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Completed

NCT Number: NCT05775796

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Immunotherapy Lung Diseases Lung Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage II-IIIA Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serplulimab and Chemotherapy

Drug

Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin

Primary outcomes

  1. Rate of Major Pathologic Response (MPR)

    Time frame: Up to 6 months

    Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes

Secondary outcomes

  1. Rate of Pathologic Complete Response (pCR)

    Time frame: Up to 6 months

    Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy

  2. Rate of R0 resection

    Time frame: Up to 6 months

    The complete resection rate is the proportion of patients with complete resection

  3. Objective remission rate(ORR)

    Time frame: Up to 6 months

    Objective response rate according to RECIST 1.1

  4. Event-Free Survival (EFS)

    Time frame: 2 years

    Event-free survival (EFS) is defined as the length of time from enrollment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Patients who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.

  5. Immune infiltrations in tumor-draining lymph nodes

    Time frame: 2 years

    Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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