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

NCT05566795 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2026-05-14

No results posted yet for this study

Summary

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

DRUG

Tovorafenib

Oral Tablet Powder for Oral Suspension

DRUG

Chemotherapeutic Agent

Intravenous solution for injection

Sponsors & Collaborators

  • SIOPe Brain Tumor Group LOGGIC Consortium

    collaborator UNKNOWN

  • Day One Biopharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2027-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Egypt
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Jordan
  • Netherlands
  • New Zealand
  • Norway
  • Qatar
  • Singapore
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566795 on ClinicalTrials.gov