Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

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.

• Participants with 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