lung cancer
Conditions
Interventions
single arm:Adebelizumab (1200 mg, i.v., d1) + bevacizumab (7.5 mg/kg, i.v., d1) + pemetrexed (500 mg/m2, i.v., d1) + platinum (at investigator's discretion), Q3W.
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. male or female patients, aged 18-75 years; 2. an ECOG score of 0-1; 3. subjects with recurrent or metastatic NSCLC with EGFR mutations diagnosed by histopathology and cytopathology; 4. progression after treatment with a third-generation EGFR-TKI; 5. without immune checkpoint inhibitor and/or anti-angiogenic therapy; 6. patients with at least one target lesion with a measurable radial line according to RECIST 1.1 criteria; 7. prior radiotherapy is permitted provided that the area of radiotherapy is 10 mg/day prednisone or equivalent dose) within 2 weeks prior to enrollment ; 11. Vital organ function within 1 week prior to enrollment meets the following criteria: (1) blood routine: white blood cell (WBC) = 3.0 × 10^9/L; absolute neutrophil count (ANC) = 1.5 × 10^9/L; platelet (PLT) = 100 × 10^9/L. (2) blood count = 1.5 × 10^9/L; platelets = 100 × 10^9/L. (3) no need to receive systemic corticosteroid hormone (>10 mg/day prednisone or equivalent dose within 2 weeks prior to enrollment. (2) Liver function: aspartate transferase (aspartate transferase, AST) = 2.5 × ULN, alanine aminotransferase (ALT) = 2.5 × ULN. ALT) = 2.5 × ULN, liver metastasis subjects with ALT and AST = 5 × ULN; serum total bilirubin (total bilirubin, TBIL) = 1.5 × ULN (except for Gilbert's syndrome = 3 × ULN); albumin (albumin, ALB) = 30.0 g/L. (3) renal function: serum creatinine = 1.5 × ULN or creatinine clearance rate. (3) Renal function: serum creatinine = 1.5 × ULN or creatinine clearance rate (CrCl) = 50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: international normalized ratio (INR) = 1.5, activated partial thromboplastin time (ACT) = 1.5, and activated partial thromboplastin time (APT) = 1.5, and activated partial thromboplastin time (APT) = 1.5. (4) Coagulation function: international normalized ratio (INR) = 1.5, activated partial thromboplastin time (APTT) = 1.5 × ULN (5) Others: lipase = 1.5 × ULN; if lipase > 1.5 × ULN without clinically or imaginatively proven pancreatitis, the patient can be enrolled; amylase = 1.5 × ULN; if amylase > 1.5 × ULN without clinically or imaginatively proven pancreatitis, the patient can be enrolled; and if the patient has no clinically or imaginatively proven pancreatitis, the patient can be enrolled; and amylase = 1.5 × ULN. If amylase > 1.5 × ULN without clinical or imaging evidence of pancreatitis, enrollment is allowed. Alkaline phosphatase (ALP) = 2.5 × ULN, and in subjects with bone metastases, ALP = 5 × ULN (6) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50
Exclusion criteria
Exclusion criteria: 1. patients with brain metastases, but patients with asymptomatic brain metastases may be enrolled; 2. patients with meningeal metastases; 3. patients diagnosed with active autoimmune diseases (congenital or acquired), such as interstitial pneumonitis (patients with vitiligo in complete remission are eligible for enrollment; patients with hypothyroidism and needing only hormone replacement therapy may be reenrolled; patients with type I diabetes mellitus may also be enrolled); 4. patients with bleeding tendency, including acute gastrointestinal bleeding, persistent bleeding disorders or coagulopathies 5. hypersensitivity to any component of the study drug; 6. Non-surgically sterilized or female patients of childbearing potential must have a negative serum HCG test within 72 hours prior to the first dose of study drug and must not be breastfeeding, and must agree to use appropriate contraception (e.g., intrauterine device, birth control pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; male patients must agree to use appropriate contraception during the study treatment period and for 3 months after the end of the study treatment period. Male patients agree to use an appropriate method of contraception during and for 3 months after the end of study treatment; 7. Patients who are participating in other interventional studies; 8. Any other circumstances that, in the judgment of the investigator, make inclusion in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective mitigation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of relief;Disease control rate;Quality of Life Score;Adverse event; | — |
Countries
CHINA
Contacts
Public ContactLingxiang Liu
Jiangsu Provincial People's Hospital
Outcome results
None listed