Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.
Checked against the public recordLast updated Dec 17, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Pasi A. Janne, MD, PhD
- Interventions being studied
- Drug: Erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Female * Diagnosis of adenocarcinoma of the lung * Patient has had at least one core biopsy of her tumor * Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor * Stage four (IV) or three (III) B non-small cell lung cancer * Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago. * Three or more weeks since last radiation therapy * Three or more weeks since last major surgery * Must at least be able to walk and capable of taking care of herself although unable to carry out work activities * Life expectancy of 8 weeks or more * Blood tests that show kidneys, liver and bone marrow to be working adequately * Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study Exclusion Criteria: * Prior exposure to Tarceva (OSI-774, erlotinib) * Uncontrolled central nervous system problems * Prior chemotherapy regimen * Difficulty swallowing * A disease or disorder that interferes with ability to digest and absorb food * Incomplete healing of previous oncologic or other major surgery * Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure * Pregnant or breast feeding * A medical condition that could make it unsafe for patient to participate in this study
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 17, 2019. Always confirm current availability with the study team.