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Clinical Trial Active — Not Recruiting Phase III NCT05566795

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

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) — Active Not Recruiting • Phase III • Oncology • NCT05566795.

📅 14 May 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05566795
Start
2023-02-27
Completion
2027-06
ClinicaliQ Trial Snapshot
  • DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) — Active Not Recruiting • Phase III • Oncology • NCT05566795.
  • Tovorafenib compared to standard chemotherapy for treating children with low-grade brain tumours with RAF mutations.

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What This Trial Is Studying

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. Conditions: Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma, Pediatric Low-grade Glioma Interventions: Tovorafenib, Chemotherapeutic Agent Lead Sponsor: Day One Biopharmaceuticals, Inc. Planned Enrollment: 418 participants

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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