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OP RESEARCH PRO00040000 EF-44 LUNAR-2 SCREENING ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 28 days	Within 28 days	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	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:    EF-44 LUNAR-2_Zhang
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for TT Fields (Novo TTF-200T) Treatment: Refer to Section 5.1.3 Protocol Access Hyperlink:   EF-44 LUNAR-2_Zhang
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	NSCLC History: including diagnosis date, pathological diagnosis, past treatments.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PD-L1 expression
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Tumor tissue: Provision of an archived tumor tissue block (or at least 15 freshly cut unstained slides-however any number of slides would be acceptable) where such samples exist in a quantity sufficient to allow for analysis (refer the Laboratory Manual for details). If an archival sample is not available, provision of a recent (less than or equal to 3 months) tumor biopsy is acceptable, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization.
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. CT/MRI scan of brain and bone scan to be performed as clinically indicated, with the exception of brain MRI scan at screening which is mandatory.
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	CT/MRI scan of brain and bone scan to be performed as clinically indicated, with the exception of brain MRI scan at screening which is mandatory.
				Within 14 days	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording: both prescription and over-the-counter medications taken by the subject throughout the study period, including dose, frequency, indication, start and stop dates.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Full Physical Examination: Full Physical examination includes the following systems: head and neck, eyes, ears, nose, throat, lymph nodes, cardiac, pulmonary, abdominal, extremities, skin, neurological.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			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:	All subjects who are capable of becoming pregnant must take a pregnancy test which is negative within 7 days prior to randomization.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --				Day 0	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Randomization