NCT03662074

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

Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II pilot trial studies how well gemcitabine and nivolumab work in treating participants with small cell lung cancer that has spread to other parts of the body after other treatments have failed. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving second-line gemcitabine and nivolumab may work better in treating participants with small cell lung cancer.

Detailed 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 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.

Conditions

• Small Cell Lung Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Gemcitabine	Given IV
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2018-11-07
• Primary completion: 2020-10-07
• Completion: 2022-02-03
• First posted: 2018-09-07
• Last updated: 2023-08-02
• Results posted: 2021-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study