drugset / Trial / NCT07022301
Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 8 mg | Oral |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |