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 — DRUG
    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)

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 arm
    Drug: Sintilimab combined with bevacizumab and tafolecimab

Primary Outcome Measure

PFS [ Time Frame: 24months ]

Central Contacts

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