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Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC
Sponsor: Fudan University
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.
Official 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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-02-05
Completion Date
2029-12-31
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Serplulimab + 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
Nivolumab + 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