At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,272 enrolled
Drug / intervention
GIOTRIF 20mg +2 moredrug
Likely dose
GIOTRIF 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
In Brief
An observational study evaluating GIOTRIF 20mg, GIOTRIF 40mg, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 1,272 participants across 1 site.
Detailed 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)
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionDec 2019
TodayJul 2026
First PostedNov 7, 2014
Enrollment StartOct 31, 2014
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.7 years ago
Interventions
GIOTRIF 20mgdrug
NSCLC with GIOTRIF 20mg
GIOTRIF 40mgdrug
NSCLC with GIOTRIF 40mg
GIOTRIF 30mgdrug
NSCLC with GIOTRIF 30mg