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 volunteersQualifiers
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
Single group
Treatments tested in this trial
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)
Treatment groups
Trial outcomes
Primary outcomes
PFS
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
Secondary outcomes
ORR
the rate of patients with PR and CR
OS
The time from the beginning of treatment to the time when the patient dies from any cause
AE
Safety will be evaluated by AE
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: