Non-small cell lung cancer
Conditions
Interventions
Primary lung lesion group:None
PD-L1 negative group:None
PD-L1 positive group:None
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Pathologically confirmed stage II–III resectable non-small cell lung cancer (NSCLC) with clinical indication for surgical resection; 3. Absence of driver gene mutations (negative for EGFR and ALK); 4. Received 2 to 4 cycles of platinum-based neoadjuvant chemotherapy combined with immunotherapy (PD-1/PD-L1 inhibitors); 5. Adequate organ function as indicated by laboratory values prior to neoadjuvant treatment: absolute neutrophil count >= 1.5 × 10^?/L; platelet count >= 75 × 10^?/L; hemoglobin >= 90 g/L; estimated glomerular filtration rate (eGFR) >= 45 mL/min/1.73 m^² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; total serum bilirubin <= 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN; for patients not receiving anticoagulation therapy: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with neuroendocrine carcinoma components; 2. Receipt of any systemic anti-tumor therapy other than chemotherapy combined with immunotherapy during neoadjuvant treatment; 3. Presence of EGFR or ALK-sensitive driver gene mutations; 4. No available PD-L1 test results at diagnosis; 5. Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastasis (stage IV); 6. History of any active malignancy within the past 2 years, except for specific cancers or those with local recurrence after radical treatment (e.g., resected basal cell or squamous cell skin cancers, superficial bladder cancer, in situ cervical or breast cancers); 7. History of any condition requiring systemic treatment with corticosteroids (prednisone or equivalent >10 mg/day) or other immunosuppressive drugs; 8. History of interstitial lung disease, non-infectious pneumonia, or poorly controlled conditions, including pulmonary fibrosis and acute lung disease; 9. Presence of any severe and/or uncontrolled comorbid conditions, including: a. Poorly controlled hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg); b. Myocardial ischemia or infarction of grade I or higher, arrhythmias (including QT interval >= 440 ms), and congestive heart failure of grade >= 2 (NYHA classification); c. Active or uncontrolled severe infection ( >= CTC AE grade 2 infection); d. Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment; e. Renal failure requiring hemodialysis or peritoneal dialysis; f. History of immune deficiency, including HIV-positive status or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; g. Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); h. Urinary protein >= ++ on urinalysis, confirmed by 24-hour urinary protein quantification >1.0 g; i. Patients with epilepsy requiring treatment or those with a history of venous thromboembolic events within the last 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism; 10. Any concomitant disease, as judged by the investigator, that poses a severe risk to patient safety or hinders completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response; Pathologic Complete Response;Tumor Proportion Score; | — |
Countries
China
Contacts
Public ContactRunbo Zhong
Shanghai Chest Hospital
Outcome results
None listed