NCT07014215

PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy

A Phase II Study Evaluating the Safety and Efficacy of Sintilimab Plus Bevacizumab and Tafolecimab in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the sintilimab combination of bevacizumab and tafolecimab in NSCLC patients who have previously been treated with anti- PD- 1/ligand (L)1 and acquired resistance. The patients were assigned to receive sintilimab(200mg Q3W) in combination with bevacizumab(7.5mg/kg Q3W) and tafolecimab(600 mg Q6W). The primary endpoints of the study were progression- free survival (PFS) assessed by RECISTv1.1 , while secondary endpoints included objective response rate (ORR), and overall survival (OS) and safety.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)
• Resistance to Immunotherapy

Interventions

Type	Name	Description
DRUG	Sintilimab combined with Bevacizumab and tafolecimab	Patients who met the inclusion criteria were treated with sintilimab(200mg Q3W) combined with Bevacizumab(7.5mg/kg Q3W) and tafolecimab(600mg Q6W) until disease progression or intolerable adverse reactions or death(up to 24 months)

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2025-06-10
• Last updated: 2025-06-10