Phase IbII Study of Ipilimumab, Nivolumab, and Nogapendekin Alfa Inbakicept N-803 for First Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a combination treatment using an anti-PD-1 antibody nivolumab, an anti-CTLA-4 antibody ipilimumab, and nogapendekin alfa inbakicept N-803 in patients with stage IV or recurrent non-small cell lung cancer NSCLC. This phase IbII, single-center study aims to see if adding nogapendekin alfa inbakicept to nivolumab and ipilimumab improves the clinical activity of these drugs in treating advanced NSCLC. Participants receive nivolumab intravenously on Days 1 and 22 and ipilimumab intravenously on Day 1 during cycles that last 42 days each. Nogapendekin alfa inbakicept is given subcutaneously on Days 1 and 22 of each cycle for the first four cycles. After four cycles, ipilimumab is stopped, but patients continue nivolumab and nogapendekin alfa inbakicept on the same schedule for up to two years. This treatment plan is tested across phase Ib dose levels and a phase II group. During the study, researchers monitor participants closely for progression-free survival and dose-limiting toxicities, especially in the early phase. Safety assessments include tracking adverse events up to 100 days after treatment ends. Other important measures include disease control rate, duration and objective response rates, immune-related responses, and overall survival. The study may last up to four years from the start of treatment, with follow-up to assess long-term outcomes and safety.

First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer