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OP RSH PRO00038231 ZHANG DS7300-188 / IND144591 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  I-DXD, ADC, SCLC, PRO00038231, DS7300-188, IND144591

Screening	Repeat 1 time	Cycle length: 28 days	-28 day	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:    DS7300-188 - Zhang
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for I-DXd  Treatment : Refer to Section 6.5  Protocol Access Hyperlink:   DS7300-188 - Zhang 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Informed consent

Obtain signed main ICF prior to performing any
study procedures. See Section 8.1.1
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Eligibility assessment
See Section 8.1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Randomization. 

Randomization will be performed upon completion
of screening procedures. See Section 6.3. A maximum of 5 calendar days will be allowed between randomization and the first dose of study drug.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam including weight.
Within 7 days before Cycle 1 Day 1. If performed within 3 days prior to Cycle 1 Day 1, the assessments do not have to be repeated at Cycle 1 Day 1.
See Section 8.4.4.1.
			Nursing Orders
  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --	Comments:	height (screening only).

See Section 8.4.4.1.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs and SpO2 should be collected before infusion. Within 7 days before Cycle 1 Day 1. If performed within 3 days prior to Cycle 1 Day 1, the assessments do not have to be repeated at Cycle 1Day 1. See Section 8.4.4.2.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ophthalmologic assessments

An eye examination performed by an ophthalmologist or optometrist includes a visual
acuity test, slit lamp examination, tonometry, and fundoscopy as per investigator judgment. An eye
examination will be done at screening (<=28 days prior to randomization), EOT (within 40 days [+7]
after last dose of study drug), and as clinically indicated. See Section 8.4.4.6.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG PS

Within 7 days before Cycle 1 Day 1. If performed within 3 days prior to Cycle 1 Day 1, the assessments do not have to be repeated at Cycle 1 Day 1.
See Section 8.4.4.5
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	Note: The same test must be used for the subject throughout the study.
If ECHO/MUGA scan is performed as part of standard of care within 14 days before signed
consent, results could be considered to assess the subject's eligibility
		  	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Note: The same test must be used for the subject throughout the study.
If ECHO/MUGA scan is performed as part of standard of care within 14 days before signed
consent, results could be considered to assess the subject's eligibility
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be taken while the subject is in a supine/semi-recumbent position for 5 minutes or more. ECGs will be taken in triplicate at Screening only, and single ECGs thereafter every 4 cycles predose (eg, Cycle 1 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, etc), at EOT, and as clinically indicated during the Treatment Period. If ECG is abnormal, follow institutional guidelines. Single ECGs will be performed unless a clinically significant abnormality is noted by the investigator, in which case they should be done in triplicate.
See Section 8.4.4.3.
			Imaging
  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	MRI/CT of the brain is mandatory for all subjects at baseline (within 28 days before randomization) and at the EOT Visit (if not performed within the previous 4 weeks) and if brain metastases are present at baseline as per investigator assessment, every 6 weeks (±7 days) until 48 weeks from randomization and every 12 weeks (±7 days) thereafter, until disease progression is confirmed by the investigator and BICR (irrespective of start of new anticancer therapy), death, loss to follow-up, or withdrawal of consent to study procedures, whichever occurs first. Otherwise, brain imaging is required whenever disease progression or brain metastases are suspected. Brain imaging is also required at the time of confirmation of response for subjects who have brain metastases. Contrast enhanced brain MRI is preferred over contrast enhanced head CT.
		  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	MRI/CT of the brain is mandatory for all subjects at baseline (within 28 days before randomization) and at the EOT Visit (if not performed within the previous 4 weeks) and if brain metastases are present at baseline as per investigator assessment, every 6 weeks (±7 days) until 48 weeks from randomization and every 12 weeks (±7 days) thereafter, until disease progression is confirmed by the investigator and BICR (irrespective of start of new anticancer therapy), death, loss to follow-up, or withdrawal of consent to study procedures, whichever occurs first. Otherwise, brain imaging is required whenever disease progression or brain metastases are suspected. Brain imaging is also required at the time of confirmation of response for subjects who have brain metastases. Contrast enhanced brain MRI is preferred over contrast enhanced head CT.
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Evaluations based on RECIST v1.1. Imaging must include CT or MRI of chest, abdomen, pelvis, and any other sites of suspected disease.
A previous tumor assessment scan performed according to standard of care after progression on the previous treatment can be used if performed within 28 days of C1D1, regardless of date signed informed consent. Collect the 2 most recent radiographic tumor assessments obtained prior to screening, if available, for g-score calculation. If more than 2 scans are available, sites are encouraged to provide up to 5 prior tumor assessments. Assessments should be entered based on the target and non-target lesions selected at Baseline.
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Samples shipped to the central laboratory. Newly obtained pretreatment or archival tumor tissue is required to be of sufficient quantity and of
adequate tumor tissue content (as defined in the Laboratory Manual). A tumor biopsy is required for all subjects and to be provided as either of the following:
·If medically feasible, a newly obtained pretreatment tumor biopsy from at least 1 lesion amenable to core biopsy
·If the tumor is inaccessible or the subject is medically unfit for collection of the pretreatment tumor biopsy, archival tumor tissue collected from a biopsy performed within 6 months of consent and performed after treatment with their most recent anticancer therapy regimen
If subjects who undergo a newly obtained pretreatment biopsy also have an archival tumor tissue sample available, it is recommended to
submit both samples to the central laboratory if consent is obtained.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory assessment; see Table 10.1 for the list of analytes. Screening data may be used as C1D1 predose data if obtained within 3 days before administration of I-DXd or comparator. See Section 8.4.3.
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local laboratory assessment; see Table 10.1 for the list of analytes. Screening data may be used as C1D1 predose data if obtained within 3 days before administration of I-DXd or comparator. See Section 8.4.3.
		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.

Local laboratory assessment; see Table 10.1 for the list of analytes. Within 7 days before C1D1 Coagulation tests will be performed at baseline and thereafter as clinically indicated. See Section 8.4.3
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
Local laboratory assessment; see Table 10.1 for the list of analytes. Within 7 days before C1D1 Coagulation tests will be performed at baseline and thereafter as clinically indicated. See Section 8.4.3
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 3 days before randomization for all female subjects of childbearing potential and thereafter within 3 days before infusion at each cycle (urine dipstick or serum), at the EOT Visit (urine dipstick or serum), and at the 40D-FU Visit (urine dipstick or serum) A positive urine pregnancy test result must immediately be confirmed using a serum HCG test. Screening data may be used as C1D1 predose data
if obtained within 3 days before administration of study drug. See Section 8.4.2
		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
Local laboratory assessment; see Table 10.1 for the list of analytes. Within 7 days before C1D1 See Section 8.4.3
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	As required by local regulations or IRB/EC. See Section 8.1.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
See Section 8.1.
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE, DNA (ABBOTT REALTIME)	Interval: --	Occurrences: --	Comments:	If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
See Section 8.1.
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	If hepatitis serology is performed within 14 days before signed consent, results could be considered to assess the subject's eligibility.
See Section 8.1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Only AEs related to protocol-specified procedure or intervention or any SAE should be reported after subject provides documented main informed consent but before first dose of study drug. All AEs, SAEs, and other reportable safety events that occur from the time of first dose through 47 days after last dose of the study drug, or 30 days after last dose if the subject initiates new anticancer therapy, whichever is earlier, should be recorded in the Adverse Events eCRF page. After that, only SAEs considered to be related to the study drug by the investigators should be reported.
See Section 8.4.1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications/nondrug therapy

Only record concomitant medications and transfusions used to treat the SAEs that are considered related to study drug by the investigator
during this period. Include all anti-SCLC treatments taken since the EOT Visit. See Section 6.6.