Lung Cancer
Conditions
Interventions
Experimental group:carrelizumab + bevacizumab+pemetrexed
Control group:camrelizumab +pemetrexed+carboplatin
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years and = 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, exclusion criteria, hemoglobin >= 90 g / L; 8. Adequate liver function: aspartate aminotransferase (AST) = 50ml / min (Cockcroft Gault formula); 10. Sufficient coagulation function: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the upper limit of normal; if the patient is receiving anticoagulant therapy, INR / PT is within the range of anticoagulant drugs; 11. Patients need to use high-efficiency contraception until at least 180 days after stopping the trial treatment. It was confirmed that the urine pregnancy test or serum pregnancy test was negative within 3 days before the first study drug administration. 12. Subjects who understood and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with squamous cell or mixed type NSCLC with squamous cell morphology. 2. Mixed type lung cancer with small cell carcinoma, neuroendocrine carcinoma and sarcomas can not be included; 3. Patients with EGFR mutation, ALK fusion mutation, c-Met mutation, ros-1 mutation, etc. 4. Patients who have suffered from any arterial thrombosis, embolism or ischemic or hemorrhagic diseases in the past 6 months and have not improved or become unstable after corresponding treatment, such as unstable myocardial infarction, unstable angina pectoris, cerebrovascular accident, etc; 5. For patients with hemoptysis in recent 3 months, the amount of bleeding was defined as bright red blood greater than or equal to 2.5ml. 6. Patients diagnosed with other malignant tumors in the past five years, not including skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ after radical resection; 7. Patients who have been proved to be allergic or contraindicated to karelizumab, bevacizumab, pemetrexed or their excipients; 8. Patients with NSCLC who do not receive chemotherapy or are expected to be intolerable to chemotherapy; 9. It interferes with the clinical trial, hinders the whole process participation of the subjects, or the researchers think it is not in the best interests of the subjects; 10. Patients with grade 2 or above hypertension before treatment and no improvement or instability after antihypertensive drug treatment; patients with hypertensive crisis or hypertensive encephalopathy; 11. Patients with nephrotic syndrome or proteinuria >= 2 + or above before treatment, and patients without improvement or instability after treatment; 12. Patients who need surgical treatment in the past 60 days; 13. Patients with history of gastrointestinal perforation in recent 6 months; 14. Patients with previous history of severe brain diseases, especially those with grade III / IV white matter lesions; 15. Patients with congenital or acquired immune deficiency (such as HIV) Patients with autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism (only those who can be controlled by hormone replacement therapy can be included) Skin diseases without systemic treatment, such as vitiligo, psoriasis and alopecia, controlled type I diabetes treated with insulin or asthma in childhood, and without any intervention in adulthood, can be included; asthma patients who need bronchodilator for medical intervention can not be included; sixteen Patients with previous and current history of pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), interstitial pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia or severe impairment of lung function on chest computed tomography (CT) during screening may interfere with the detection and management of suspected drug-related pulmonary toxicity The patients had radiation pneumonitis, active tuberculosis, and other diseases; 17. Patients with active hepatitis B virus (HBV) infection: HBV DNA must be less than 500 IU / ml (if the research center has only copy / ml testing unit, it must be less than 2500 copy / ml), and anti HBV treatment must be received at least 14 days before the start of the study Treatment (according to local standard treatment, such as entecavir) and willing to receive antiviral treatment throughout the study period; 18. Pat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;DOR;safety; | — |
Countries
China
Contacts
Public ContactJie Liu
Shandong Cancer Hospital
Outcome results
None listed