Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518011
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2007-08-16
Brief Title:
A Study of Tarceva Erlotinib and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open Label Study Comparing the Effect of First-line Therapy With Tarceva Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine compared with gemcitabine alone in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1 8 15 and every 4 weeks subsequently or with gemcitabine monotherapy The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None