Clinical Trial

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Recruiting Phase 3
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Summary
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Protocol Amendment History 69 amendments
This ClinicalTrials.gov record has been amended 69 times since 2017-04-24; most recent amendment 2026-02-24.
Status change: Active, Not Recruiting → Recruiting 2025-09-30
Status change: Recruiting → Active, Not Recruiting 2023-10-02
Status change: Active, Not Recruiting → Recruiting 2021-03-05
Status change: Recruiting → Active, Not Recruiting 2020-12-30
Status change: Not Yet Recruiting → Recruiting 2018-05-25
Trial Details
NCT Number NCT03126916
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
Enrollment 750 participants
Start Date 2018-05-14
Primary Completion 2030-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-27