A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
- 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.
- 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
between date of randomisation and date of death from any cause
Siow M Lee, MD, PhD, FRCP
University College London Hospitals
United Kingdom: Medicines and Healthcare Products Regulatory Agency