OncoMatch/Clinical Trials/NCT06333899
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
Is NCT06333899 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Lorlatinib and Lorlatinib with chemotherapy1 for high grade glioma.
Treatment: Lorlatinib · Lorlatinib with chemotherapy1 · Lorlatinib with chemotherapy 2 · Lorlatinib post Radiation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: ALK fusion
Required: ROS1 fusion
Disease stage
Required: Stage WHO GRADE 3, WHO GRADE 4, DIFFUSE WHO GRADE 2-4 (FOR DIPG) (WHO)
All other HGGs must be Grade 3 or 4. 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.
Prior therapy
Cannot have received: anti-cancer chemotherapy
Patients must not have received any prior anti-cancer chemotherapy.
Cannot have received: investigational agent
Patients who have previously received or are currently receiving another investigational drug are not eligible.
Cannot have received: immunotherapy
Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible
Cannot have received: monoclonal antibody
Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible
Cannot have received: biologic or targeted therapy
Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 1000/μL; Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment); Hemoglobin >8 g/dL (may receive transfusions)
Kidney function
Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
Liver function
Total bilirubin ≤ 2 × institutional upper limit of normal; AST/ALT ≤ 2.5 × institutional upper limit of normal
Cardiac function
QTc ≤ 470 msec (by Bazett formula)
Adequate Bone Marrow Function...Adequate Renal Function...Adequate Liver Function...Adequate Pulmonary Function...Adequate Cardiac Function...Adequate Neurologic Function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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