At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 161 enrolled
Drug / intervention
INC280 +1 moredrug
Likely dose
Gefitinib 250 mgfrom 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 IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
In Brief
A Phase 2 clinical trial evaluating INC280 and Gefitinib for Non-small Cell Lung Cancer. Completed, enrolled 161 participants across 31 sites in 14 countries.
Detailed Summary
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesAustralia, Belgium, China, France, Germany, Israel, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedJun 2012
Primary CompletionJun 2016
Study CompletionMay 2020
TodayJul 2026
First PostedJun 4, 2012
Enrollment StartApr 5, 2012
Primary CompletionJun 10, 2016
Study CompletionMay 27, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.1 years ago
Interventions
INC280drug
During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.
Gefitinibdrug
Gefitinib 250 mg taken once daily