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RECRUITING
NCT06926790
PHASE2

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

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