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LOGGIC/FIREFLY-2: DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients with Low-Grade Glioma Requiring First-Line Systemic Therapy
EU CTIS ID: 2024-510742-13-00
What this study is testing
To compare the ORR assessed per RAPNO criteria by Independent Review Committee (IRC) of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Less than 25 years of age with LGG with known activating RAF alteration
- Histopathologic diagnosis of glioma or glioneuronal tumor
- At least one measurable lesion
- Meet indication for first-line systemic therapy
You likely can't join if
- Patient has any of the following tumor-histological findings: a. Schwannoma b. Subependymal giant cell astrocytoma (Tuberous Sclerosis) c. Diffuse intrinsic pontine glioma, even if histologically diagnosed as WHO Grade I-II
- Patient's tumor has additional pathogenic molecular alterations
- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF1/NF-2)
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- New Zealand
- Singapore
- Canada
- Jordan
- Korea, Republic of
- Australia
- Switzerland
- United Kingdom
- Israel
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; New Zealand; Singapore; Canada; Jordan; Korea, Republic of and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.