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Comparing tovorafenib to standard chemotherapy for pediatric low-grade glioma

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

PHASE3 · Day One Biopharmaceuticals, Inc. · NCT05566795

This study is testing if a new drug called tovorafenib can be a better treatment for children with low-grade glioma compared to standard chemotherapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment400 (estimated)
AgesN/A to 25 Years
SexAll
SponsorDay One Biopharmaceuticals, Inc. (industry)
Drugs / interventionschemotherapy, radiation
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT05566795 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial evaluates the efficacy, safety, and tolerability of tovorafenib monotherapy compared to standard of care chemotherapy in pediatric participants with low-grade glioma that have a specific RAF alteration. Approximately 400 treatment-naïve participants will be randomly assigned to receive either tovorafenib or one of four standard chemotherapy regimens chosen by their investigator. The treatment cycles for tovorafenib will repeat every 28 days unless there is disease progression or unacceptable toxicity. The study aims to determine if tovorafenib provides a better treatment option than traditional chemotherapy for this patient population.

Who should consider this trial

Good fit: Ideal candidates are children under 25 years old with low-grade glioma and a known activating RAF alteration requiring first-line systemic therapy.

Not a fit: Patients with certain tumor types, such as schwannoma or diffuse intrinsic pontine glioma, or those with additional pathogenic molecular alterations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and tolerable option for children with low-grade glioma.

How similar studies have performed: Other studies have shown promise with targeted therapies in similar conditions, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participant has any of the following tumor-histological findings:

  1. Schwannoma
  2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
  3. 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 this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Low-grade Glioma, Rapidly Accelerated Fibrosarcoma Altered Glioma, Pediatric Low-grade Glioma, Rapidly accelerated fibrosarcoma, RAF alteration glioma, Glioneural tumor, Ojemda

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.