Phase 1b Study of Iadademstat and Atezolizumab With Radiation Therapy in Adults With Extensive Stage Small Cell Lung Cancer After Platinum-Based Chemotherapy

What this Trial Is About

Researchers are investigating a treatment approach for participants with extensive stage small cell lung cancer ES-SCLC who have residual, progressive, or recurrent disease after initial platinum-based chemotherapy, with or without immune checkpoint inhibitor therapy. This phase 1b study aims to evaluate the safety, tolerability, and effectiveness of combining iadademstat with atezolizumab and stereotactic body radiation therapy SBRT, followed by maintenance therapy using iadademstat and atezolizumab. Participants will begin treatment with iadademstat taken orally once a week, starting at a dose of 600 micrograms, with adjustments guided by a specific dose-finding method. Atezolizumab will be given intravenously at a fixed dose every 28 days until side effects or loss of clinical benefit occur. SBRT will be delivered after starting the drug treatments, ideally between days 8 and 15 of the first treatment cycle, with possible delays for dose adjustments. The study will continue dose finding until a set number of participants are treated or a decision is made to stay at the current dose. Throughout the study, participants will be closely monitored for side effects and treatment responses, including tumor control and overall survival, with assessments occurring during each 28-day cycle and follow-up visits. Researchers will also collect blood samples and perform tumor biopsies before treatment and after SBRT to explore biomarkers. The study includes thorough safety checks and measures the occurrence and severity of side effects up to 35 days after starting treatment. Participants may be followed for up to four years to assess long-term outcomes.

Iadademstat + SBRT With Atezo in ES-SCLC