Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446225
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2007-03-08
Brief Title:
Phase III Study Tarceva vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
Sponsor:
Spanish Lung Cancer Group
Organization:
Spanish Lung Cancer Group
Study Overview
Official Title:
Phase III Multicenter Open-label Randomized Trial of Tarceva vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR
Status:
COMPLETED
Status Verified Date:
2022-06
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:
EURTAC
Brief Summary:
A Phase III multicenter open-label randomized trial of Erlotinib Tarceva versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase TK domain of the EGFR
Detailed Description:
This is a multicenter phase III randomized open-label clinical trial
146 patients with a diagnosis of advanced stage IIIB and stage IV non-squamous-cell non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor EGFR will be recluted
The primary objective is to compare the progression-free survival in both treatment arms of the study conventional chemotherapy vs erlotinib in patients with non-squamous-cell non-small-cell lung cancer NSCLC in advanced stage stages IIIB and stage IV who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor EGFR
146 patients with a diagnosis of advanced stage IIIB and stage IV non-squamous-cell non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor EGFR will be recluted
The primary objective is to compare the progression-free survival in both treatment arms of the study conventional chemotherapy vs erlotinib in patients with non-squamous-cell non-small-cell lung cancer NSCLC in advanced stage stages IIIB and stage IV who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor EGFR
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003568-73 | EUDRACT_NUMBER | None | None |