Study ID: S1400-I
Phase 3 randomized study of nivolumab plus ipilimumab vs. nivolumab for previously treated patients with stage 4 squamous cell lung cancer and no matching biomarker
This treatment trial is for patients who have been diagnosed with stage 4 squamous cell lung cancer and whose tumors do not match one of the currently active drug-biomarker combinations being studied by the researchers. Participants in the S1400-I trial are randomly grouped into two treatment arms.
Those in Arm 1 receive nivolumab, a targeted cancer therapy, intravenously, on day 1 of the trial and ipilimumab, another targeted cancer drug, intravenously on day 1. The courses repeat every 14 days as long as the disease does not progress and no toxicity occurs.
Those in Arm 2 will receive nivolumab intravenously on day 1. The courses repeat every 14 days as long as the disease does not progress and no toxicity occurs.
- No prior T-cell targeting costimulation or immune checkpoint pathways
- No autoimmune or immuno-compromising disease (active, known or suspect)
- No known nivolumab and ipilimumab component allergy
- No systemic corticosteroid taken 14 days prior
- No symptomatic interstitial lung disease or pulmonary toxicity
- Arm 1: nivolumab (3mg/kg IV, day 1 q 14 days) and ipilimumab (1mg/kg IV, day 1 q 42 days)
- Arm 2: nivolumab (3mg/kg IV, day 1 q 14 days)
- Must have been diagnosed with squamous cell lung cancer
- Must not have autoimmune or immuno-compromising disease