Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer

Inclusion Criteria

• •Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits;
• •Aged 18-75 years, regardless of gender;
• •ECOG performance status score of 0-1;
• •Expected survival time ≥ 3 months;
• •\- Pathologically/radiologically confirmed stage II-III NSCLC (AJCC 9th Edition). For adenocarcinoma/adenosquamous carcinoma, EGFR wild-type and ALK fusion-negative required before enrollment;
• •No prior systemic anti-tumor therapy;
• •At least one measurable lesion per RECIST 1.1. Previously irradiated lesions are measurable if progression is confirmed;
• •Adequate organ function, as evidenced by meeting the following laboratory parameters:
• •1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L without administration of granulocyte colony-stimulating factor within the past 14 days;
• •2. Platelet count ≥ 80 × 10⁹/L without blood transfusion within the past 14 days;
• •3. Hemoglobin \> 8 g/dL without blood transfusion or erythropoietin administration within the past 14 days;
• •4. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);
• •5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable);
• •6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min;
• •7. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;
• •8. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \[FT3\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment;
• •9. Myocardial enzyme profile within the normal range;
• •Females of childbearing potential: negative pregnancy test (urine/serum) within 3 days pre-first dose (Cycle 1 Day 1); serum test required if urine test unconfirmed. Non-childbearing females: postmenopausal ≥ 1 year, surgically sterile or hysterectomized;
• •Subjects at risk of conception: use contraception with annual failure rate \< 1% during treatment and 120-180 days post-last dose;
• •Prior allogeneic organ transplantation (except corneal) or hematopoietic stem cell transplantation;
• •Inadequate recovery from prior intervention toxicities/complications (not resolved to Grade ≤ 1 or baseline, excluding fatigue/alopecia);
• •Known HIV infection (HIV 1/2 antibody positive);
• •Other conditions deemed unsuitable by investigator;