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.
Fudan University
116 participants
Feb 5, 2026
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
Inclusion Criteria5
- 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 Criteria4
- 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
Interventions
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 \[360 mg, administered on Day 1, Q3W (once every 3 weeks)\] + 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07398937