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Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

Study acronym: GALAXY 3
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Interventions: Ipilimumab - 1 mg/kg (Drug), nivolumab (Drug) to Nivolumab & Ipilimumab (Drug)
    • Secondary endpoints: 6 to 10
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06926790
Lead Sponsor The First Affiliated Hospital of Guangzhou Medical University
Conditions
(from sponsor)		 Lung Cancer - Non Small Cell
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov