EGFR-TKI-resistant PD-L1-positive EGFR-mutated non-small cell lung cancer (NSCLC)
Conditions
Interventions
Immunotherapy combined with chemotherapy group:Immunotherapy combined with chemotherapy
Targeted therapy combination group:Targeted therapy combination
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form and follow the protocol requirements; 2. Age greater than 18 years old; 3. ECOG score less than 2; 4. Have histological or pathological confirmed primary NSCLC; 5. According to the TNM staging (2017 Eighth Edition), the clinical stage is stage IV; 6. Contains EGFR sensitive mutations (including Ex21 L858R, Ex19 del, etc.); 7. During the application of 3rd generation EGFR-TKI (osimertinib, aminatacinib, volmetinib, etc.), extensive disease progression of the disease is evaluated to meet the RECIST 1.1 criteria through CT and other imaging assessments; 8. Tumor tissue PD-L1 expression level is positive (TPS, CPS, TC/IC are all applicable).
Exclusion criteria
Exclusion criteria: 1. Has a history of other malignant tumors (excluding those that have been clinically cured, such as papillary thyroid carcinoma, breast cancer, clear cell renal carcinoma, etc.); 2. Has uncontrolled acute or chronic infections; 3. Has uncontrolled brain metastases; 4. Has meningeal metastases; 5. Has active autoimmune diseases; 6. Has active tuberculosis infection; 7. Has active infections requiring systemic treatment; 8. HIVAb positive, active hepatitis B (HBsAg positive and HBV-DNA > 1000 copies/ml) or hepatitis C (HCV antibody positive and HCV-RNA > the detection limit of the center); 9. Has a history of severe heart disease or cerebrovascular disease; 10. Has unstable thrombotic events that require treatment intervention within 6 months before screening; 11. The researcher determines that the laboratory test indicators such as white blood cell count, liver and kidney function are not suitable for chemotherapy, such as WBC < 3×10^9/L, NEU < 1.5×10^9/L, PLT < 90×10^9/L, etc.; 12. Patients with EGFR-independent drug resistance need to be excluded. Specifically, the following types are included: 1. MET amplification (especially the incidence can reach 15% after first-line osimertinib treatment) 2. HER2 alteration, BRAF or KRAS mutation 3. Receptor tyrosine kinase (RTK) gene fusion 4. Histological transformation (such as transformation from small cell lung cancer); 13. Other situations that the researcher considers not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival period;Safety ;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactXu Jiachen
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed