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

A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Neoadjuvant Therapy; Immunotherapy; Stage II-IIIA
• Intervention / Treatment: Drug: Serplulimab and Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Other protocol defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serplulimab plus platinum doublet chemotherapy	Drug: Serplulimab and Chemotherapy; Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Pathologic Response (MPR)	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	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Pathologic Complete Response (pCR)	Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy	Up to 6 months
Rate of R0 resection	The complete resection rate is the proportion of patients with complete resection	Up to 6 months
Objective remission rate(ORR)	Objective response rate according to RECIST 1.1	Up to 6 months
Event-Free Survival (EFS)	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. Patients who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.	2 years
Immune infiltrations in tumor-draining lymph nodes	Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing	2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Drug Therapy
• Other Study ID Numbers: HLX10IIT21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No