DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Public ClinicalTrials.gov record NCT05566795. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05566795
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 418 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 26, 2023
- Primary completion
- May 31, 2027
- Completion
- May 31, 2031
- Last update posted
- May 13, 2026
2023 – 2031
United States locations
- U.S. sites
- 38
- U.S. states
- 26
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital of Orange County Main Campus - Orange | Orange | California | 92868 | — |
| Packard Children's Hospital Stanford | Palo Alto | California | 94304 | — |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106-3322 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Health | Gainesville | Florida | 32610 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals Clinics | Iowa City | Iowa | 52242 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan - - C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Children's Minnesota | Minneapolis | Minnesota | 55404 | — |
| Childrens MS Cncr Ctr Bld Dsr | Jackson | Mississippi | 39216 | — |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-6878 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| New York University Langone Health | New York | New York | 10016 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Duke Cancer Institute | Durham | North Carolina | 27705 | — |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | — |
| Oregon Health Science University | Portland | Oregon | 97239 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05566795, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05566795 live on ClinicalTrials.gov.