Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00275132
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.
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.
Study:
NCT00275132
Study Brief:
Protocol Section:
NCT00275132