Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone. SECONDARY OBJECTIVES: I. To compare median overall survival (OS) of G+N to historical controls treated with nivolumab alone. II. To co...

PRIMARY OBJECTIVES: I. To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone. SECONDARY OBJECTIVES: I. To compare median overall survival (OS) of G+N to historical controls treated with nivolumab alone. II. To compare median progression-free survival (PFS) of G+N to historical controls treated with nivolumab alone. III. To evaluate for tolerability of G+N at each treatment cycle and then every 8 weeks after treatment is completed. EXPLORATORY OBJECTIVES: I. To correlate immunophenotypic changes among lymphocytes (quantitative measurements of CD4 and CD8 T-cells) with radiographic response and overall survival before treatment, after treatment and between 8-12 weeks after treatment. II. Among those patients with tumor mutation burden (TMB) status available, to describe the association between TMB (low, medium, or high) and RR, OS, and PFS. III. Assess the patient perspective of symptomatic adverse events using self-reported items from the National Cancer Institute (NCI) Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). OUTLINE: Participants receive gemcitabine intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days, 6-10 weeks, and every 8 weeks thereafter.

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