (±14 days).
Years 4-5: Collect every 24 weeks (±4 weeks), until disease recurrence, death,lost to follow up, withdrawal of consent, or study completion, whichever occurs first. Frequency is the same for participants who discontinue treatment due to reasons
other than disease recurrence. See Section 8.1.MRI is strongly preferred for brain imaging. If MRI contrast is contraindicated, then MRI without contrast or CT w/wo contrast is acceptable.
		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Year 1: Collect from first dose every 24 weeks (±14 days).
Years 2-3: Collect every 24 weeks (±14 days).
Years 4-5: Collect every 24 weeks (±4 weeks), until disease recurrence, death,
lost to follow up, withdrawal of consent, or study completion, whichever occurs first.
Frequency is the same for participants who discontinue treatment due to reasons
other than disease recurrence. See Section 8.1
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Includes HBsAg and anti-HBc at a minimum. Anti-HBs is optional.
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	Includes HBsAg and anti-HBc at a minimum. Anti-HBs is optional.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	Includes HBsAg and anti-HBc at a minimum. Anti-HBs is optional.
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE, DNA (ABBOTT REALTIME)	Interval: --	Occurrences: --	Comments:	Individuals who have detectable HBsAg or positive anti-HBc must be tested for quantitative HBV DNA by PCR. See Section 8.2.7 for details on monitoring and treatment.
		  	URINALYSIS	Interval: --	Occurrences: --	Comments:	Collect at screening and then as clinically
indicated. Specific gravity ,pH ,Protein ,Glucose
Ketones, Bilirubin
Urobilinogen
Blood
Nitrite
Urine leukocyte esterase ,Microscopic examination of sediment
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Collect for individuals of child-bearing potential. Serum sample recommended at screening
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Archival tumor sample.Screening: FFPE tumor sample for retrospective central laboratory evaluation of PD-L1 and KRAS, and exploratory biomarker assessments. See Section 8.7.
				LESS than or Equal than 14 days	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Participant randomization occurs after confirmation of eligibility. Participants should be treated within 5 days of randomization.
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Dispense olomorasib/placebo Via IWRS Less than or Equal to 14 days. If site sourcing, register visit only[AR1] .
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Dispense SOC drug.See Section 6.1. for details.
			Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	If the screening testing is performed <=7 days prior to C1D1, repeat testing is not required on C1D1.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If the screening testing is performed <=7 days prior to C1D1, repeat testing is not required on C1D1
Hemoglobin, Hematocrit, Erythrocyte count (RBCs - red blood cells), Leukocytes (WBCs - white blood cells), Differential, Percent and/or Absolute Count of Neutrophils, Lymphocytes Monocytes Eosinophils
Basophils, Platelets
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --