Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Previous anti-tumor therapy for the disease.
• Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.
• Any serious active infection.
• With uncontrolled or significant cardiovascular and cerebrovascular disease.
• Active autoimmune disease requiring systemic treatment.
• Immunosuppressant or systemic hormone therapy (dose \>10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.