clinical trial · NCT07004075
FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.·phase3·not yet recruiting·n = 102
Low-grade GliomaPediatric Low-grade GliomaspLGG With BRAF AlterationLuvometinibChemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide
brief summary
An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation
started
Jun 30, 2025
primary completion
Apr 30, 2027
completion
Apr 30, 2029
last updated
Jun 4, 2025
official title
An Open-label, Randomized, Multi-center Phase III Clinical Study: Aim to Evaluate the Efficacy and Safety of FCN-159 Monotherapy Versus the Treatment by Investigator's Choice in Patients With Pediatric Low-grade Glioma Harboring KIAA1549-BRAF Fusion or BRAF V600E Mutation
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol