Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

NCT Number	NCT07022301
Lead Sponsor	First Affiliated Hospital of Wannan Medical College
Conditions	Small Cell Lung Cancer Extensive Stage, Resistance to Immunotherapy
Enrollment	25 participants
Start Date	2025-07
Primary Completion	2027-05 (estimated)
Study Completion	2029-05 (estimated)
Updated on ClinicalTrials.gov	2025-06-15