Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (TOPICAL)
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.
|Lung Cancer||Drug: erlotinib hydrochloride Drug: Matched placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy|
- Overall survival [ Time Frame: between date of randomisation and date of death from any cause ]
- Progression free survival [ Time Frame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death. ]
- Adverse events/Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment ]
- Quality of life [ Time Frame: between randomisation and 8 weeks. ]QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).
- Cost-effectiveness [ Time Frame: from date of randomisation to death ]Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.
|Study Start Date:||April 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Tarceva (OSI-774, erlotinib) PO 150mg daily
Drug: erlotinib hydrochloride
Tarceva (OSI-774, erlotinib) PO 150 mg daily
Placebo Comparator: Matched placebo
Matched placebo PO daily
Drug: Matched placebo
Matched placebo PO daily
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275132
|London Lung Cancer Group|
|London, England, United Kingdom, NW1 2ND|
|Study Chair:||Siow M Lee, MD, PhD, FRCP||University College London Hospitals|