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OP RSH PRO00042030 ZHANG MK-6070-003 SCREENING/RESCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00042030 - MK-6070-003

Screening (-28 Day to -1 Day)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	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:MK-6070-003_Zhang
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Treatment: Refer to Section 6.6 (***DOSE MODIFICATION***) Management of AEs Associated with MK-6070, I-DXd, atezolizumab, carboplatin, etoposide
Protocol Access Hyperlink:  MK-6070-003_Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Informed consent.
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Physical examination: full exam- perform within 7 days before C1D1
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Weight - Perform within 7 days prior to C1D1. If performed within 3 days prior to C1D1, do not repeat at C1D1. If >=10% change in body weight occurs, weight-based therapy should be readjusted
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, Heart rate, RR, temperature, and SpO2.
Participant to be resting in a sitting position
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent for Additional Research
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Participant Identification Card
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Tobacco Use Assessment
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Medication Review. Review of prior anticancer treatment is required at screening. Concomitant medication review is performed throughout safety followup
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	ECOG Performance Status. To be performed within 7 days of C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1
			Imaging
☑	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	All participants are required to have bone scans to assess for bone lesions during Screening.
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	All participants are required to have bone scans to assess for bone lesions during Screening.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Taken in triplicate at Screening only.
ECGs will be taken while the participant is in a supine or sitting position for 10 min or more
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Taken in triplicate at Screening only.
ECGs will be taken while the participant is in a supine or sitting position for 10 min or more
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Taken in triplicate at Screening only.
ECGs will be taken while the participant is in a supine or sitting position for 10 min or more
			Imaging
◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --		◉	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	All participants are required to have brain scans during Screening.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	FERRITIN LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	T3	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tissue for Biomarkers. Archival (within 6 months of diagnosis) or newly obtained core biopsy of a tumor lesion not previously irradiated. If a sample was obtained during full Screening, an additional sample is not required during Rescreening
					
Rescreening (-28 Day to -1 Day)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Perform within 7 days prior to C1D1. If performed within 3 days prior to C1D1, do not repeat at C1D1. If >=10% change in body weight occurs, weight-based therapy should be readjusted
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Physical examination: full exam- perform within 7 days before C1D1
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, Heart rate, RR, temperature, and SpO2.
Participant to be resting in a sitting position
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent for Additional Research
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Tobacco Use Assessment
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Prior and Concomitant Medication Review. Review of prior anticancer treatment is required at screening. Concomitant medication review is performed throughout safety followup
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	ECOG Performance Status. To be performed within 7 days of C1D1. If performed within 3 days prior to C1D1, the assessments do not have to be repeated at C1D1
			Imaging
☑	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	All participants are required to have bone scans to assess for bone lesions during Screening.
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	All participants are required to have bone scans to assess for bone lesions during Screening.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Taken in triplicate at Screening only.
ECGs will be taken while the participant is in a supine or sitting position for 10 min or more
			Imaging
◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --		◉	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	All participants are required to have brain scans during Screening.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	HBV, HCV, or HIV testing is required at Screening only if there is known history of viral hepatitis or HIV or as mandated by local health authority
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	FERRITIN LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	T3	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tissue for Biomarkers. Archival (within 6 months of diagnosis) or newly obtained core biopsy of a tumor lesion not previously irradiated. If a sample was obtained during full Screening, an additional sample is not required during Rescreening