Clinical Trial

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Recruiting Early Phase 1
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Summary
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-03-20; most recent amendment 2026-06-25.
Status change: Active, Not Recruiting → Recruiting 2026-03-10
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-09-11
Trial Details
NCT Number NCT06333899
Lead Sponsor Nationwide Children's Hospital
Collaborators: Pfizer
Conditions High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma, Glioblastoma, Glioblastoma Multiforme, WHO Grade III Glioma, WHO Grade IV Glioma +1 more
Enrollment 15 participants
Start Date 2025-08-03
Primary Completion 2029-07-01 (estimated)
Study Completion 2035-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-29