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

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 proposedpneumonectomy procedure.

Exclusion Criteria:

1. Tumor histologically or cytologically confirmed or combined with neuroendocrinecarcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamouscarcinoma, or special pathological types.

2. Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4,OX-40, etc.);

3. Participants with known EGFR mutation or ALK translocation, and non-squamous cellcarcinoma subjects need to identify EGFR and ALK mutation status;

4. Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.

5. Previous anti-tumor therapy for the disease.

6. Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or othermoderate to severe lung disease that may interfere with the detection or managementof drug-related pulmonary toxicity and seriously affect respiratory function.

7. Any serious active infection.

8. With uncontrolled or significant cardiovascular and cerebrovascular disease.

9. Active autoimmune disease requiring systemic treatment.

10. Immunosuppressant or systemic hormone therapy (dose >10 mg/ day prednisone or othertherapeutic hormone) for immunosuppression within 14 days prior to randomization.