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Name of the Trial

Pilot Study of Erlotinib in Patients with Stage IIIB or IV or Recurrent Non-Small Cell Lung Cancer (ECOG-E3503). See the protocol summary ³.

Principal Investigators

Dr. Julie Brahmer and Dr. Anne Traynor of the Eastern Cooperative Oncology Group.

Why This Trial Is Important

Lung cancer is the leading cause of cancer deaths in the United States. Several drugs developed recently to treat patients with non-small cell lung cancer (NSCLC) have targeted a receptor protein called epidermal growth factor receptor (EGFR). EGFR, which is found in abundance on some cancer cells, can promote cancer cell growth, survival, and metastases.

Erlotinib (Tarceva) is one drug that targets EGFR. Already approved by the FDA as a second-line treatment for advanced NSCLC, erlotinib has been proven in clinical studies to extend the lives of some, but not all, patients with advanced NSCLC. In this study, researchers hope to identify tumor characteristics associated with responses to erlotinib treatment. The study will also test erlotinib as a first-line treatment for advanced NSCLC.

"In past trials, researchers noticed that patients who developed a rash in response to erlotinib experienced prolonged survival," said Dr. Brahmer. "In this trial, we are also escalating the doses so that most, if not all, patients will develop a rash, and then we can see if that equates to an improvement in survival.

"With this trial, we hope to learn how to predict who will benefit from erlotinib as first-line therapy," Dr. Brahmer said.

Contact Information

This clinical trial is no longer accepting new patients. To locate other clinical trials for lung cancer, search the NCI's database of clinical trials ⁴ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.

Published Results

Kolesar J, Brahmer J, Lee J, et al.: Final results of ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7588, 406s, 2007.

Solomon BJ, Roder H, Robert R, et al.: Validation of proteomic classifier for clinical benefit from erlotinib as first line treatment for advanced non-small cell lung cancer (ECOG 3503). [Abstract] J Clin Oncol 25 (Suppl 18): A-7508, 387s, 2007.

Kolesar J, Brahmer J, Li S, et al.: ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-7162, 404s, 2006.

Glossary Terms

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

A drug used to treat certain types of non-small cell lung cancer. It is also used together with gemcitabine to treat pancreatic cancer and is being studied in the treatment of other types of cancer. Erlotinib is a type of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Also called CP-358,774, erlotinib hydrochloride, OSI-774, and Tarceva.

Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called induction therapy, primary therapy, and primary treatment.

Treatment that is given when initial treatment (first-line therapy) doesn’t work, or stops working.