Randomized Study Comparing BMS-986489 Atigotatug Nivolumab and Durvalumab as Follow-up Treatment After Chemoradiotherapy for Limited-stage Small-cell Lung Cancer

What this Trial Is About

Researchers are studying limited-stage small-cell lung cancer LS-SCLC to compare the effects and safety of a new combination treatment called BMS-986489, which includes atigotatug and nivolumab, against the standard treatment durvalumab. This phase 2, open-label, randomized trial focuses on participants who have completed chemoradiotherapy without disease progression, aiming to evaluate overall survival and other measures of treatment response. Participants will be randomly assigned to receive either BMS-986489 or durvalumab as consolidation therapy after their initial chemotherapy and radiation. Both treatments are given as fixed-dose intravenous infusions every 28 days for up to two years. Atigotatug is a novel antibody targeting tumor cells, combined with nivolumab, an immune checkpoint inhibitor, while durvalumab is an established immunotherapy. Each study arm plans to enroll up to 125 participants. During the study, participants will undergo regular assessments, including scans and clinical evaluations to monitor tumor response, progression, and overall health. These evaluations occur every 8 weeks initially and then every 12 weeks up to five years after randomization. Safety monitoring for adverse events will continue through treatment and for 100 days after the last dose. The study involves long-term follow-up to understand the treatments impact on survival and disease control.

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)