Phase 2 Study of Lurbinectedin with Durvalumab as Maintenance Therapy for Extensive-Stage Small-Cell Lung Cancer After First-Line Chemotherapy and Durvalumab

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining lurbinectedin with durvalumab as a maintenance treatment for participants with extensive-stage small-cell lung cancer ES-SCLC. This study focuses on participants whose disease has not progressed after receiving first-line induction therapy with durvalumab and a platinum plus etoposide chemotherapy regimen. The goal is to assess how well this combination works to control the cancer after initial treatment. Participants will receive lurbinectedin and durvalumab administered by intravenous infusion as maintenance therapy following their initial four cycles of durvalumab and platinum plus etoposide chemotherapy. The study is designed as a single-arm, open-label Phase 2 trial. There is no placebo or comparison group all participants receive the combination treatment. The treatment phase will continue with regular dosing and monitoring to evaluate the effects. During the study, participants will be closely monitored for safety and treatment response. Researchers will assess progression-free survival PFS at 6 months as the primary outcome, along with other measures such as overall response rate, need for dose modifications, and discontinuations over up to 2 years. Blood samples will be collected to measure lurbinectedin levels for up to 3 months. Participants will have scheduled visits for evaluations and safety assessments throughout the study duration, which extends until study completion in 2028.

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC