GIOTRIF rPMS in Korean Patients With NSCLC



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - 110
Updated:11/23/2016
Start Date:October 2014
End Date:January 2020
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Trial Summary
Trial Overview
Inclusion Criteria

A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF®(Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutation(s)

To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean
patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)


Inclusion criteria:

1. Patients who have been started on GIOTRIF® in accordance with the approved label in
Korea

2. Age = 19 years at enrolment

3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to afatinib or any of its excipients

2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption

3. Patients for whom GIOTRIF® is contraindicated according to the local label
We found this trial at
2
sites
Boehringer Ingelheim Investigational Site
One or more investigational sites, Texas
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One or more investigational sites, TX
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Boehringer Ingelheim Investigational Site
One or more investigational sites,
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mi
from
One or more investigational sites,
Click here to add this to my saved trials