Non-Small Cell Lung Cancer
Conditions
Interventions
Tislelizumab+chemotherapy group:Tislelizumab+chemotherapy
Sponsors
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced (stage IIIB/C) or metastatic (stage IV) NSCLC confirmed by histological or cytological examinations based on the eighth edition of AJCC staging, who cannot undergo radical surgery or radiotherapy; 2. BRAF-sensitive mutation before immunotherapy: BRAF gene is a serine/threonine kinase, which is part of the typical MAP/ERK signaling pathway. BRAF activating mutations lead to uncontrolled signaling through the MAP/ERK pathway. (including: V600E and non-V600E mutations, etc.), the patient needs to provide the test results of the certified test platform; 3. ECOG PS: 0-2; 4. Life expectancy is more than 3 months; 5. Absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >=90 g/L; 6. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; 7. Activated partial thromboplastin time (aPTT) <= 1.5 x ULN; 8. Serum total bilirubin<=1.5 ULN; 9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 ULN, if the patient has liver metastases, this criterion is AST and ALT <= 5 ULN; 10. Be able to provide a written informed consent form (ICF), and be able to understand and agree to abide by the research requirements and evaluation schedule; 11. Male or female aged 18-75 at the time of signing the ICF.
Exclusion criteria
Exclusion criteria: 1. The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy; 2. Patients received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor) 4 weeks prior to the first dose; 3. Patients with refractory pleural effusion or ascites; 4. Patients with active leptomeningeal disease or brain metastases; 5. Allergy to any research drug or excipients; 6. Creatinine clearance <45mL/min; 7. Patients with active viral hepatitis who need treatment as determined by the investigator; 8. Active autoimmune diseases that require systemic treatment, and patients who are considered to have an impact on the study treatment as assessed by the investigator; 9. Patients with long-term heavy use of hormones or other immunosuppressive agents, who are considered to be affected by the research treatment according to the investigator's assessment; 10. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection, etc.: (1) Serious infection requiring hospitalization within 4 weeks before the first dose, including but not limited to complications of infection, bacteremia or severe pneumonia; (2) Receive oral or intravenous antibiotics within 2 weeks before the first dose; 11. History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 12. Any major surgery requiring general anesthesia has been performed within <= 28 days prior to the first dose; 13. There is an underlying medical condition or alcohol/drug abuse or dependence that is not conducive to the administration of the study drug, or may affect the interpretation of the results, or put the patient at a high risk of treatment complications; 14. Participate in another therapeutic clinical study at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;overall survival;duration of relief; | — |
Countries
China
Contacts
Public ContactGao Beili
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Outcome results
None listed