Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC
Recruiting · NCT07398937 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
Nivolumab + chemotherapySerplulimab + chemotherapy
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China