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)
- Erlotinib is a pill taken daily and participants may continue to receive erlotinib for
up to two years, as long as the cancer does not return and they do not experience any
unacceptable side effects.
- While participants are receiving erlotinib, they will be asked to return to the clinic
for study visits to monitor the status of their disease and their general health. For
the first 5 months of erlotinib, they will return to the clinic monthly. After that
they will return to the clinic every three months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the 2-year disease-free survival of patients with resected, early stage NSCLC who have activating mutations in the EGFR gene, after treatment with adjuvant erlotinib.
Lecia V. Sequist, MD, MPH
Massachusetts General Hospital
United States: Institutional Review Board
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Stanford University||Stanford, California 94305|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hosptial||Boston, Massachusetts 02114|
|North Shore Medical Center||Salem, Massachusetts 01970|
|Taussig Cancer Center||Cleveland, Ohio 44195|