RecruitingPhase 2NCT07398937

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

A Randomized, Open-label, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Serplulimab Combined With Chemotherapy Versus Nivolumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIa Squamous NSCLC.


Sponsor

Fudan University

Enrollment

116 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two immunotherapy drugs — serplulimab versus nivolumab — both combined with chemotherapy, as pre-surgery treatment (neoadjuvant therapy) for patients with resectable Stage II or IIIA squamous non-small cell lung cancer. The goal is to shrink the tumor before surgery and see which combination works better. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with Stage II or IIIA squamous non-small cell lung cancer confirmed by biopsy - Your cancer is considered removable by surgery - You are in good enough health to undergo lung cancer surgery **You may NOT be eligible if...** - Your cancer has already spread beyond the chest or is Stage IIIB or higher - You have active autoimmune disease requiring treatment - You have had serious prior lung conditions or interstitial lung disease - You are pregnant or breastfeeding - You have previously received immunotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSerplulimab + 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

DRUGNivolumab + 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;


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07398937