ROSETTA Lung-201 A Randomized, Open-label Phase 3 Study Comparing Pumitamig to Durvalumab in Participants With Unresectable Stage III NSCLC After Platinum-based Concurrent Chemoradiation Therapy

What this Trial Is About

Researchers are evaluating Pumitamig compared to Durvalumab in people with unresectable stage III non-small cell lung cancer NSCLC who have completed platinum-based concurrent chemoradiation therapy without disease progression. This phase 3, randomized study aims to compare these treatments in participants with good performance status after prior therapy. The trial is sponsored by Bristol-Myers Squibb and focuses on progression-free survival as the main outcome. Participants will receive either Pumitamig or Durvalumab at specified doses on certain days as part of the study treatment. The study is open-label, meaning both the researchers and participants know which treatment is given. Treatment will follow completion of at least two cycles of platinum-based chemoradiation with a radiation dose of at least 54 Gy and no disease progression after that therapy. Throughout the study, participants will be regularly monitored with scans and assessed for progression-free survival by blinded independent central review using standard criteria. Other outcomes include overall survival, objective response, disease control rate, and duration of response, observed for up to approximately nine years. Safety and disease status will be closely followed to evaluate the treatments over time.

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)