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Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, conventional chemotherapy components may increase treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1 expression \<1% remains to be improved. Emerging evidence has demonstrated that the combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) provides superior responses in the treatment of advanced NSCLC. However, the safety and efficacy of this strategy in the neoadjuvant setting remain controversial. Therefore, this single-arm clinical trial aims to evaluate the safety and feasibility of neoadjuvant nivolumab plus ipilimumab followed by surgery in treating locally advanced and resectable NSCLC.
Official title: Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2025-02-17
Completion Date
2030-10-31
Last Updated
2025-04-22
Healthy Volunteers
No
Conditions
Interventions
Nivolumab & Ipilimumab
This study evaluates the safety and efficacy of neoadjuvant nivolumab plus ipilimumab for IIA-IIIB NSCLC. Based on preliminary trial results, this study proposes a new treatment regimen.
Locations (1)
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China