DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requirin… (NCT05566795) | Clinical Trial Compass
Active — Not RecruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
United States, Australia, Austria418 participantsStarted 2023-02-27
Plain-language 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.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a targeted drug called tovorafenib to standard chemotherapy as the first treatment my child receives — given that it's a Phase 3 trial, what does that mean in terms of how much safety and effectiveness data already exists for tovorafenib in kids with low-grade glioma?
2The trial specifically targets RAF-altered gliomas — has my child's tumor been tested to confirm whether it has a RAF alteration, and if not, should we pursue that genetic testing before deciding on any treatment path?
3Since the trial is no longer enrolling new participants, what options exist for my child to potentially access tovorafenib outside of this study, such as through a compassionate use or expanded access program?
4The trial is measuring how many children's tumors respond to treatment — based on what's been observed so far in this or related studies, how does tovorafenib's response rate compare to the standard chemotherapy my child would otherwise receive?
5Given that this is a first-line therapy trial, would starting with standard chemotherapy now close the door on any future options, or could my child potentially access tovorafenib or similar RAF-targeted treatments later if the first treatment stops working?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy