Locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
experimental group:endostar combined with PD-1 antibody and Platinum-based dual drug regimen
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate in clinical research and sign written informed consent; 2. Patients aged 18-75 years old, male and female unlimited; 3. According to TNM stage 8 of International Association for lung cancer research and Joint Committee of American Cancer classification, NSCLC patients with local advanced stage or metastatic stage (III B, III C, IV stage) that can not be treated surgically and can not receive radical concurrent radiotherapy and chemotherapy confirmed by histology or cytology; 4. Primary patients who have not received systemic therapy before; 5. Patients with at least one tumor focus that can be repeatedly measured according to the recist1.1 standard; 6. Be able to provide high-throughput tumor gene detection reports including PD-L1 expression and tumor mutation load (TMB), or provide tumor tissue samples for high-throughput tumor gene detection; 7. Patients with expected survival time >= 3 months; 8. Patients with ECoG status score of 0-1; 9. Organ function level must meet the following requirements: (1) Hematology indexes: neutrophil absolute count >= 1.5 * 10^9 / L, platelet count >= 80 * 10^9 / L, hemoglobin >= 90 g / L; (2) Liver function: total bilirubin = 60ml / min; (4) Coagulation function: INR, Pt and APTT <= 1.5 times the upper limit of normal value; (5) ECG was normal. 10. The serum pregnancy test must be carried out within 3 days before the first administration and the result is negative, and it is not in the lactation period. If having sex with an un sterilized male partner, an acceptable and effective contraceptive method must be taken within 120 days from the beginning of screening to the last administration. If having sex with a female partner of childbearing age, the non sterilized male partner must be screened To take an acceptable and effective contraceptive method within 120 days after the last administration.
Exclusion criteria
Exclusion criteria: 1. Subjects with cancerous meningitis; 2. Subjects with active central nervous system (CNS) metastasis. 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 not use corticosteroids, or receive prednisone (or its 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. Patients with coagulation dysfunction or bleeding tendency, or with history of thrombus or bleeding disease; 6. Subjects undergoing anticoagulation or thrombolysis; 7. Subjects with unhealed wound ulcer or fracture; 8. HBsAg or HCAB were positive, indicating acute or chronic infection; 9. According to the chest X-ray examination, sputum examination and clinical examination, the patients with active tuberculosis (TB) infection were judged. 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 be excluded, unless it is proved that the course and type of anti tuberculosis treatment previously used are appropriate; 10. Subjects with EGFR mutations were excluded (regardless of mutation type). EGFR mutation must be detected in non squamous cell carcinoma subjects with unknown EGFR mutation (PCR based detection is highly recommended). If EGFR mutation is positive, subjects are excluded; 11. Subjects with known ALK translocation were excluded; 12. Patients with original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and stubborn hypertension; 13. Patients known to be allergic to any of the study drugs or their excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| remission rate;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactZhong Lin
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed