RecruitingPhase 2

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

China116 participantsStarted 2026-02-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years and ≤ 75 years at time of study entry.
✓. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology.
✓. The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology;
✓. Able to tolerate complete lung cancer resection;
✓. WHO/ECOG performance status of 0 or 1.

Exclusion criteria

✕. Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma.
✕. EGFR sensitivity mutation or ALK, ROS1 gene rearrangement;
✕. Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs;
✕. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology

What they're measuring

Pathological complete remission (PCR) rate

Timeframe: From randomization up to a median of 30 months after randomization

Trial details

NCT IDNCT07398937

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Resectable Stage II-IIIa Squamous NSCLC trials