Non-small cell lung cancer
Conditions
Interventions
Experimental Group:Adebrelimab+Apatinib+Chemotherapy
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, regardless of gender; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2; 3. life expectancy more than 3 months; 4. Histologically or cytologically confirmed stage IV non-small cell lung cancer (according to the 8th edition of the International Association for the Study of Lung Cancer Staging Manual for Thoracic Tumors); 5. no EGFR mutation or ALK or ROS1 gene rearrangement; 6. According to RECIST 1.1 criteria, patients had at least one target lesion with measurable diameter (tumor lesion with major diameter >=10 mm on CT scan, lymph node lesion with minor diameter >=15 mm on CT scan, and slice thickness = 1.5×10^9/L, platelet count >= 100×10^9/L, and hemoglobin >= 90g/L[no blood transfusion or erythropoietin (EPO) dependence within 7 days]; Good liver function was defined as total bilirubin level = 2+, 24-hour urine should be collected and the 24-hour urine protein quantitative test should be proved to be <= 1 g. Good coagulation function was defined as INR or prothrombin time (PT) <= 1.5 ULN; 9. For reproductive-age female subjects, a negative urine or serum pregnancy test should be obtained within 3 days before receiving the first dose of study drug (cycle 1, day 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. If there was a risk of conception, male and female patients were required to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) until at least 180 days after discontinuation of the trial treatment; 10. be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: 1. Histologically small cell lung cancer (SCLC) and mixed squamous and glandular non-small cell lung cancer (NSCLC); 2. are currently participating in an interventional clinical trial, or have received another study drug or investigational device within weeks before the first dose; 3. allergy to any component of the study drug; 4.active brain metastases; Patients with asymptomatic brain metastases were eligible. Patients with clinically suspected central nervous system metastases had to undergo CT or MRI within 28 days before enrollment to rule out central nervous system metastases. 5. patients with history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF >=450 ms in men and >=470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) grade >= II cardiac dysfunction. 6. Urine routine test showed urinary protein >=++ and confirmed 24-hour urinary protein quantitation >1.0 g; 7. infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; A history of chronic autoimmune diseases, such as systemic lupus erythematosus; He had a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome. A history of sarcoidosis or tuberculosis; Patients with a history of active hepatitis B or C, and HIV infection; 8. have a history of psychotropic drug abuse and cannot quit or have mental disorders; 9. symptomatic pleural or peritoneal effusion requiring clinical intervention; 10. concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or prevent the patient from completing the study; 11. other conditions deemed by the investigator to be ineligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Immune-related objective response rate;Immune-related disease control rate;Immune-related progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactQuan Liu
Affiliated Hospital of Jiangnan University
Outcome results
None listed