To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, randomised, multicenter, Phase II study. This study is planned to
enroll 80 eligible patients to receive durvalumab combined with up to 4 cycles of etoposide
and platinum-based chemotherapy (EP). And approximately 64 patients who complete the 4 cycles
of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be
randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or
durvalumab (Arm 2) until confirmed progressive disease. Prophylactic cranial irradiation
(PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients
will attend a safety follow up visit 90 days after last dose of durvalumab. Tumor assessments
will be performed at Screening with follow-up at Week 6 ±1 week and Week 12 ±1 week from the
date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective
disease progression.