NCT03711422

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

A Dose Finding Study of Continuous and Intermittent High-dose (HDI) Afatinib (EGFR TKI) on CNS Metastases and Leptomeningeal Disease (LMD) in Patients With Advanced Refractory EGFR Mutation Positive Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Brain metastases occurs in up to 50% of patients with EGFR mutant NSCLC. Leptomeningeal disease is a subset of patients with brain metastases for which there remains an unmet need. This trial aims to evaluate the role of two dosing schedules of afatinib in management of leptomeningeal disease in EGFR mutant NSCLC, specifically to determine Central Nervous System (CNS) penetration of afatinib, as well as clinical activity. Patients will start on daily dosing initially followed by pulsed intermittent dosing should we observe no clinical activity. A secondary objective is to identify the resistance spectrum in leptomeningeal disease. It is anticipated that optimal dosing schedule of afatinib e.g. pulsed dosing may improve CNS disease control.

Conditions

• Non-small Cell Lung Cancer
• Leptomeningeal Disease
• Central Nervous System Metastases

Interventions

Type	Name	Description
DRUG	Afatinib	40mg daily
DRUG	Afatinib	160mg for 3 days every 3 weeks

Timeline

• Start date: 2018-11-16
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2018-10-18
• Last updated: 2022-06-14

Locations

1 site across 1 country: Singapore