NSCLC
Conditions
Interventions
control group:Endostar combined with chemotherapy
experimental group:Endostar, PD-1/PD-L1 and conventional chemotherapy
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to TNM stage of lung cancer (8th Edition) issued by International Association for lung cancer research and Joint Committee of American Cancer classification, NSCLC which is proved by histology or cytology and can not be treated surgically and can not receive radical concurrent radiotherapy and chemotherapy in local advanced stage or metastatic stage (III B, III C or IV stage). 2. NSCLC with EGFR gene mutation negative and alk negative were detected. 3. Patients who have not received systemic radiotherapy and chemotherapy before or who have been followed up for more than 6 months after adjuvant chemotherapy. 4. There must be at least one evaluable lesion judged according to rrecist standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm). 5. Men or women aged 18 to 75 years. 6. ECoG PS 0 or 1. 7. Estimated survival time >= 12 weeks. 8. Adequate blood function: absolute neutrophil count (ANC) >= 2 x 10^9 / L, platelet count >= 100 x 10^9 / L and hemoglobin >= 9 g / dl. 9. Adequate liver function: total bilirubin = 60ml / min. 11. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of the study and the patients have recovered. 12. Women with complete uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months since amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for validation (within 7 days before the first administration). 13. Sign the informed consent (the informed consent needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure).
Exclusion criteria
Exclusion criteria: 1. The subjects had cancerous meningitis. 2. Subjects with active central nervous system (CNS) metastasis were excluded. Subjects may participate in the study if their CNS metastasis is adequately treated and their neurological symptoms return to baseline at least 2 weeks prior to inclusion (except for residual signs or symptoms related to CNS treatment). In addition, the subjects must be subjects who do not use corticosteroids, or receive prednisone (or equivalent) with a stable or gradually reduced dose of 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment. Subjects who used inhaled or topical corticosteroids, and subjects whose doses of corticosteroid replacement therapy were equivalent to > 10 mg prednisone / day, could participate in the study if there was no active autoimmune disease. 5. Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV AB) is positive, indicating acute or chronic infection. 6. According to the chest X-ray examination, sputum examination and clinical examination, it is judged that there is active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than one year ago should also be excluded unless it is proved that the course and type of anti tuberculosis treatment used before are appropriate. 7. The former serious heart disease includes congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and stubborn hypertension. 8. Pregnant or lactating patients. 9. The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures. 10. At the same time, they received experimental treatment of other clinical studies (in the treatment period of clinical studies). 11. Known to be allergic to chemotherapy drugs that may be used. 12. There is evidence to prove that patients with other diseases, abnormal neurological or metabolic functions, abnormal physical examination or laboratory examination may be suspected of contraindications to the study drug or high risk of complications related to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Overall survival;AEs; | — |
Countries
China
Contacts
Public ContactZeng Aiping
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed