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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | Genentech |
| ClinicalTrials.gov Identifier: | NCT00257608 |
Purpose
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 |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: placebo Drug: erlotinib HCl |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
Oral repeating dose
|
| Placebo Comparator: 2 |
Drug: bevacizumab
Intravenous repeating dose
Drug: placebo
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 248 Study Locations| Study Director: | Donald Strickland, M.D. | Genentech |
More Information
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00257608 History of Changes |
| Other Study ID Numbers: | AVF3671g |
| Study First Received: | November 21, 2005 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
NSCLC Lung Cancer ATLAS Avastin Tarceva |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Bevacizumab Erlotinib |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |