A Study to Prospectively Validate Blood Markers Associated With Differences in Efficacy of Neoadjuvant Therapy for NSCLC

Exclusion Criteria

• •1. Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components
• •2. Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body
• •3. pulmonary sulcus tumor
• •4. Contralateral lung nodules, it need biopsy if clinically suspected
• •5. Subjects with confirmed or suspected brain metastases
• •6. Participation in an interventional clinical study or treatment with another investigational drug or investigational device within 4 weeks prior to enrollment
• •7. Previous use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy
• •8. Received immunomodulatory drugs (including thymidine, interferon, interleukins, etc.) within the first 4 weeks of enrollment
• •9. Live attenuated vaccine within the first 4 weeks of enrollment (or plan to receive live attenuated vaccine during the study period). Note: Inactivated seasonal influenza vaccine is permitted, but live attenuated influenza vaccine is not permitted
• •10. Requires prolonged systemic glucocorticoid use and has received any other form of immunosuppressive therapy within 7 days prior to enrollment Note: Nasal spray, inhalation, or other topical glucocorticoid or physiologic doses of systemic glucocorticoid (≤ 10 mg/day of prednisone or equivalent) are permitted or are used for pretreatment (e.g., for prevention of contrast allergy).
• •11. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to enrollment or current interstitial lung disease (≥ grade 2)
• •12. Active autoimmune disease including, but not limited to, inflammatory bowel disease such as ulcerative colitis or Crohn's disease requiring systemic therapy (e.g., use of disease modifying medications, corticosteroids, or immunosuppressive drugs) within the 2 years prior to enrollment Diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis-like or Wegener's syndrome (granulomatous polyangiitis), Graves' disease, rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis, antiphospholipid syndrome, pituitary gland inflammation, and uveitis. Replacement therapies (e.g., thyroxine, insulin, or physiologic doses of corticosteroids for adrenal or pituitary dysfunction) are not considered systemic therapy. Patients with positive autoimmune antibodies will be enrolled only after evaluation by the investigator to confirm that there are no autoimmune diseases requiring systemic therapy.
• •13. Primary immunodeficiency diseases
• •14. Pre-existing or current myocarditis
• •15. incomplete recovery from toxicity and/or complications resulting from any intervention prior to enrollment (\> grade 1 or not recovered to baseline levels)
• •16. Peripheral neuropathy ≥ grade 2
• •17. Hereditary predisposition to bleeding or coagulation disorders, or history of thrombosis: Any arterial thrombosis, embolism, or ischemia such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6 months prior to enrollment. History of deep vein thrombosis or any other serious thromboembolism within 3 months prior to enrollment (implantable venous access ports or catheter-derived thrombosis or superficial vein thrombosis are not considered thromboembolism).
• •18. Subjects with non-squamous NSCLC who are unable or unwilling to supplement with folic acid or vitamin B12
• •19. Any unstable systemic disease or complication, including but not limited to 1) active infection (requiring anti-infective medications or systemic anti-infective medications within one week prior to randomization); 2) congestive heart failure \[New York Heart Association, NYHA ≥ Class II\]; 3) severe cardiac arrhythmia, hepatic, renal, or metabolic disorders requiring medication; 4) untreated atherosclerotic heart disease of the coronary arteries; 5) history of gastrointestinal perforation and/or fistulae (5) History of gastrointestinal perforation and/or fistula; (6) History of intestinal obstruction, extensive bowel resection or chronic diarrhea within the past 6 months.
• •20. Solid organ or blood system transplantation.
• •21. Have a history of HIV infection (HIV1/2 antibody positive), active syphilis
• •22. Tuberculosis, which is active or requires medical intervention at this stage, including but not limited to pulmonary tuberculosis