Lung Cancer Clinical Trial
Official title:
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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