Phase II Study of Durvalumab with Chemotherapy and Radiotherapy Followed by Durvalumab Maintenance for Limited-Stage Small Cell Lung Cancer

What this Trial Is About

Small-cell lung cancer SCLC is a fast-growing neuroendocrine tumor that accounts for 10% to 15% of new lung cancer cases. Limited-stage SCLC LS-SCLC is diagnosed in about one-third of patients, with standard treatment involving concurrent chemoradiotherapy. Despite advances, only about 20% of patients with LS-SCLC are cured, and relapse or metastasis are common. This phase II pilot study aims to evaluate the safety and effectiveness of combining durvalumab with chemotherapy and radiotherapy followed by durvalumab consolidation therapy for LS-SCLC patients. The treatment involves an induction phase where durvalumab is combined with etoposide and platinum-based chemotherapy cisplatin or carboplatin before thoracic radiotherapy. Following this, patients receive durvalumab consolidation therapy every four weeks for up to 24 months or until disease progression or unacceptable side effects. Radiotherapy to the tumor begins around the third cycle of chemotherapy and is given in specific doses over several days. This is a single-arm, multi-center study focused on this combined treatment approach. Participants will be monitored regularly with imaging scans to assess progression-free survival every 6 weeks during induction and at longer intervals during consolidation, for up to 3 years. Researchers will also track overall survival, response rates, duration of response, and adverse events over approximately 3 years. This comprehensive follow-up includes laboratory tests and clinical evaluations to carefully assess treatment outcomes and safety throughout the study period.

Durvalumab as Consolidation for Patients LS-SCLC