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

NCT05775796 | Completed Phase 2

• 1 other identifier: HLX10IIT21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.

Conditions

Non-small Cell Lung Cancer; Stage II-IIIA; Immunotherapy; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of Pathologic Complete Response (pCR)

  Up to 6 months

• Rate of R0 resection

  Up to 6 months

• Objective remission rate(ORR)

  Up to 6 months

• Event-Free Survival (EFS)

  2 years

• Immune infiltrations in tumor-draining lymph nodes

  2 years

Study Arms (1)

Serplulimab plus platinum doublet chemotherapy

EXPERIMENTAL

Drug: Serplulimab and Chemotherapy

Interventions

Serplulimab and Chemotherapy DRUG

Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin

Serplulimab plus platinum doublet chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thoracic Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 15, 2023
• Primary Completion: May 28, 2024
• Study Completion: September 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)