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A Phase II Trial of Erlotinib in Patients with Resected, Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor Mutations
[Protocol 08-152]
- Full 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)
- Purpose :
The goal of this study is to evaluate the effectiveness of erlotinib (Tarceva®) in patients with early-stage non-small cell lung cancer (NSCLC) that has been surgically removed and contains certain mutations in the epidermal growth factor receptor (EGFR). Investigators want to see if erlotinib can prevent or delay a recurrence of the cancer.
Erlotinib is already approved for the treatment of NSCLC that persists despite previous chemotherapy. It works by blocking EGFR, which may control tumor growth and tumor cell survival. EGFR is found on the surface of many types of cancer cells, including NSCLC. Previous research has shown that erlotinib is most effective for people who have specific mutations in the gene that makes EGFR.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage IA-IIIA NSCLC that has been surgically removed in the last 6 months and contains EGFR mutations.
- Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation.
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Christopher Azzoli at 212-639-2131.
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