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）.
Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.