PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy
- Sponsor
- Anhui Provincial Cancer Hospital
- Study ID
- NCT07014215
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer)
- Resistance to Immunotherapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sintilimab combined with Bevacizumab and tafolecimab — DRUGPatients 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)
Study Details
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.
Key Dates
- First listed
- Jun 10, 2025
- Start date
- Jun 30, 2025
- Status verified
- Jan 2025
- Primary completion
- May 31, 2027
- Completion
- May 31, 2029
Study Design
- Enrollment
- 52 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental armDrug: Sintilimab combined with bevacizumab and tafolecimab
Primary Outcome Measure
PFS [ Time Frame: 24months ]
Central Contacts
- Zhihong Zhang0551-65327766
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