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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnhui Provincial Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

1. Sign written informed consent before implementing any experimental procedures

2. Age ≥ 18 years old and ≤ 80 years old

3. Histological or cytological confirmation of locally advanced (IIIB-IIIC), metastatic or recurrent (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on Cancer Classification 9th edition TNM lung cancer staging)

4. Failure after previous treatment with PD - (L) 1 inhibitors (alone or in combination with another systemic therapy) (CR, PR, SD>6 months)

Disqualifiers

1. Pathological diagnosis of small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC

2. The patient has received first-line or more PD - (L) 1 inhibitor monotherapy or combination chemotherapy treatment

Received systemic anti-tumor therapy within 3 weeks prior to treatment, such as chemotherapy, targeted therapy, immunotherapy (including herbal therapy with anti-tumor indications), etc

Received any investigational drug treatment within 4 weeks prior to treatment

Trial design

Treatments tested in this trial

  • Sintilimab combined with Bevacizumab and tafolecimab

Treatment groups

52 Participants
are divided into 1 treatment group

Locations

This trial has no locations