NCT05566795
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Active, Not Recruiting
PHASE3Up to 25InterventionalTreatmentDay One Biopharmaceuticals, Inc.
~418 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:TovorafenibChemotherapeutic Agent
At a glance
Recruiting sites
0 of 138 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy
Measured over Up to 60 months
Conditions
Where it's being run
138 sites across 78 statesSpain7
Italy6
England6
Australia5
France5
Germany5
California4
Florida4
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Participant has any of the following tumor-histological findings:
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.
What this trial measures
- Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapyUp to 60 months
ORR assessed per Response Assessment in Pediatric Neuro Oncology (RAPNO) criteria by Independent Review Committee (IRC), and defined as the proportion of participants with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).