NCT07022301

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

A Phase II Study Evaluating the Safety and Efficacy of Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti- PD- 1/L1 Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Cancer Extensive Stage
• Resistance to Immunotherapy

Interventions

Type	Name	Description
DRUG	sintilimab combined with anlotinib	Patients who met the inclusion criteria were treated with Sintilimab plus anlotinib every 3 weeks until disease progression or intolerable adverse reactions or death(up to 24 months).

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2025-06-15
• Last updated: 2025-06-15