The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer

Inclusion criteria

• Age 18 to 75 years old, gender is not limited.
• ECOG performance status 0-1.
• non-small cell lung cancer diagnosed by pathology.
• sufficient tumor tissue available for biomarker analysis.
• clinical staging of cT1-2N1-2M0 or T3N1M0, stage II-IIIA (8th UICC staging criteria).
• Patients with distant metastases ruled out by CT or PET/CT and physically assessed as acceptable for radical lung cancer surgery.
• histomolecular pathology confirming the absence of classic driver oncogene mutations in EGFR, ALK, or ROS1.
• Basic normal function of all organs (laboratory test results within 1 week prior to enrollment).
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5x109 /L, platelet count ≥ 100x109 /L, hemoglobin ≥ 9g/dL.
• Liver: serum total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal.
• Kidney: blood creatinine level ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L.
• Urine protein \<+, if urine protein + then total 24 hour protein must be \<500mg.
• Blood glucose: within normal range and/or with diabetic patients on treatment but with stable blood glucose control.
• Pulmonary function: baseline FEV1 of at least 2L; if baseline FEV1 \< 2L then FEV1 \> 800ml is expected after surgery as assessed by a surgical specialist.
• Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency.
• Voluntarily participated in this study and signed the informed consent form by himself or his agent

Exclusion criteria

• Pathology suggestive of compound small cell lung cancer, etc.
• History of previous lobectomy, radiotherapy or chemotherapy.
• Those with concurrent second primary carcinoma and a history of previous malignancy of less than 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous epithelial cell skin cancer).
• Patients with any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.).
• Have an active infection requiring systemic treatment or a history of active tuberculosis.
• Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
• Those with known presence or coexistence of other uncontrollable diseases that are not amenable to surgical treatment
• Physical examination or clinical trial finds that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk for treatment complications
• Prior interstitial lung disease, drug-induced interstitial disease or any clinically evident active interstitial lung disease with idiopathic pulmonary fibrosis on baseline CT scan; uncontrolled massive pleural or pericardial effusion
• Unstable systemic concomitant disease (active infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertensive disease, unstable angina pectoris, congestive heart failure, myocardial infarction occurring within 6 months, severe mental disorder requiring medication for control, liver, renal or other metabolic disease, neuropsychiatric pathology such as Alzheimer's disease)
• History of congenital or acquired immunodeficiency disorders or organ transplantation
• Received any of the following treatments:
• Prior radiotherapy, treatment with anti PD-1, anti PD-L1 or anti PD-L2 drugs, or other drugs that synergistically inhibit T-cell receptors such as CTLA-4, OX-40, CD137.
• Having received any investigational drug within 4 weeks
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up
• Persons who have received an antineoplastic vaccine or who have received a live vaccine within 4 weeks
• Have undergone major surgery or had severe trauma within 4 weeks