Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreat-ed, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Scheduled · 2020 until 2029
CA20973L is a phase 3, randomized, open label study to compare nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab or nivolumab alone versus CCRT followed by durvalumab in previously untreated locally advanced non-small cell lung cancer (LA NSCLC). Adding anti-PD-1 treatment concurrently to CCRT is hypothesized to improve anti-tumor activity. Subsequently, combining immunotherapeutic agents with different mechanisms of action in the maintenance period following CCRT may offer the possibility of a synergistic response. PD-1 and CTLA-4 are both co-inhibitory molecules, but evidence suggests that they use distinct mechanisms to limit T cell activation. The current study aims to demonstrate that incorporation of nivolumab to definitive CCRT, followed by nivolumab with/without ipilimumab will be efficacious in participants with newly diagnosed untreated LA NSCLC. Additional objectives of the study include characterization of safety and tolerability, as well as pharmacokinetics, potential predictive biomarkers, and changes in patient-reported outcomes for quality of life assessments. Study Population: Previously untreated locally advanced non-small cell lung cancer (LA NSCLC).