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

RecruitingPhase 2Ages 18 Years - 75 YearsAllFudan University
NCT07398937 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years at time of study entry. 2. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology. 3. The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology; 4. Able to tolerate complete lung cancer resection; 5. WHO/ECOG performance status of 0 or 1. Exclusion Criteria: 1. 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. 2. EGFR sensitivity mutation or ALK, ROS1 gene rearrangement; 3. Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs; 4. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
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What it tests

  • Serplulimab + chemotherapy
  • Nivolumab + chemotherapy
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Where

1 site
Fudan University Shanghai Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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