NCT03023904

Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-12-29
• Primary completion: 2019-07-30
• Completion: 2020-07-30
• First posted: 2017-01-18
• Last updated: 2018-04-25

Regulatory

• FDA-regulated drug study