Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00275132
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-12
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:
TOPICAL
Brief Summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.
Secondary
* Compare progression-free survival and response rate.
* Compare toxicity.
* Compare the quality of life.
* Compare cost-effectiveness.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral erlotinib once daily for up to 24 months.
* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.
Primary
* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.
Secondary
* Compare progression-free survival and response rate.
* Compare toxicity.
* Compare the quality of life.
* Compare cost-effectiveness.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral erlotinib once daily for up to 24 months.
* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LLCG-TOPICAL | None | None | View | |
| EU-20313 | None | None | View | |
| ISRCTN | REGISTRY | 77383050 | View | |
| Cancer Research UK (CTAAC) | OTHER_GRANT | C1438/A4147 | View | |
| Roche AG Pharma | OTHER_GRANT | MO17591 | View | |
| UCL Trial Sponsor reference | OTHER | UCL/05/173 | View | |
| EudraCT number | OTHER | 2004-000729-31 | View |