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Trial Title:
Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
NCT ID:
NCT05775796
Condition:
Non-small Cell Lung Cancer
Stage II-IIIA
Immunotherapy
Neoadjuvant Therapy
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab and Chemotherapy
Description:
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Arm group label:
Serplulimab plus platinum doublet chemotherapy
Summary:
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).
Criteria for eligibility:
Criteria:
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.
- Participants with 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Fangqiu Fu, M.D.
Phone:
021-64175590
Email:
fufangqiu12@163.com
Start date:
March 15, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775796
