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

Prior treatment

• Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Other

• Participant has any of the following tumor-histological findings:
  • Schwannoma
  • Subependymal giant cell astrocytoma (Tuberous Sclerosis)
  • Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
• Participant's tumor has additional pathogenic molecular alterations, (even if histologically low-grade) including but not limited to any of the following: a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
• Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2) via genetic testing or current diagnostic clinical criteria.

• Less than 25 years of age with LGG harboring a documented known activating RAF alteration, as identified through molecular assays performed at Clinical Laboratory Improvement Amendments (CLIA) or other similarly certified laboratories.
• Histopathologic diagnosis of glioma or glioneuronal tumor.
• At least one measurable T2/FLAIR lesion that can be reproducibly measured in at least 2 dimensions of at least 10 millimetres (mm), visible on 2 or more axial slices that are preferably, at most, 5 mm apart with 0-mm skip.
• Meet indication for first-line systemic therapy.