A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer
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.
• Volunteer to participate and sign the informed consent form.
• Age ≥ 18 years old, regardless of gender.
• Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.
• Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Subjects should provide tumor tissue for detection of PD-L1 expression level.
• Sufficient organ and bone marrow function.
• Expected survival ≥6 months.
• The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.