First-Line Erlotinib Therapy and the Subsequent Development of Mechanisms of Secondary Resistance in Patients With Non-Small Cell Lung Cancer and Known Sensitizing EGFR Mutations
- Participants will take erlotinib orally once a day. Each treatment cycle lasts 28
days.
- While on the study, participants will be required to be seen in the clinic on Day 1 of
each treatment cycle. During these visit, the following tests and procedures will be
done: physical exam and blood tests. They will also return for blood work during Cyle
1 Day 8.
- At the end of every two cycles an assessment of the participant's tumor will be done by
CT and/or MRI (this is part of regular cancer care) as well as the following: Urine
test and blood tests.
- At the end of study treatment the following procedures will be done: blood tests,
assessment of the tumor by CT and/or MRI and a new biopsy of the tumor or removal of
fluid containing tumor cells.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To prospectively assess the frequency of different genetic mechanisms of secondary resistance in patients' tumors during treatment with erlotinib.
2 years
No
David Jackman, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
09-210
NCT00997334
December 2009
December 2014
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |