Woman and Man
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Extract
The primary objectives of this study are to assess the efficacy of single agent, oral, once daily, Tarceva (150 mg/day) at increasing the DFS following complete surgical resection with or without adjuvant chemotherapy in the following patient populations: · Overall Population: Patients who have EGFR-positive tumor tissue (by IHC and/or FISH); · Selected Subset Population: For regulatory submission in the US: Patients who have EGFR-positive tumor tissue by FISH. For regulatory submission in Rest of World (ROW): The subset population will be prospectively defined in the Statistical Analysis Plan before the first interim analysis. The reason for delaying the definition of the subset population until that time is that more information on which biomarkers are most suitable for identifying the subgroups of patients benefiting most from Tarceva therapy will become available from currently ongoing studies at that time.
Inclusion criteria
- Stage IB-IIIA Non-small Cell Lung Carcinoma with EGFR-positive tumors,Cáncer de Pulmón de células no pequeñas en Estadios IB-IIIA con tumores EGFR- positivo