Name of the Trial
Phase III Randomized Study of Induction Platinum-Based Chemotherapy and Radiotherapy with or without AE-941 (Neovastat) in Patients with Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer (MDA-ID-99303). See the protocol summary at http://cancer.gov/clinicaltrials/MDA-ID-99303.

Principal Investigator
Dr. Charles Lu of the University of Texas M.D. Anderson Cancer Center

Why Is This Trial Important?
Patients who have advanced non-small cell lung cancer (NSCLC) that cannot be removed surgically (unresectable) are often treated with platinum-based chemotherapy agents and radiation therapy in an attempt to prolong their survival.

Like other solid tumors, NSCLC requires a constant supply of blood to grow. Drugs that block the formation of new blood vessels to tumors are called angiogenesis inhibitors. Such drugs may help cancer patients survive longer. In this trial, researchers are studying the ability of AE-941 (Neovastat), a liquid extract of shark cartilage that has angiogenesis inhibitor activity, to improve the survival of patients with unresectable NSCLC when given in combination with traditional chemotherapy and radiation therapy.

"What is different about this study is that we are using a standardized extract from cartilage instead of a drug devised from a single molecule," said Dr. Lu. "Thus, Neovastat may offer a combination of molecules that work together to inhibit angiogenesis."

"Data from animal studies support the hypothesis that this extract has antiangiogenic activity and that it may inhibit certain enzymes involved in cancer cell metastasis, such as matrix metalloproteinases 2, 9, and 12," Dr. Lu added.

Who Can Join This Trial?
Researchers seek to enroll 756 patients aged 18 and over who have been diagnosed with inoperable stage IIIA or IIIB NSCLC. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/MDA-ID-99303.

Where Is This Trial Taking Place?
Study sites in the United States, Canada, and Puerto Rico are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/MDA-ID-99303.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/MDA-ID-99303 or call the NCI's Cancer Infor-mation Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.