Phase II Study of Atezolizumab Plus Rechallenge Chemotherapy for Sensitive Relapse in Extensive-Stage Small Cell Lung Cancer Progressing After First-Line Platinum-Etoposide and PD-L1 Inhibitor Treatment

What this Trial Is About

Researchers are evaluating if a combination of atezolizumab and standard chemotherapy can improve treatment outcomes for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer ES-SCLC who have progressed after first-line treatment with platinum-etoposide chemotherapy plus PD-L1 inhibitors like atezolizumab or durvalumab. This phase II trial is designed to find out if continuing PD-L1 inhibition along with rechallenge chemotherapy increases overall survival and to monitor medical problems participants may experience. Eligible patients receive induction treatment with atezolizumab 1200 mg given intravenously on day 1 every 3 weeks along with carboplatin and etoposide chemotherapy for up to 4 cycles. After induction, patients continue maintenance therapy with atezolizumab every 3 weeks for up to 18 cycles or one year. Treatment continues until disease progression, unacceptable side effects, patient choice, or loss of clinical benefit. The study spans an expected 45 months, including 24 months for recruitment, 15 months maximum treatment duration, and up to 6 months of follow-up. Participants visit the clinic every 3 weeks for treatment, checkups, and tests. Radiological assessments using CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to check treatment response. Researchers continuously monitor safety and adverse events during treatment. The primary outcome is overall survival over about one year, with additional measures including progression-free survival and the frequency of adverse events. Participants are closely observed throughout the study to evaluate treatment effects and safety.

Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).