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

NCT ID: NCT05775796

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage II-IIIA Immunotherapy Neoadjuvant Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serplulimab plus platinum doublet chemotherapy

Group Type EXPERIMENTAL

Serplulimab and Chemotherapy

Intervention Type DRUG

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

Interventions

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Serplulimab and Chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haiquan Chen

Director of Thoracic Surgery, Fudan University Shanghai Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HLX10IIT21

Identifier Type: -

Identifier Source: org_study_id

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