At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 265 enrolled
Drug / intervention
Gefitinib +3 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.
A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
In Brief
A Phase 3 clinical trial evaluating Gefitinib, Placebo, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 265 participants across 61 sites in 11 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesChina, France, Germany, Hong Kong, Hungary, Italy, Japan, Russia, South Korea, Spain, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartMar 2012
Primary CompletionMay 2014
Study CompletionNov 2019
TodayJul 2026
First PostedMar 5, 2012
Enrollment StartMar 15, 2012
Primary CompletionMay 5, 2014
Study CompletionNov 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.3 years ago
Interventions
Gefitinibdrug
Investigational Drug
Placebodrug
Matching placebo as comparator
Pemetrexeddrug
Chemotherapy (concomitant therapy)
Cisplatindrug
Chemotherapy (concomitant therapy)