DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Running, not enrolling · Phase 3

Conditions studied: Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, Pediatric Low-grade Glioma

In brief

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.

Key facts

Study ID

NCT05566795

Run by

Day One Biopharmaceuticals, Inc.

People needed

418

Starts

2023-02-27

Expected to finish

2031-06-01

Last updated by the study team

2026-05-14

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than 25 years of age with LGG with known activating RAF alteration.
• Histopathologic diagnosis of glioma or glioneuronal tumor.
• At least one measurable lesion as defined by RANO criteria.
• Meet indication for first-line systemic therapy.

You may not qualify if…

• Participant has any of the following tumor-histological findings:
• Schwannoma
• Subependymal giant cell astrocytoma (Tuberous Sclerosis)
• Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
• Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
• Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
• Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County Main Campus - Orange — Orange, California, United States
• Packard Children's Hospital Stanford — Palo Alto, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Health — Gainesville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Institut Curie — Paris, France
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• University of Iowa Hospitals Clinics — Iowa City, Iowa, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Maine Children's Cancer Program — Scarborough, Maine, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan - - C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Minnesota — Minneapolis, Minnesota, United States
• Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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