Spots Global Cancer Trial Database for Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads

Study Description

Brief Summary: This phase II trial studies how well nivolumab works in treating patients with stage IV lung cancer or that has come back after initial treatment who has high mutation loads. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.

Detailed Description: PRIMARY OBJECTIVES: I. To assess the objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. SECONDARY OBJECTIVES: I. To assess the progression-free survival (PFS). II. To assess the overall survival (OS). III. To correlate response and mutation load with PD-L1 status (5% and 1% cutoffs). IV. To assess clinical benefit (responses and stable disease lasting \>= 6 months). V. To assess the response rate in mutation-defined subgroups, including subjects with \>= 25 mutations/mutational burden (MB) and \>= 30 mutations/MB. VI. To correlate the type of mutations with response. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks for up to 2 years (104 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 35 days and then every 3 months for 2 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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