Actively Recruiting
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2025-04-22
69
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- At least 18 years old
- Histologically or cytologically confirmed non-small cell lung cancer without EGFR or ALK mutations
- Clinical stage II to IIIA with measurable disease and PD-L1 expression less than or equal to 1% or unknown
- Disease suitable for surgery
- No previous systemic therapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion
- No major dysfunction of liver, kidney, or heart
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease
- Previous treatment for non-small cell lung cancer or any other cancer
- Allergy to components of the study drugs
- Pregnant or breastfeeding
- Mental or psychological conditions preventing study completion or understanding
- Presence of other malignancies
- Major surgery or serious injury within the past 3 months
- HIV, HBV, HCV infections or active pulmonary tuberculosis
- Vaccination within 4 weeks before study start
- Underlying medical conditions that increase risk or interfere with safety assessment as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120
Actively Recruiting
Research Team
S
Shuben Li, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here