IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Trial Parameters
Brief Summary
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Eligibility Criteria
Inclusion Criteria: 1. Males and Females, age ≥18 years and ≤75 years; 2. Histologically or cytologically confirmed primary non-squamous NSCLC: * Stage IB, 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. 3. Participants without EGFR mutations or ALK translocation; 4. At least 1 measurable lesion per RECISIT v1.1; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1; 6. Adequate organ function confirmed at screening period. Exclusion Criteria: 1. 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; 2. Tumor invasion of surrounding important structures, which is symptomatic or medical i