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.
Parallel
Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
DrugThe subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.
placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection
DrugThe subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.
MPR by BIPR
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy (evaluated by BIPR)
EFS by BIRC
EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.
pCR
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy, assessed by BIPR;
DFS
DFS is defined as the time from post-surgery to radiographic disease progression, local or distant recurrence, or death from any cause, assessed by BIRC;
OS
OS is defined as the time from randomization until death from any cause.;
EFS
EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression or recurrence/metastasis, or death from any cause., assessed by investigator;
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