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

Fudan University

Status and phase

Completed

Phase 2

Conditions

Immunotherapy

Non-small Cell Lung Cancer

Neoadjuvant Therapy

Stage II-IIIA

Treatments

Drug: Serplulimab and Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05775796

HLX10IIT21

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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