A Phase II, Open Label Study of Gefitinib (IRESSA) in Treatment-Naïve Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer and Somatic Activating Mutations in the Epidermal Growth Factor Receptor
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with previously untreated stage
IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK
region of the epidermal growth factor receptor (EGFR) gene treated with gefitinib.
Secondary
- Determine response duration, progression-free survival, and overall survival of
patients treated with this drug.
- Determine the safety of this drug in these patients.
- Compare the ability of various somatic activating mutations in the TK region of the
EGFR gene to predict response in patients treated with this drug.
- Compare the ability of various somatic activating mutations in the TK region of the
EGFR gene to predict toxicity of this drug in these patients.
- Define a molecular profile in patients who initially respond to treatment with this
drug but subsequently progress on therapy.
- Determine the significance of germline polymorphisms of the EGFR gene, somatic
amplification of the EGFR gene, and other molecular factors for their association with
clinical outcome parameters in these patients.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate
No
Lecia V Sequist, MD, MPH
Principal Investigator
Massachusetts General Hospital
United States: Federal Government
04-291
NCT00411047
September 2005
December 2012
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |