A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC

Exclusion Criteria

• •1. Patients with large cell neuroendocrine carcinoma (LCNEC) or NSCLC mixed with small cell lung cancer components;
• •2. Presence of locally advanced unresectable disease (any stage) or metastatic disease (Stage IV). Subjects with contralateral mediastinal lymph node involvement confirmed by PET-CT scan.
• •3. NSCLC diagnosed with EGFR-sensitive mutations or ALK gene translocation. For non-squamous cell carcinoma subjects (including NSCLC with unclear pathology), tumor tissue-based EGFR and ALK testing results must be provided. If EGFR/ALK status is unknown, testing must be performed prior to enrollment. For squamous NSCLC subjects, EGFR/ALK testing is not required during screening if status is unknown.
• •4. Any prior systemic or local anti-tumor therapy for NSCLC;
• •5. Concurrent enrollment in another clinical trial;
• •6. History of other malignancies (excluding NSCLC) within 3 years prior to randomization;
• •7. Active autoimmune disease requiring systemic treatment within 2 years prior to randomization;
• •8. History of major diseases within 1 year prior to randomization;
• •9. Severe cardiovascular risk factors;
• •10. History of significant bleeding diathesis or coagulation disorders; clinically significant bleeding symptoms (including but not limited to gastrointestinal hemorrhage, hemoptysis ≥1 teaspoon of fresh blood/clots or pure hemoptysis without sputum, minor blood-tinged sputum allowed; excluding epistaxis and retracted blood-tinged nasal discharge) within 4 weeks prior to randomization;
• •11. Any other conditions deemed unsuitable for enrollment by the investigator.