Phase II Study of Adjuvant Chemotherapy and Immunotherapy Using Durvalumab for Patients With Completely Removed Small Cell Lung Cancer

What this Trial Is About

Researchers are conducting a phase II open-label, single-arm, multi-center study to evaluate the effectiveness and safety of adjuvant chemotherapy combined with immunotherapy for patients with completely resected small cell lung cancer SCLC classified as pathologic T1-T2, N0-N1, M0. The study aims to improve 2-year disease-free survival rates while assessing treatment safety over several years. Participants receive a combination treatment beginning with 1500 mg of durvalumab plus either cisplatin 75 mgm2 or carboplatin AUC 5 on day 1, along with etoposide 100 mgm2 on days 1 to 3, repeated every 3 weeks for 4 cycles 12 weeks total. After this chemotherapy and immunotherapy combination, they continue with durvalumab 1500 mg every 4 weeks for an additional 9 cycles 36 weeks total. The study enrolls about 65 participants. During the study, participants undergo regular monitoring for disease-free survival at 2 years, overall survival at 3 years, and treatment safety up to 5 years. Assessments include clinical evaluations and safety monitoring. The total participation spans several years, allowing researchers to observe long-term outcomes and adverse effects of the treatment.

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer