500 Boylston Street, Boston, MA 02116 617-419-4700
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This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar
pill following complete surgical removal of the tumor with or without chemotherapy after
surgery in Stage IB-IIIA NSCLC patients.
Ages:18 and older
Inclusion Criteria: - Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests - Patients may have up to 4 cycles of chemotherapy after surgery - Complete removal of the tumor by surgery - Able to start drug under the following timelines: - 6 months from the day of surgery for patients who get chemotherapy - 3 months from the day of surgery for those who do not get chemotherapy - Confirmed diagnosis of Stage IB-IIIA NSCLC - Patients must be accessible for follow-up visits Exclusion Criteria: - History of prior radiotherapy for NSCLC either before or after surgery - History of heart disease or uncontrolled heart arrhythmias within the previous year - History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug - History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years - Patients who have received chemotherapy for NSCLC before surgery - Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.
Sponsor: OSI Pharmaceuticals
Phase: Phase 3
Trial ID: NCT00373425
Not Accepting Healthy Volunteers