Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05566795 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

NCT05566795 · ClinicalTrials.gov record · last posted 2026-05-14

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

Name: DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) — clinical trial record (NCT05566795)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 3

SponsorDay One Biopharmaceuticals, Inc.

Started2023-02-27

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 1 change detected by DataLookout

2026-05-15

Trial status changed: Recruiting → Active, Not Recruiting

Trial Details

NCT Number	NCT05566795
Lead Sponsor	Day One Biopharmaceuticals, Inc. Collaborators: SIOPe Brain Tumor Group LOGGIC Consortium
Conditions	Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, Pediatric Low-grade Glioma
Enrollment	418 participants
Start Date	2023-02-27
Primary Completion	2027-06 (estimated)
Study Completion	2031-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-14