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OP RSH PRO00038020 ZHANG M23-721 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  LIVIGNO-4, LIVMONIPLIMAB, BUDIGALIMAB , PEMBROLIZUMAB , NSCLC

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	Baseline/Screening Day -28 to Day -1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 14	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:  M23-721-Zhang
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Budigalimab Treatment: Refer to Section 6.5 
Protocol Access HyperlinkM23-721-Zhang                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                     

                                                                                                                                                                                                                                                                                                                                                                                                                                                                 

                                                                                    
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Livmoniplimab treatment : Refer to Section 6.5
Protocol Access HyperlinkM23-721- Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Informed consent
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Eligibility criteria
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	A complete medical history including demographics, history of tobacco, smoking, alcohol, and drug use
will be taken at screening. This detailed history will include a detailed oncology history with date of
diagnosis, method of diagnosis, any surgical procedures and treatments administered (including dates
and type of modality and treatment results such as tumor response and severe AEs), dates and results of
most recent previous tumor assessments, and present signs and symptoms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Alcohol and nicotine use 
Subjects should have no history of clinically significant (per investigator's judgment) drug or alcohol
abuse within the last 6 months.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event assessment.
All serious and nonserious AEs which could be related to study procedures, (e.g., infection at liver biopsy
site, done during screening) will be collected from the time the subject signed the study-specific informed consent until study drug administration
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ALK Translocation and EGFR/ PDL1 Mutation Testing

Results of historical local testing performed for PD-L1, EGFR, ALK, or other genomic aberration (for which a locally approved targeted therapy is available) is required as per eligibility criteria.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Archival Tissue Sample 
Archival tissue sample is required for Stage 1 and is optional for Stage 2. No intervening therapies allowed; sample must be no more than 6 months prior to Cycle 1 Day 1. If no archival sample is available, fresh tissue should be taken; however, only if a fresh biopsy 
does not present a risk to the subject. If a subject does not have archival tissue and fresh tissue retrieval is a risk, subjects can still enroll in the study.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ctDNA blood samples	 
 ± 1 day window from time of tumor assessment scan.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination

A complete physical examination, including height (at Screening only) and weight, will be performed at
the designated study visits as specified in Section 2.1. The physical examination performed on Study
Day 1 will serve as the baseline physical examination for the entire study
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline radiographic tumor assessment (CT or MRI) scans of the chest, abdomen, pelvis and all other known or suspected site of disease must be performed within 28 days prior to first dose of study drug.
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline radiographic tumor assessment (CT or MRI) scans of the chest, abdomen, pelvis and all other known or suspected site of disease must be performed within 28 days prior to first dose of study drug.
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline radiographic tumor assessment (CT or MRI) scans of the chest, abdomen, pelvis and all other known or suspected site of disease must be performed within 28 days prior to first dose of study drug.
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline radiographic tumor assessment (CT or MRI) scans of the chest, abdomen, pelvis and all other known or suspected site of disease must be performed within 28 days prior to first dose of study drug.
			Imaging
◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI with contrast is preferred, if MRI is not possible then CT of head with contrast is acceptable. CT or MRI of the brain with contrast (unless contraindicated) should be performed in all patients at screening
		◉	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --			Imaging
◉	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	If bone metastases are clinically suspected, bone imaging
preferably using FDG-PET-CT should be performed.
				Screening day -3 to day -1	Perform every 1 day x1		Nursing Orders
  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Height (screening only)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital sign determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body
temperature will be obtained at visits as specified in Section 2.1. Blood pressure and pulse rate should
be measured after the subject has been sitting for at least 3 minutes.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECG should be collected prior to missing blood collection and prior to meals when applicable .
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Women of childbearing potential.
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	i
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: Once	Occurrences: --	Comments:	(Cockcroft-Gault GFR estimation)