Purpose of this Study
This study has three parts. First is the screening phase, where doctors check if a person can join. Next is the treatment phase, where the person gets the study medicine and has an End of Treatment visit. Last is the long-term follow-up, where doctors watch the person’s health for a long time. This includes a safety check 30 days after treatment. A person may be in the study for up to 5 years.
There are two groups in the study. People will be placed into a group by chance. One group will get the study medicine, and the other group will get chemotherapy chosen by the doctor. The study medicine is called Tovorafenib. It is used to treat certain brain tumors in children and young adults, especially a type called pediatric low-grade gliomas that have changes in the RAF or BRAF gene.
Who Can Participate?
Eligibility
The patient is younger than 25 years old and has a brain tumor called a low‑grade glioma. The tumor has a change in the RAF gene, found by special lab tests.
The tumor is confirmed by looking at tissue under a microscope. It must be a glioma or glioneuronal tumor, Grade 1 or 2, based on the 2021 WHO rules for brain tumors.
The patient must have at least one tumor spot that can be measured on an MRI scan. The spot must be at least 10 mm in size and show up clearly in two directions on at least two scan slices. The scans must be done within 42 days before treatment starts.
The patient needs medicine as the first treatment because:
The tumor cannot be removed by surgery, and
The doctor believes the patient's health could get worse without treatment.
Age Range
0-24
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to see how well a new medicine called tovorafenib works compared to regular chemotherapy. It will check if the medicine is safe and easy to handle for children, teens, and young adults who have a type of brain tumor called pediatric low‑grade glioma (PLGG)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full 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.
Principal Investigator
Daniel
Landi
Protocol Number
PRO00111813
NCT ID
NCT05566795
Phase
III
Enrollment Status
Open to Enrollment