๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-12

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) (NCT05566795)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Day One Biopharmaceuticals, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Children's of Alabama โ€” Birmingham, Alabama

Age range: Not specified to 25 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (138 Sites)

Showing the first 25 of 138 sites.

  • Children's of Alabama โ€” Birmingham, Alabama
  • Phoenix Children's Hospital โ€” Phoenix, Arizona
  • Children's Hospital Los Angeles โ€” Los Angeles, California
  • Children's Hospital of Orange County Main Campus - Orange โ€” Orange, California
  • Packard Children's Hospital Stanford โ€” Palo Alto, California
  • UCSF Benioff Children's Hospital โ€” San Francisco, California
  • Children's Hospital Colorado โ€” Aurora, Colorado
  • Connecticut Children's Medical Center โ€” Hartford, Connecticut
  • Children's National Medical Center โ€” Washington D.C., District of Columbia
  • University of Florida Health โ€” Gainesville, Florida
  • Nicklaus Children's Hospital โ€” Miami, Florida
  • Arnold Palmer Hospital for Children โ€” Orlando, Florida
  • Johns Hopkins All Children's Hospital โ€” St. Petersburg, Florida
  • Children's Healthcare of Atlanta โ€” Atlanta, Georgia
  • Ann & Robert H. Lurie Children's Hospital of Chicago โ€” Chicago, Illinois
  • University of Chicago โ€” Chicago, Illinois
  • Riley Hospital for Children at Indiana University Health โ€” Indianapolis, Indiana
  • University of Iowa Hospitals Clinics โ€” Iowa City, Iowa
  • Norton Children's Hospital โ€” Louisville, Kentucky
  • Maine Children's Cancer Program โ€” Scarborough, Maine
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • University of Michigan - - C.S. Mott Children's Hospital โ€” Ann Arbor, Michigan
  • Children's Minnesota โ€” Minneapolis, Minnesota
  • Childrens MS Cncr Ctr Bld Dsr โ€” Jackson, Mississippi
  • St. Louis Children's Hospital โ€” St Louis, Missouri

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Low-grade Glioma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—