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

Phase 2

Recruiting

• Conditions: Stage II-IIIA; Neoadjuvant Therapy; Non-small Cell Lung Cancer; Immunotherapy
• Interventions: Drug: Serplulimab and Chemotherapy

• Registration Number: NCT05775796
• Lead Sponsor: Fudan University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study Start: 2023-03-15
• Study First Posted: 2023-03-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-02-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serplulimab plus platinum doublet chemotherapy	Serplulimab and Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Major Pathologic Response (MPR) Rate	From start of treatment to 6 months	Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes

Secondary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR) Rate	From start of treatment to 6 months	Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy
R0 resection rate	From start of treatment to 6 months	The complete resection rate is the proportion of patients with complete resection
Objective remission rate(ORR)	approximately up to 12 months	Objective response rate according to RECIST 1.1
Event-Free Survival (EFS)	From enrollment to disease progression, reoccurrence, or death due to any cause.(Up to a median of 22 months)	Event-free survival (EFS) is defined as the length of time from enrollment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China