Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
NCT06333899 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Lorlatinib
- DRUG Lorlatinib with chemotherapy1
- DRUG Lorlatinib with chemotherapy 2
- DRUG Lorlatinib post Radiation
Study Locations (18)
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Nationwide Children's Hospital — Columbus
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Massachusetts
- Dana-Farber Cancer Institute — Boston
North Carolina
- Duke University Health System — Durham
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Texas
- Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-03 |
| Est. Completion | 2035-06-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06333899
The ClinicalTrials.gov registry entry for NCT06333899 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions — of which Lorlatinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06333899 reports 18 study locations spanning 17 distinct geographic areas — top geographies include Ohio, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06333899 about?
NCT06333899 is a clinical study titled "Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion". 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.
What is the current status of trial NCT06333899?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2025-08-03. Estimated completion is 2035-06-01.
What conditions does trial NCT06333899 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, High Grade Glioma, Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06333899?
The interventions under investigation include: Lorlatinib (DRUG), Lorlatinib with chemotherapy1 (DRUG), Lorlatinib with chemotherapy 2 (DRUG), Lorlatinib post Radiation (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06333899?
This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06333899 being conducted?
This trial has 18 study locations across Colorado, District of Columbia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.