This phase II pilot trial studies how well gemcitabine and nivolumab work in treating patients with small cell lung cancer that has spread to other parts of the body (advanced) 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving second-line gemcitabine and nivolumab may work better in treating patients with small cell lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03662074.
PRIMARY OBJECTIVE:
I. To compare response rate (RR) of gemcitabine hydrochloride (gemcitabine) plus 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, treatment tolerability, and health-related quality of life using self-reported items from the National Cancer Institute (NCI) Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and Functional Assessment of Chronic Illness Therapy (FACIT).
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, 6-10 weeks, and every 8 weeks thereafter.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorThomas William Lycan
