Tignamar

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.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced non-small cell lung cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. This Phase 3, randomized, double-blind study aims to compare these two drugs as first-line treatments for locally advanced or metastatic NSCLC. The study is sponsored by Bristol-Myers Squibb and focuses on key outcomes like progression-free survival and overall survival. Participants will be randomly assigned to receive either Pumitamig or Pembrolizumab, both given at specified doses on scheduled days. The study includes two arms: one evaluating Pumitamig as the experimental treatment and the other Pembrolizumab as the active comparator. Treatment will continue with regular monitoring according to the study design. During the trial, participants will undergo assessments including imaging to measure tumor response based on RECIST v1.1 criteria, symptom evaluations using the NSCLC-SAQ questionnaire, and other clinical evaluations. The primary outcomes are progression-free survival by blinded review over approximately 3 years and overall survival up to about 5 years. Secondary outcomes include response rates, duration of response, disease control, time to response, and symptom worsening. Participants' health and safety will be closely monitored throughout the study period, which starts in March 2026 and ends in October 2031.