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Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

NCT03711422 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-06-14

No results posted yet for this study

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

Interventions

DRUG

Afatinib

40mg daily

DRUG

Afatinib

160mg for 3 days every 3 weeks

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Daniel SW Tan, MD · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT03711422 on ClinicalTrials.gov