Carcinoma, Non-small-cell Lung
Conditions
Keywords
Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib
Brief summary
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
Interventions
DRUGTarceva (erlotinib HCl, OSI-774 )
Sponsors
Canadian Cancer Trials Group
OSI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of stage IIIB or IV non-small cell lung cancer. * Must have evidence of disease (clinical or radiological). * Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days. * If the patient has had surgery, the surgery was at least 2 weeks ago. * Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms. * If the patient received radiation therapy, treatment was at least 4 weeks ago.
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Germany, Greece, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand, United States
Outcome results
None listed