Name of the Trial
Phase II Study of Sorafenib in Patients with Recurrent or Progressive Stage IV Non-Small-Cell Lung Cancer (NCI-05-C-0049). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0049.

Principal Investigator
Dr. Martin Gutierrez, NCI Center for Cancer Research

Why Is This Trial Important?
Lung cancer is the leading cause of cancer-related death in the United States, and it has often spread (metastasized) by the time it is diagnosed. The likely outcome, or prognosis, for patients with metastatic lung cancer is death. Consequently, new and more effective treatments for metastatic lung cancer are needed.

In this clinical trial, researchers are testing a new drug called sorafenib to see if it can cause tumors to shrink or disappear in patients with metastatic non-small-cell lung cancer (NSCLC) that has recurred or progressed after previous treatment with chemotherapy. Sorafenib inhibits a protein called Raf kinase, which helps promote cell proliferation. Blocking Raf kinase activity may halt the spread of cancer cells.

Sorafenib also inhibits two other proteins named vascular endothelial growth factor receptors 2 and 3 (VEGFR2 and VEGFR3), which help tumors form new blood vessels (a process called angiogenesis). By blocking VEGFR2 and VEGFR3 activity, sorafenib may help cut off the blood supply to tumors and cause them to die.

"Sorafenib is a molecularly targeted oral medication with both antiproliferative and antiangiogenic properties," said Dr. Gutierrez. "It has shown some promising results against NSCLC in an earlier phase I study, and it appears to be well-tolerated. Most of the toxicity that we have seen has been mild and easy to control."

Who Can Join This Trial?
Researchers seek to enroll up to 40 patients aged 18 or over with recurrent or progressive stage IV NSCLC. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-05-C-0049.

Where Is This Trial Taking Place?
This study is taking place at the NIH Clinical Center in Bethesda, Md.

Contact Information
For more information, call the NCI Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The call is toll free and confidential.