drugset / Trial / NCT07022301

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

NCT07022301 ↗

Phase 2 Not yet recruiting 25 enrolled First Affiliated Hospital of Wannan Medical College
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-07
Primary completion
2027-05
Completion
2029-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 8 mg Oral
Subject Catequentinib Small molecule 12 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous