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

🧪 Interventions in This Study

• Lorlatinib (DRUG)
• Lorlatinib with chemotherapy1 (DRUG)
• Lorlatinib with chemotherapy 2 (DRUG)
• Lorlatinib post Radiation (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.
2. Diagnosis: Patients with newly diagnosed high-grade glioma (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors harbor an ALK or ROS-1 fusion alteration are eligible. Patients must have had histologically verified high-grade glioma from diagnostic biopsy or resection. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4. All other HGGs must be Grade 3 or 4.
3. Disease Status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated disease is suspected clinically by the treating physicians. Patients with primary spinal tumors are eligible only if the patient is to receive either chemotherapy or focal radiation therapy, i.e., no craniospinal RT is intended to be given. Patients with leptomeningeal disease only, with no definitive identifiable primary tumor, and documented ALK or ROS-1 fusion, must be discussed with the Study Chair on a case-by-case basis.
4. Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
5. Prior Therapy:
6. Patients must not have received any prior anti-cancer chemotherapy.
7. Prior use of corticosteroids is allowed (see below Exclusion Criteria)
8. Organ Function Requirements 6.1 Adequate Bone Marrow Function Defined as:
9. Peripheral absolute neutrophil count (ANC) ≥ 1000/μL
10. Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
11. Hemoglobin \>8 g/dL (may receive transfusions) 6.2 Adequate Renal Function Defined as:
12. Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 6.3 Adequate Liver Function Defined as:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.

More studies in High Grade Glioma

• PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma — Aurora, Colorado
• Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors — Aurora, Colorado
• MRI in High-Grade Glioma Patients Undergoing Chemoradiation — Winston-Salem, North Carolina
• A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion — Aurora, Colorado
• A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG) — Toronto, Ontario

Explore by condition: All High Grade Glioma clinical trials

💡 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.