At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 6,586 enrolled
Drug / intervention
Erlotinibdrug
Likely dose
Erlotinib 150 milligramsfrom 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 Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
In Brief
A Phase 4 clinical trial evaluating Erlotinib for Non-Small Cell Lung Cancer. Completed, enrolled 6,586 participants across 543 sites in 51 countries.
Detailed Summary
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesAlbania, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czechia, Ecuador, Egypt, Estonia, Finland, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Uruguay, Venezuela
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
Primary CompletionApr 2009
First PostedJul 2009
TodayJul 2026
First PostedJul 31, 2009
Enrollment StartNov 1, 2004
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.9 years ago
Interventions
Erlotinibdrug
Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.