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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00257608 |
This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: placebo Drug: erlotinib HCl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer |
Estimated Enrollment: | 1150 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
Oral repeating dose
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2: Placebo Comparator |
Drug: bevacizumab
Intravenous repeating dose
Drug: placebo
Oral repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Donald Strickland, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | AVF3671g |
Study First Received: | November 21, 2005 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00257608 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NSCLC Lung Cancer ATLAS Avastin Tarceva |
Thoracic Neoplasms Erlotinib Bevacizumab Angiogenesis Inhibitors Protein Kinase Inhibitors Recurrence Carcinoma |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |