NCT05379803

High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

A Single Arm, Multicenter Clinical Study of High-dose Furmonertinib in First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.

Detailed description

This is a single arm, multicenter clinical study and will recruit about 40 EGFR mutated NSCLC patients with CNS metastases in China. Furmonertinib is a third generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) .The recruited patients will receive high-dose furmonertinib (160mg/day) as first-line treatment. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Furmonertinib	furmonertinib 160 mg orally QD

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2022-05-18
• Last updated: 2024-09-19

Locations

1 site across 1 country: China