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

Home » Studies » 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

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

PI: Dr. Nirav Thacker

Study contact: [email protected]

Study contact full name: Isabelle Laforest

Research Area: Cancer

Who to contact regarding participating: Isabelle Laforest

Lay Summary: This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 study to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus SoC chemotherapy in patients with pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy. The primary objective is to compare the objective response rate (ORR) assessed per Response Assessment in Neuro-Oncology for low-grade gliomas (RANO-LGG) criteria by Independent Review Committee (IRC) of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma harboring an activating rapidly accelerated fibrosarcoma gene (RAF) alteration requiring first-line systemic therapy.