Phase 2 Study of Sacituzumab Govitecan Combined With Atezolizumab or Durvalumab as Maintenance Treatment for Adults With Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of sacituzumab govitecan SG with either atezolizumab or durvalumab as maintenance therapy for adults with extensive stage small cell lung cancer SCLC. This phase 2 study aims to see if this combination can better control tumor growth and improve survival after prior platinum-based chemotherapy and immunotherapy. SCLC is a fast-growing lung cancer with poor prognosis, and current treatments only modestly improve survival. Participants will receive sacituzumab govitecan at 10 mgkg by IV infusion on days 1 and 8 of a 21-day cycle, combined with either atezolizumab 1200 mg or durvalumab 1500 mg IV on day 1 every 21 days. Treatment will continue for up to 2 years or until disease progression, unacceptable side effects, withdrawal, or death. Imaging scans including CT and MRI brain will be done regularly to monitor tumor status. Optional tissue and blood samples will be collected for additional cancer research. During the trial, participants will have safety assessments before each treatment cycle. Dose adjustments may be made as needed. After treatment ends, safety follow-up occurs about 30 days later. Long-term follow-up with imaging and survival checks continues until death or study end. The main outcome is disease control at 12 weeks, with secondary measures including overall survival, progression-free survival, and treatment side effects. The total participation duration may last up to 2 years or more depending on treatment and follow-up.

Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer