NCT07004075View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2029

Conditions
Low-grade GliomaPediatric Low-grade GliomaspLGG With BRAF Alteration
Interventions
DRUG

Luvometinib

Luvometinib oral tablet

BIOLOGICAL

Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide

Investigator's choice of chemotherapy administered IV or orally

Trial Locations (1)

100070

Beijing Tiantan Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY