None small cell lung cancer
Conditions
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Stage IIIB-IV non-squamous NSCLC; 2.EGFR sensitive mutation positive; 3.EGFR TKIs treatment progress (1/2/3 generation TKIs); 4.Have received at most one platinum-containing two-drug system chemotherapy in the past or are not suitable for platinum-containing two-drug system chemotherapy; 5.Have not received immunotherapy in the past, including anti-PD-1 drugs, anti-PD-L1 drugs or other drugs; 6.Have not used anti-tumor angiogenesis drugs; 7.ECOG PS 0-1 points.
Exclusion criteria
Exclusion criteria: Exclusion criteria related to disease: 1. The patient has been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4; 2. Patients who have failed treatment with VEGFR TKI anti-tumor angiogenesis drugs; 3. Patients with symptomatic brain metastases, cancerous meningitis, spinal cord compression, or brain or pia mater diseases found on imaging CT or MRI during screening (brain metastases with stable symptoms and no progression after treatment was completed 4 weeks before enrollment Patients can be enrolled, but they need to be evaluated by brain MRI, CT or venography to confirm that they have no symptoms of cerebral hemorrhage); 4. Imaging (CT or MRI) shows that the tumor is less than 5mm away from the large blood vessels, or there is a central type tumor that invades the local large blood vessels, or has a high risk of bleeding; or there is obvious lung cavity or necrotic tumor; 5. Clinically significant hemoptysis (at least 0.5 teaspoon of fresh blood) or tumor bleeding occurred within 2 weeks before the first administration of the study treatment; or significant clinically significant bleeding symptoms or a clear bleeding tendency; 6. The patient is accompanied by refractory pleural effusion or ascites, such as pleural effusion or ascites that requires puncture and drainage within 2 weeks before the first administration; 7. Other malignant tumors that have appeared in the past 2 years or are currently at the same time, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (formerly Position carcinoma) and T1 (tumor infiltrating basement membrane)]; 8. Patients whose adverse reactions related to anti-tumor therapy (except for alopecia) have not recovered to NCI-CTCAE = 500IU/mL (2500 copies/mL) chronic hepatitis B virus carriers (only for hepatitis B core antibody patients with positive test should be tested for HBV DNA); b. HCV RNA test positive for patients (only HCV RNA test for hepatitis C virus antibody positive patients); 12. For active autoimmune diseases that require systemic treatment, the investigator evaluates patients who are deemed to have an impact on the study treatment; 13. Long-term massive use of hormones or use of other immunomodulators, and the investigator assesses patients who are deemed to have an impact on the research treatment; 14. People with active infection; 15. Live or attenuated vaccine was vaccinated within 30 days before the first administration of tislelizumab, or plan to vaccinate live or attenuated vaccine during the study period; 16. Regardless of the severity, patients with any signs of bleeding or medical history; patients with any bleeding or bleeding within 4 weeks before grouping, with unhealed wounds, ulcers or fractures; 17. Have a bleeding tendency or are receiving thrombolysis or anticoagulant therapy; Note: Under the premise that the international normalized ratio (INR) of the history of thrombin disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;duration of remission;disease control rate;NCI-CTCAE version 5 evaluated the safety of the treatment; | — |
Countries
China
Contacts
Public ContactZhang Li
Peking Union Medical College Hospital
Outcome results
None listed