NCT05775796CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 7 Mar 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 28 May 2024
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT05775796
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 15 Mar 2023 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- Other protocol defined inclusion/exclusion criteria apply
Other illness
- Presence of locally advanced, inoperable or metastatic disease.
- Active, known or suspected autoimmune disease.
Lab values
- Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis.J Immunother Cancer · 2026 · PMID 42114951
This page is information, not medical advice. Discuss any trial with your doctor.