Phase II Study of Adebrelimab with Chemotherapy and Low-Dose Radiotherapy for Treating Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of Adebrelimab with chemotherapy and concurrent low-dose radiotherapy LDRT for treating extensive-stage small cell lung cancer SCLC. This Phase II randomized controlled trial aims to understand if adding LDRT to Adebrelimab plus chemotherapy improves treatment outcomes in patients newly diagnosed with this advanced form of lung cancer. The study is sponsored by Sichuan University and focuses on comparing overall survival and other treatment effects between groups. Participants are randomly assigned to one of two groups one receives Adebrelimab combined with chemotherapy and synchronous low-dose radiotherapy, while the other receives Adebrelimab combined with chemotherapy alone. The treatments are given following a set schedule during the first-line and second-line therapy phases. Researchers monitor responses and side effects throughout these treatment periods to assess the combination strategy. During the study, participants will undergo regular assessments including survival tracking, disease progression checks, response evaluations, and safety monitoring for adverse events. The main outcome measured is overall survival up to approximately 36 months after randomization. Secondary outcomes include progression-free survival, disease control rate, response duration, and safety assessments up to 36 months. The total study period extends until December 2028, with continuous monitoring of participant health and treatment effects.

Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)