At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,329 enrolled
Drug / intervention
Gefitinib +2 moredrug
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.
Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
In Brief
A Phase 3 clinical trial evaluating Gefitinib, Carboplatin, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 1,329 participants across 56 sites in 9 countries.
Detailed Summary
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesChina, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMay 2006
Primary CompletionApr 2008
Study CompletionJun 2010
TodayJul 2026
First PostedMay 8, 2006
Enrollment StartMar 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.2 years ago
Interventions
Gefitinibdrug
oral tablet
Carboplatindrug
IV
Paclitaxeldrug
IV