Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)

A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.

Inclusion Criteria:

• stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
• Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
• Eligible male and female subjects aged 18-75 years.
• Lung function capacity capable of tolerating the proposed lung surgery.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Available tissue of primary lung tumor.

Exclusion Criteria:

• Presence of locally advanced, inoperable or metastatic disease.
• Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
• Active, known or suspected autoimmune disease.
• Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).

Other protocol defined inclusion/exclusion criteria apply