drugset / Trial / NCT07004075
FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration
Phase 3
Not yet recruiting
102 enrolled
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-06-30
- Primary completion
- 2027-04-30
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Subject | Luvometinib | Small molecule | 5 mg/m2 | Oral |
| Comparator | Temozolomide | Small molecule | — | Oral |
| Comparator | Vindesine | Small molecule | — | Intravenous |