A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

Inclusion Criteria

• •1. Signed written informed consent form
• •2. Age: 18-75 years.
• •3. Cytologically/histologically confirmed (via percutaneous lung puncture, bronchoscopy, mediastinoscopy, etc.), previously untreated stage II-IIIB (IASLC 8th Edition Thoracic Tumor Classification) lung adenocarcinoma.
• •4. Tumor tissue or blood samples confirmed as EGFR-sensitive or rare mutation-positive by laboratory testing
• •5. Must provide archived tumor tissue or newly resected tumor biopsy samples for PD-L1 IHC testing during screening.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• •7. Measurable lesions per RECIST v1.1.
• •8. Surgically evaluated as eligible for local surgical resection (adequate pulmonary/organ function).Surgically evaluated as eligible for local surgical resection (adequate pulmonary/organ function).
• •9. Adequate organ and bone marrow function (within 7 days prior to enrollment; no corrective therapies within 14 days prior to testing): • Hematology: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥100 g/L. • Hepatic: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN; albumin ≥35 g/L. • Renal: Serum creatinine ≤1.5×ULN; CrCl ≥60 mL/min (Cockcroft-Gault formula); urine protein \<2+ or 24-hour urine protein \<1 g. Cockcroft-Gault formula: • Female: CrCl = \[(140 - age) × weight (kg) × 0.85\] / \[72 × serum creatinine (mg/dL)\]. • Male: CrCl = \[(140 - age) × weight (kg)\] / \[72 × serum creatinine (mg/dL)\]. • Coagulation: INR ≤1.5×ULN; PT/APTT ≤1.5×ULN.
• •10. For women of childbearing potential: Negative urine/serum pregnancy test within 7 days prior to first dose. Confirmatory blood test required if urine test is positive.