Status and phase
Conditions
Treatments
About
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.
STUDY OBJECTIVES
Primary: Objective response rate
Secondary: Progression free survival, Overall survival and Safety of Tarceva
Full description
Study Design: Phase II trial, open label, non-randomized and multicenter.
Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
Sex
Ages
Volunteers
Inclusion criteria
Age 18 years.
Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
Measurable disease.
Written informed consent must be obtained prior to the inclusion into the trial.
Karnofsky performance status of 80%.
Patients must have been treated with no prior chemotherapy or radioterapy.
Patients must have adequate bone marrow, liver and renal function.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
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Central trial contact
Joaquin Casal, MD
Data sourced from clinicaltrials.gov
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