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 at http://cancer.gov/clinicaltrials/ECOG-E3503.

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

Why is This Trial Important?
Lung cancer is the leading cause of cancer death 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.

Who Can Join This Trial?
Researchers seek to enroll 129 patients aged 18 and over that have been diagnosed with stage IIIB or IV or recurrent NSCLC and have not received prior treatment for their cancer. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/ECOG-E3503.

Where Is This Trial Taking Place?
Study sites in the United States are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/ECOG-E3503.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E3503 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.