Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07398937

Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC

Led by Fudan University · Updated on 2026-02-10

116

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.

CONDITIONS

Official Title

Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years at study entry
  • Histopathologically or cytologically confirmed stage II to IIIa squamous non-small cell lung cancer
  • Able to tolerate complete lung cancer surgery
  • WHO/ECOG performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Presence of non-squamous NSCLC types such as adenocarcinoma, mixed squamous-adenocarcinoma, or NSCLC with small cell or neuroendocrine components
  • Presence of EGFR sensitivity mutations or ALK, ROS1 gene rearrangements
  • Known severe allergy to carboplatin, albumin-bound paclitaxel, or other study drugs
  • Central nervous system or leptomeningeal metastases confirmed by imaging or pathology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC | DecenTrialz