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

NCT07398937 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-02-10

No results posted yet for this study

Summary

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

  • Resectable Stage II-IIIa Squamous NSCLC

Interventions

DRUG

Serplulimab + chemotherapy

Serplulimab injection \[300 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles

DRUG

Nivolumab + chemotherapy

Nivolumab \[360 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398937 on ClinicalTrials.gov