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
Pediatric patients aged between ≥ 2 years and < 18 years; regardless of male or female.
Histologically and/or cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).
KIAA1549-BRAF fusion or BRAF V600E mutation-positive.
Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.
Patients who have received chemotherapy drugs or traditional Chinese medicines or herbals with definitive anti-tumor treatment within 4 weeks preceding the first dose of investigational drug;
Patients who have received growth factors that promote platelet or leukocyte count or function within 14 days preceding the first dose of investigational drug;
Patients who received radiotherapy, surgery or immunotherapy within 4 weeks preceding the first dose of investigational drug;
Patients who have participated in other interventional clinical trials within 4 weeks before receiving the first dose of investigational drug;