Protocol Index	

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OP PRO00040430 SMT112-3007 SCREENING ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

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:	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 :   SMT112-3007_Zhang
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Study Drug Toxicity Management and Dose Adjustment for SMT112-307 Treatment: Refer to Section 5.4. Management of AEs Associated with Ivonescimab/Pembrolizumab
Protocol Access Hyperlink:  SMT112-3007_Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed consent form/assignment of SID number: 
The results of the tests and examinations at the site within one week prior to obtaining informed consent (and within 28 days prior to the first dose) can be used for screening evaluation without the need for repeating such tests.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Demographic data
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Past medical history, drug allergies, smoking, alcohol history
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	History of previous tumors and prior treatments, including prior thoracic radiation
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	PD-L1 IHC results
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Review for known actionable genomic alterations if applicable
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Tumor imaging evaluation by RECIST v1.1 (including the use of appropriate imaging techniques)
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Physical examination/weight
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration, temperature
		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant medication/concomitant therapy
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	AE/SAE evaluation
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Provide unstained slides
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if appropriate. Please order.
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if appropriate. Please order.
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or PET if appropriate. Please order.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	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 CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --