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

Comparing DAY101 to standard chemo for kids with low-grade glioma.

Recruiting
25 years and younger
All
Phase 3

This study compares the drug tovorafenib to usual chemotherapy for children with low-grade glioma, a type of brain tumor. Glioma is a tumor that starts in the brain or spine, and "low-grade" means it grows slowly. The study is looking at patients who need their first treatment. Tovorafenib is a drug taken in 28-day cycles unless the disease gets worse or side effects are too severe. In the other group, patients receive one of four chemotherapy options chosen by their doctor. The study will involve about 400 participants, who will be divided into two groups to receive either tovorafenib or standard chemotherapy. Eligible participants are under 25 years old, have tumors with specific genetic changes, and need systemic therapy.

  • Participation involves taking either tovorafenib or chemotherapy based on random selection.
  • Treatment continues until the disease progresses or side effects become unacceptable.
  • The study is for those who haven't had previous cancer treatments.
Study details
    Low-grade Glioma
    Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
    Pediatric Low-grade Glioma

NCT05566795

Day One Biopharmaceuticals, Inc.

11 May 2025

Step 1 Get in touch with the nearest study center
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