CompletedPhase 2

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

China30 participantsStarted 2023-03-15

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Rate of Major Pathologic Response (MPR)

Timeframe: Up to 6 months

Trial details

NCT IDNCT05775796

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-28

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