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NCT Number: NCT07398937

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

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.

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Key information

Conditions

Resectable Stage II-IIIa Squamous NSCLC Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Fangqiu Fu

CONTACT

[email protected]

021-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serplulimab + chemotherapy

Drug

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

Nivolumab + chemotherapy

Drug

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;

Primary outcomes

  1. Pathological complete remission (PCR) rate

    Time frame: From randomization up to a median of 30 months after randomization

    Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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.

Acronym: ECTOP-1036

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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