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Sponsors and Collaborators: |
OSI Pharmaceuticals National Cancer Institute of Canada |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00036647 |
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).
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Tarceva (erlotinib HCl, OSI-774 ) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Placebo Controlled Study of OSI-744 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study Chair: | Frances Shepherd, M.D. |
Study ID Numbers: | OSI-774-BR.21 |
Study First Received: | May 13, 2002 |
Last Updated: | December 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00036647 |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Tarceva EGFR erlotinib |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |