EGFR/ALK negative stage II-III non-small cell lung cancer
Conditions
Interventions
Primary foci in the lung group:None
Sponsors
Henan Provincial People's Hospita,medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 18 years; 2. Pathologically confirmed resectable stage II-III non-small cell lung cancer, with indications for surgical resection; 3. No driver gene mutations (EGFR, ALK negative); 4. PD-L1 expression testing before neoadjuvant chemotherapy combined with immunotherapy; 5. Laboratory test results before neoadjuvant treatment indicating normal organ function: absolute neutrophil count >=1.5 × 10^9/L; platelets >=75 × 10^9/L; hemoglobin >=90 g/L; estimated glomerular filtration rate (GFR) by the CKD-EPI equation >=45 mL/min/1.73 m^2; total serum bilirubin <=1.5 × upper limit of normal (ULN); AST and ALT <=2.5 × ULN; for patients not on anticoagulation therapy: international normalized ratio or activated partial thromboplastin time <=1.5 × ULN; 6. Received 2-4 cycles of platinum-based neoadjuvant chemotherapy combined with immunotherapy (PD-1/PD-L1 inhibitors); 7. Availability of clinical and pathological data, imaging data, routine blood/biochemical indicators, immune-related markers, and tumor marker test results required for retrospective analysis.
Exclusion criteria
Exclusion criteria: 1. Patients with neuroendocrine carcinoma components; 2. Received systemic anti-tumor therapy except chemotherapy combined with immunotherapy during neoadjuvant therapy; 3. Mutations in EGFR and ALK sensitive driver genes; 4. No pre-treatment PD-L1 detection information; 5. Presence of locally advanced, unresectable disease, regardless of disease stage and presence of metastases (stage IV); 6. 10 mg/day) or other immunosuppressive drugs; 8. History of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.; 9. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg); (2) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >=440ms) and >=grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (>=CTC AE grade 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (7) Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L); (8) Urine routine showed urine protein >= and confirmed 24-hour urine protein quantitative > 1.0 g; (9) Patients with seizures and requiring treatment; Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Patients with incomplete data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR;Pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| N2 lymph node descent period; | — |
Countries
China
Contacts
Public ContactHuizhen Yang
Henan Provincial People's Hospita,medical
Outcome results
None listed