Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
- Sponsor
- Fudan University
- Study ID
- NCT05775796
- Phase
- PHASE2
- Status
- Completed
Conditions
- Immunotherapy
- Neoadjuvant Therapy
- Non-small Cell Lung Cancer
- Stage II-IIIA
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Serplulimab and Chemotherapy — DRUGSerplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Study Details
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.
Key Dates
- Start date
- Mar 15, 2023
- Status verified
- Sep 2025
- Primary completion
- May 28, 2024
- Completion
- Sep 1, 2025
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Serplulimab plus platinum doublet chemotherapy
Primary Outcome Measure
Rate of Major Pathologic Response (MPR) [ Time Frame: Up to 6 months ]
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