Phase II Study of Durvalumab Combined with Chemotherapy and Focused Radiation Therapy for Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for individuals with extensive-stage small cell lung cancer who have not received prior treatment. This phase II trial aims to find out if adding focused ablative radiation therapy to a combination of durvalumab and chemotherapy drugs carboplatin and etoposide can improve how long patients live without their cancer worsening. Durvalumab combined with chemotherapy is already FDA-approved, and this study is testing whether adding radiation can provide additional benefit. Your participation will last about 48 months. Participants will receive up to four 21-day cycles of chemotherapy with carboplatin, etoposide, and durvalumab as part of their treatment plan. Ablative radiation therapy, which targets specific tumor areas with a high dose of radiation, will be given during the second cycle. After these four cycles, patients will continue receiving a fixed dose of durvalumab alone until their cancer progresses, they experience serious side effects, or choose to leave the study. During the study, participants will undergo regular assessments including scans to measure tumor response and monitor side effects. The main outcome measured is progression-free survival over 48 months, along with secondary outcomes like overall survival, adverse event rates, time to next therapy, and new lesion development. Throughout the study, medical teams will closely track health, treatment effects, and safety to understand how well this treatment combination works in extensive-stage small cell lung cancer.

Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)