Lung cancer
Conditions
Interventions
Experimental group: QL1706 plus bevacizumab
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily participate in the study and sign the informed consent. And this study requires the subject to agree to participate in the research of exploratory biomarkers, including the collection of biological samples (such as plasma, serum, archived and tumor specimens obtained in the study) and the exploratory analysis of biomarkers; 2. age >= 18 years old, = 1.5 × 10^9/l (1500/mm3); Platelet (PLT) count >= 100 × 10^9/l (100000/mm3); Hemoglobin >= 90 g/l; b) Liver: serum total bilirubin (TBIL) = 30 ml/min; d) Coagulation function: international normalized ratio (INR) = 2+, 24h urine protein quantification should be performed, and <= 1g can be selected; 13. patients who the investigator believes can benefit.
Exclusion criteria
Exclusion criteria: 1. squamous NSCLC; The 2. presence of EGFR sensitive mutations or ALK gene translocation alterations; 3. previous treatment with pd1/ctla4 bispecific antibody; 4. the adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) grade 1 or below (except for the toxicity of grade 10mg/ day or equivalent dose) or other immunosuppressive drugs within 14 days before the first study medication; 13. patients with a history of immune deficiency, including those with other acquired or congenital immune deficiency diseases, or with a history of organ transplantation, or who have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 14. receive live vaccine within 4 weeks before the first study medication; 15. suffering from severe cardiovascular and cerebrovascular diseases: a) poorly controlled hypertension or pulmonary hypertension; b) Unstable angina or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months before study medication; c) Chronic heart failure and cardiac function >= 2 (NYHA classification of New York Heart Association); d) Left ventricular ejection fraction (LVEF) 450 msec or female QTCF > 470 msec, complete left bundle branch block, degree III conduction block; f) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months before study medication; 16. human immunodeficiency virus (HIV) antibody test results positive, active hepatitis B or C. Participation in this study is allowed under the following circumstances: a) those who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), but whose HBV DNA is lower than the lower limit of the detection value of the research center (negative) or < 500iu/ml, and who are excluded from active infection according to the judgm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Disease Control Rate,DCR;duration of response,DOR;Overall Survival,OS;Adverse Events,AE; | — |
Countries
China
Contacts
Public ContactLi Wei
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed