Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
Status:
Recruiting
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
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.