lung cancer
Conditions
Interventions
Case series:Tilelizumab combined with chemotherapy
Sponsors
Shanghai Chest Hospital, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Based on the eighth edition of AJCC staging, histological or cytological examination confirms that patients with locally advanced (IIIB/C) or metastatic (IV) non-squamous NSCLC who cannot undergo radical surgery or radiotherapy; 2. EGFR-sensitive mutations before EGFR-TKI treatment: 19del, L858R or other sensitive mutations (including: G719X, S786I, L861Q mutations, etc.) that have been proven in the literature, patients need to provide the test results of the certified testing platform; 3. EGFR-TKI treatment fails and meets any of the following requirements: (1) 1/2-generation EGFR-TKI (such as: erlotinib, gefitinib, icotinib, afatinib, etc.) treatment progress, patients with T790M- confirmed by the central laboratory; patients must provide resistance The post-medicine specimens are tested for EGFR T790M, and histological samples are preferred; (2) T790M+ 1/2-generation EGFR-TKI treatment progresses in patients who receive third-generation EGFR-TKI (Ositinib or other third-generation EGFR-TKIs on the market in China) and the treatment progresses again, and they must meet to take the third-generation EGFR-TKI Disease progression after more than 6 months); (3) T790M status is not considered for patients who have progressed initially on Ositinib treatment. 4. ECOG PS 0-1; 5. Life expectancy is greater than 3 months. Hematology, biochemistry and organ function (need to be confirmed by the examination results within 7 days before the first administration): 6. Absolute neutrophil count (ANC) >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=90 g/L; 7. International normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN; 8. Activated partial thromboplastin time (aPTT)<=1.5 ULN; 9. Serum total bilirubin<=1.5 ULN; 10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 ULN. If the patient has liver metastases, the standard is AST and ALT <=5 ULN. 11. Be able to provide written informed consent, and be able to understand and agree to comply with the research requirements and evaluation schedule; 12. Male or female aged 18-75 years; 13. Patients with fertility must be willing to take effective contraceptive measures during the study period and within 120 days after the last dose of tislelizumab.
Exclusion criteria
Exclusion criteria: 1. The patient has been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy; 2. Patients who have received systemic platinum-containing dual-drug chemotherapy as advanced treatment; 3. The patient receives other approved systemic anticancer treatments or systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor) 4 weeks before the first administration; 4. The patient is accompanied by refractory pleural fluid or ascites, such as pleural fluid or ascites that requires puncture and drainage within 2 weeks before the first administration; 5. With active leptomeningeal disease or brain metastases, if there are central nervous system symptoms, interventional treatment (including but not limited to radiotherapy, lowering intracranial pressure, etc.) is required; 6. Any allergy to study drugs or excipients; 7. Creatinine clearance rate =500IU/mL (2500 copies/mL) (HBV DNA testing is only performed on patients who test positive for hepatitis B core antibody ); (2) HCV RNA test positive patients (HCV RNA test only for hepatitis C virus antibody positive patients); 9. For active autoimmune diseases that require systemic treatment, the investigator assesses patients who have an impact on the research treatment; 10. The long-term use of hormones or other immunosuppressive agents, and the investigator assesses patients who have an impact on the research treatment; 11. Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection. 12. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 13. Known human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactXueyan Zhang
Shanghai Chest Hospital, Shanghai Jiao Tong University
Outcome results
None listed