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;
Parallel
Luvometinib
DrugLuvometinib oral tablet
Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide
Biological/VaccineInvestigator's choice of chemotherapy administered IV or orally
Compare the progression free survival (PFS) of FCN-159 versus chemotherapy by IRC
PFS assessed per RANO-LGG criteria by IRC, and defined as the time from randomization to the first recorded progressive disease or death from any cause, whichever is first
PFS of FCN-159 versus chemotherapy by INV
PFS assessed per RANO-LGG criteria by inverstigator
Objective response rate (ORR) of FCN-159 versus chemotherapy
ORR assessed per RANO-LGG criteria,and defined as the proportion of patients with confirmed complete response (CR), partial response (PR) or minor response (MR)
Clinical benefit rate (CBR) of FCN-159 versus chemotherapy
CBR is defined as the proportion of patients with confirmed CR, PR, MR and SD lasting ≥24 weeks as assessed based on the RANO-LGG criteria
Duration of overall response (DOR) of FCN-159 versus chemotherapy
DOR is defined as the time from the date of the first CR, PR or MR to the first recorded tumor progression or death (death due to any cause), whichever occurs earlier
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