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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause

Time frame
24months

Secondary outcomes

1

ORR

the rate of patients with PR and CR

Time frame
24months
2

OS

The time from the beginning of treatment to the time when the patient dies from any cause

Time frame
24months
3

AE

Safety will be evaluated by AE

Time frame
24months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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