At a glance
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A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)
In Brief
A Phase 3 clinical trial evaluating Ipilimumab, Laboratory Biomarker Analysis, and 3 other interventions for Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7. Active but no longer recruiting, targeting 275 participants across 1,207 sites in 2 countries.
Signals
Detailed Summary
This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.
Study Details
Timeline
Arms & Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given IV
Ancillary studies
Ancillary studies