NCT07004075

FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Low-grade Glioma
• Pediatric Low-grade Gliomas
• pLGG With BRAF Alteration

Interventions

Type	Name	Description
DRUG	Luvometinib	Luvometinib oral tablet
BIOLOGICAL	Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide	Investigator's choice of chemotherapy administered IV or orally

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-04-30
• Completion: 2029-04-30
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China