Lung Cancer
Conditions
Interventions
Group 2:Camrelizumab + pemetrexed + carboplatin / cisplatin
Group 1:Bevacizumab + pemetrexed + carboplatin / cisplatin
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. sign the informed consent; 2. the researcher judges that they can comply with the research plan; 3. Aged 18-70 years old at the time of signing the informed consent, both male or female; 4. subjects with histologically or cytologically confirmed non-squamous cell carcinoma of non-small cell lung cancer (NSCLC) and stage IV tumor (as determined by the eighth edition of the American joint committee on cancer staging manual); 5. the research center must be able to provide relevant documentation of the subjects' EGFR mutation and ALK fusion gene status, and all of them must be negative. Subjects were not randomized prior to the acquisition of EGFR mutation and ALK fusion gene status as documented in the study center source files. The research center must be able to provide documents on the expression level of pd-L1 in subjects' tumor tissues. The expression level of pd-L1 must be detected by one of the following 28-8/22c3 /SP263 antibodies. TPS score of subjects' pd-L1 tumor cells is =3 months; 11. all screening period laboratory tests are performed in accordance with protocol requirements and within 14 days prior to initial administration. The values of the laboratory tests performed for screening must meet the following criteria: (1) Blood routine examination: (No blood transfusion, no use of G-CSF, no medication correction within 14 days before screening) hemoglobin (HB) >=90g/L; absolute value of neutrophil count (ANC) >=1.5x10^9/L; platelet count (PLT) >=100x10^9/L; white blood cell count (WBC) 4.0 to 15x109/L; (2) biochemical examination: (no blood transfusion or albumin within 14 days before screening) AST and ALT=60 mL/min (Cockcroft-Gault formula); APTT<=1.5 ULN, and INR or PT<=1.5 ULN (no anticoagulation treatment); (3) The HIC test result was negative during screening; (4) when screening hepatitis b surface antigen (HBsAg) test results negative; At the time of screening, the hepatitis b core antibody (HBcAb) test results were negative, or at the time of screening, the hepatitis b core antibody (HBcAb) test results were positive but the s
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for target disease: 1) subjects with other histopathological types of non-small cell lung cancer were excluded, including subjects with mixed squamous adenocarcinoma and NSCLC subjects with small cell lung cancer and neuroendocrine carcinoma. 2) exclude EGFR mutation or ALK fusion positive subjects. 3) excluded subjects with unmeasured lesions. 4) subjects with cancerous meningitis and spinal cord compression were excluded. 5) subjects with untreated central nervous system (CNS) metastases were excluded. If subjects with CNS metastasis limited to supratentorial and / or cerebellum have received adequate treatment and maintained clinical stability (enhanced MRI or CT imaging detection, preferred) for at least 4 weeks, and the clinical symptoms such as nervous system of subjects can recover to NCI-CTC AE = 1 degree at least 2 weeks before the first medication, they can participate in research. In addition, subjects who were treated with corticosteroids for related clinical symptoms were excluded from the study unless they received at least 2 weeks of prednisone (or its equivalent) with a steady or gradual decrease in dose 10 mg/ day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to initial administration were excluded. In the absence of active autoimmune disease, inhaled or topical administration of corticosteroids and adrenal hormone replacement therapy with a dose of > 10 mg/ day prednisone is permitted; 3) subjects who had been treated with anti-tumor vaccine or other immunostimulant anti-tumor drugs (interferon, interleukin, thymosin, immunocell therapy, etc.) within 1 month before the first medication were excluded; 4) subjects who were enrolled in other clinical studies or whose first use of the drug was less than 4 weeks (or 5 half-lives of the drug in the study) from the end of the previous study (last administration); 5) subjects who are expected to require any other form of antitumor therapy (including maintenance therapy of other NSCLC medications, radiotherapy, and/or surgical resection) in the study; 6) subjects who received major surgery within 4 weeks before the first administration, non-chest radiotherapy of >30 Gy within 4 weeks before the first administration, chest radiotherapy of >30 Gy within 24 weeks before the first administration, and palliative radiation <=30 Gy within 2 weeks before the first administration and subjects who failed to recover from the toxicity and/or complications of these interventions to nci-ctc AE <=1 degree (except hair loss and fatigue); 7) subjects with highly suspected interstitial pneumonia; Or subjects who may interfere with the detection or management of suspected drug-rel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai Pulmonary Hospital
Outcome results
None listed