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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Genentech |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00567359 |
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR) |
Estimated Enrollment: | 36 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lecia Sequist, MD, MPH | 617-726-7812 | lvsequist@partners.org |
Contact: Patricia Ostler, RN | 617-724-7829 | postler@partners.org |
United States, Massachusetts | |
Massachusetts General Hosptial | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Lecia V. Sequist, MD, MPH | |
Dana-Farber Cancer Institute | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Pasi Janne, MD |
Principal Investigator: | Lecia V. Sequist, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Lecia Sequist, MD, MPH ) |
Study ID Numbers: | 07-259 |
Study First Received: | November 30, 2007 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00567359 |
Health Authority: | United States: Institutional Review Board |
NSCLC erlotinib epidermal growth factor receptor EGFR |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases 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 |