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

This study is specifically looking for children and young people under the age of 25. To be considered, you must have a diagnosis of a low-grade brain tumour (glioma or glioneuronal tumour) that has a specific genetic change called a RAF alteration. Your tumour also needs to be easily measured by scans, and your doctor must believe that you need medication as your very first treatment.

There are also reasons why someone might not be able to join the study. For instance, certain other types of brain tumours (like schwannoma or some aggressive gliomas) are not included. If your tumour has other significant genetic changes or if you have specific genetic conditions like neurofibromatosis, you likely wouldn't be eligible.

Also, if you've already had non-surgical treatments for your tumour, such as chemotherapy, targeted drug therapy, or radiation, you would not be able to join this particular study. The study is focused on people who are receiving medication for the first time.

If you join this study, you'll be randomly assigned to one of two groups. One group will receive the new medicine, tovorafenib, and the other will receive standard chemotherapy. Treatment cycles for both groups will generally repeat every 28 days. You'll continue treatment as long as the medicine is working and you're not experiencing difficult side effects, or until the study ends. You will have regular appointments for check-ups, blood tests, and scans (like MRI) to see how the treatment is working and to monitor for any side effects. The exact number of visits and tests will be explained in detail by the study team. You will be closely monitored throughout your time in the study.