Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Trial Parameters
Brief Summary
This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.
Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate and sign the informed consent form. 2. Age ≥ 18 years old, regardless of gender. 3. Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC. 4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Subjects should provide tumor tissue for detection of PD-L1 expression level. 7. Sufficient organ and bone marrow function. 8. Expected survival ≥6 months. 9. The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure. Exclusion Criteria: 1. Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types. 2. Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.); 3. Particip