At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,060 enrolled
Drug / intervention
Gefitinibdrug
Likely dose
Gefitinib 250mgfrom 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.
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 4 clinical trial evaluating Gefitinib for Caucasian Patients With EGFR Mutation Positive Advanced NSCLC. Completed, enrolled 1,060 participants across 61 sites in 13 countries.
Detailed Summary
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, France, Greece, Hungary, Italy, Norway, Poland, Portugal, Romania, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionAug 2012
Study CompletionJun 2016
TodayJul 2026
First PostedSep 17, 2010
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2012
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago
Interventions
Gefitinibdrug
250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met