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

NCT06333899 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-12

No results posted yet for this 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

Interventions

DRUG

Lorlatinib

Continue maintenance monotherapy for total 12 cycles

DRUG

Lorlatinib with chemotherapy1

Continue lorlatinib with BABY-POG chemotherapy backbone for 72 weeks

DRUG

Lorlatinib with chemotherapy 2

Continue lorlatinib with HIT-SKK chemotherapy backbone for 42 weeks

DRUG

Lorlatinib post Radiation

Continue lorlatinib monotherapy 28 days post completion of radiation therapy for 12 cycles

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Hamza Gorsi, MD · Children's Hospital of Michigan

  • Susan Chi, MD · Dana-Farber Cancer Institute

  • Maryam Fouladi, MD · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-03
Primary Completion
2029-07-01
Completion
2035-06-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Netherlands
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333899 on ClinicalTrials.gov