GIOTRIF rPMS in Korean Patients With NSCLC
Conditions
Carcinoma, Non-Small-Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: GIOTRIF 20mg Type: Drug
Name: GIOTRIF 40mg Type: Drug
Name: GIOTRIF 30mg Type: Drug
Overall Status
Recruiting
Summary
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)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: 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
Locations
Boehringer Ingelheim Investigational Site 2
Busan, Korea, Republic of
Status: Recruiting
Boehringer Ingelheim Investigational Site 4
Busan, Korea, Republic of
Status: Recruiting
Boehringer Ingelheim Investigational Site 5
Daegeon, Korea, Republic of
Status: Recruiting
Boehringer Ingelheim Investigational Site 3
Daegu, Korea, Republic of
Status: Recruiting
Boehringer Ingelheim Investigational Site 1
Jeonnam, Korea, Republic of
Status: Recruiting
Start Date
October 2014
Completion Date
January 2020
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page