Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Study ID
NCT06926790
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer - Non Small Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab & Ipilimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
69 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant treatment
    Patients with IIA-IIIB NSCLC will received 2-3 cycles of neoadjuvant Nivolumab (3 mg/kg intravenously (i.v.), every 3 week) plus Ipilimumab (1 mg/kg i.v., every 6 week). Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After the second cycles treatment, contrast-enhanced chest CT will be performed to evaluate the tumor.

Primary Outcome Measure

Pathological Complete Response (PCR) [ Time Frame: Within 2 weeks after surgery ]

Central Contacts

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