🏛️ Verified NIH Record • Updated 2026-06-25

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion (NCT06333899)

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Nationwide Children's Hospital

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Children's Hospital Colorado — Aurora, Colorado

Age range: 1 Year to 21 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (18 Sites)

  • Children's Hospital Colorado — Aurora, Colorado
  • Children's National Medical Center — Washington D.C., District of Columbia
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • Duke University Health System — Durham, North Carolina
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
  • Nationwide Children's Hospital — Columbus, Ohio
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
  • Texas Children's Hospital — Houston, Texas
  • Seattle Children's Hospital — Seattle, Washington
  • Sydney Children's Hospital — Randwick, New South Wales
  • Queensland Children's Hospital — South Brisbane, Queensland
  • Perth Children's Hospital — Perth, Western Australia
  • The Hospital for Sick Children (SickKids) — Toronto, Ontario
  • Montreal Children's Hospital — Montreal, Quebec
  • Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) — Heidelberg, Baden-Wurttemberg
  • Princess Máxima Center — Utrecht,
  • Starship Children's Hospital — Auckland, Grafton

📞 Contact the Study Coordinator

Phone: (614) 722-3284

Email: kelsey.troyer@nationwidechildrens.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗