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
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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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2023-03-15
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Serplulimab plus platinum doublet chemotherapy
Serplulimab and Chemotherapy
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Interventions
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Serplulimab and Chemotherapy
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Haiquan Chen
Director of Thoracic Surgery, Fudan University Shanghai Cancer Center
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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HLX10IIT21
Identifier Type: -
Identifier Source: org_study_id
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