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Clinical trial tests promising immunotherapies for advanced lung cancer

Sherman Baker Jr., M.D., medical oncologist and member of the Developmental Therapeutics research program at VCU Massey Cancer Center, is spearheading a phase 3 clinical trial testing two immunotherapy drugs, MEDI4736 and tremelimumab, for the treatment of patients with advanced lung cancer. The goal of the study is to determine whether MEDI4736 combined with tremelimumab or MEDI4736 by itself is more effective than traditional chemotherapy treatment to treat advanced lung cancer.

“Cancer cells employ several defenses to prevent the immune system from recognizing and destroying them,” says Baker. “The two drugs in this study are part of a new class of immunotherapies, and they work in different ways to boost the immune system’s ability to fight cancer.”

The study lasts for 18 months, and is divided into screening, treatment and follow-up periods.

Patients enrolled in the study will have a biopsy of their tumor taken for testing. In addition, participants will also undergo blood testing for hepatitis and HIV in order to prevent potential side effects from the drugs’ interactions with the immune system.

If eligible, participants will intravenously receive either MEDI4736 with tremelimumab, MEDI4736 alone or standard chemotherapy treatment. Computer software will randomly determine which participants receive each treatment so that accurate comparisons can be made.

After finishing treatment, patients will continue to come to the clinic for monitoring, which may involve CT scans and other imaging tests.

“These drugs are fairly new and have not yet been approved by the FDA for the treatment of lung cancer, so, like any clinical study, participants will be monitored closely for side effects,” says Baker. “We are aware of potential impact to the liver, kidneys and thyroid when taking these medications, so patients with preexisting conditions affecting these organs must consult with their physician and possibly undergo additional testing before being enrolled in the study.”

The study is sponsored by AstraZeneca AB, and more than 1800 patients with advanced lung cancer are predicted to take part at 11 study sites throughout the country.

For more information about this trial, please call Faith McFadden R.N., B.S.N., O.C.N., clinical research nurse coordinator, at (804) 628-0616 or email mcfaddenfr@vcu.edu and reference clinical trial D419AC00001.

Written by: Massey Communications Office

Posted on: May 26, 2016