IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

Prior treatment

• Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
• Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
• Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug;
• History of immunodeficiency disease; 12 Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.

Other illness

• Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
• Malignant tumor nodule in the contralateral lung lobe;
• History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or severe impairment of pulmonary function or who are suspected to have these diseases by imaging during the screening period;
• Active or uncontrolled diseases or conditions;

Other

• Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
• Pancoast tumor;
• Participants with known or suspected brain metastases or other distant metastases;

• Males and Females, age ≥18 years and ≤75 years;
• Histologically or cytologically confirmed primary NSCLC:
  • Stage II, IIIA or IIIB (N2) NSCLC (per AJCC8);
  • No administration of any anti-NSCLC therapy in the pre-operative period;
  • Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
• Participants without EGFR mutations or ALK translocation;
• PD-L1 expression: TPS≥1%
• At least 1 measurable lesion per RECISIT v1.1;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• Adequate organ function confirmed at screening period.