At a glance
ClinicalIndex Comparison RecordN/ACompleted· 228 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in 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.
Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
In Brief
An observational study for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 228 participants across 29 sites in 13 countries.
Detailed Summary
This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesAustria, Canada, France, Germany, Italy, Japan, Mexico, Poland, Singapore, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartNov 2016
Primary CompletionSep 2017
TodayJul 2026
First PostedApr 26, 2016
Enrollment StartNov 24, 2016
Primary CompletionSep 30, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago