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REPLATINUM: A Phase 3, Controlled, Open-label,Randomized Study of RRx-001 Administered Sequentially with a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Carcinoma
Primary Objective: To compare the Progression Free Survival (PFS) defined as the time from randomization until disease progression or death between the two arms. Secondary Objectives: To compare ORR (overall response rate, RECIST 1.1) between the two arms. To compare overall survival (OS), defined as the time from randomization to death from any cause between switched-over and non-switched-over patients. Tertiary Objectives: To compare the disease control rate (DCR) defined as the sum of complete responses(CR) + partial responses (PR) + stable disease (SD). To correlate change in circulating tumor cells with response. To compare the Time Without Symptoms and Grade 3-4 Hematologic Toxicity (TWiST)and Quality-Adjusted TWiST (Q-TWiST). To compare platinum sensitization rates between the 2 arms. To compare the percentage of treatment delays and dose reductions. The proportion of patients on the RRx-001 arm that developed pseudoprogression. Exploratory Objectives: To correlate density of TGF-beta 1 receptor in tumor with response. To correlate CD-47 expression on circulating tumor cells (CTCs) with response. To correlate SIRP-alpha expression on circulating monocytes with response. To correlate density of tumor associated macrophages with response. To estimate the proportion of patients on the RRx-001 arm that were treated beyond RECIST 1.1 -defined progressive disease. To compare between the two treatment arms the median time to onset of severe myelosuppression, a composite event comprising Grade 3-4 thrombocytopenia, leukopenia and neutropenia. To compare the hematologic toxicity profile of each arm, which includes percent a. Grade 4 neutropenia b. > Grade 3 anemia c. Grade 4 thrombocytopenia d. Febrile neutropenia e. Platelet transfusions. Safety Objective: To evaluate the safety and tolerability assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs,and weight.