At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 375 enrolled
Drug / intervention
Erlotinibdrug
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.
Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
In Brief
A Phase 3 clinical trial evaluating Erlotinib for Non-Small Cell Lung Cancer. Completed, enrolled 375 participants across 4 sites.
Detailed Summary
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesSerbia
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedAug 2012
Primary CompletionSep 2017
TodayJul 2026
First PostedAug 17, 2012
Enrollment StartJan 20, 2012
Primary CompletionSep 7, 2017
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.9 years ago
Interventions
Erlotinibdrug
Daily oral doses administered until disease progression or unacceptable toxicity or death.