Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07004075 | FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration | PHASE3 | NOT YET_RECRUITING | 102 | — | — | Jun 30, 2025 | Apr 30, 2029 | Jun 4, 2025 | 1 | China |
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
| Arm | Type | Description |
|---|---|---|
| Experimental arm: Luvometinib | EXPERIMENTAL | FCN-159, 5 mg/m\^2, once daily, continuous oral administration |
| Comparator: investigator's choice of chemotherapy | ACTIVE_COMPARATOR | Chemotherapeutic Agent COG-V/C, intravenous solution for injection Carboplatin + Vindesine, intravenous solution for injection Carboplatin, intravenous solution for injection Temozolomide, orally Day 1 to Day 5 of each 28 days as a cycle |
| Name | Type | Description |
|---|---|---|
| Luvometinib | DRUG | Luvometinib oral tablet |
| Chemotherapeutic Agent COG-V/C Carboplatin + Vindesine, Carboplatin, Temozolomide | BIOLOGICAL | Investigator's choice of chemotherapy administered IV or orally |
Inclusion Criteria: 1. Pediatric patients aged between ≥ 2 years and \< 18 years; regardless of male or female. 2. 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). 3. KIAA1549-BRAF fusion or...