NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 3, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

June 1, 2035

Conditions

High Grade GliomaDiffuse Intrinsic Pontine GliomaAnaplastic AstrocytomaInfant Type Hemispheric GliomaGlioblastomaGlioblastoma MultiformeWHO Grade III GliomaWHO Grade IV GliomaDiffuse Midline Glioma, H3K27-altered

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

Trial Locations (17)

2031

Sydney Children's Hospital, Randwick

3720

Princess Máxima Center, Utrecht

4101

Queensland Children's Hospital, South Brisbane

6000

Perth Children's Hospital, Perth

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

27708

Duke University Health System, Durham

43235

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

69120

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), Heidelberg

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

98105

Seattle Children's Hospital, Seattle

02215

Dana-Farber Cancer Institute, Boston

M5G1X8

The Hospital for Sick Children (SickKids), Toronto

H4A3J1

Montreal Children's Hospital, Montreal