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

NCT07004075 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-06-04

No results posted yet for this study

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

Conditions

  • Low-grade Glioma
  • Pediatric Low-grade Gliomas
  • pLGG 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

Sponsors & Collaborators

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004075 on ClinicalTrials.gov