Protocol Index	

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OP RESEARCH PRO00037983 NCT05899608 SRREENING ZHANG	

Types:      Research Oncology Treatment
Synonyms:  SMT112-3003 - HARMONI-3

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent form
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographic data
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Past medical history, drug allergies, smoking, alcohol history
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	History of previous tumors and prior treatments, including prior thoracic radiation
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	PD-L1 22C3 IHC reports and review for known actionable genomic alterations if applicablep
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Tumor imaging evaluation by RECIST v1.1 (including the use of appropriate imaging techniques) and RANO-BM if appropriate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination - Comprehensive exam
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiratory rate, temperature and oxygen saturation
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication/concomitant therapy
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	AE/SAE evaluation
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated) to evaluate for CNS metastases. If baseline CT of the brain is suspicious for brain metastases, MRI scan of the brain is required to confirm or reject CNS metastases.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated) to evaluate for CNS metastases. If baseline CT of the brain is suspicious for brain metastases, MRI scan of the brain is required to confirm or reject CNS metastases.
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated)
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated)
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated)
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Enhanced CT or MRI (if not contraindicated)
		☐	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --		  	CHOLESTEROL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	If the patient shows proteinuria of 2+ or higher on urine dipstick or routine analysis, a 24-hour urine collection should be provided for further analysis
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Women of childbearing age will have a serum pregnancy test before randomization or per region-specific guidance documented in the informed consent