New Clinical Trial Uses Genomics to Pair Lung Cancer Patients with Drugs

Georgetown Lombardi Comprehensive Cancer Center at MedStar Georgetown University Hospital has launched a new study that uses tumor genomic profiling to match lung cancer patients with investigational drugs designed to target the specific gene alterations driving their particular cancers.

January 9, 2015

WASHINGTON, D.C.  (January 9, 2015) — Georgetown Lombardi Comprehensive Cancer Center at MedStar Georgetown University Hospital has launched a new study that uses tumor genomic profiling to match lung cancer patients with investigational drugs designed to target the specific gene alterations driving their particular cancers.

The study, called Lung-MAP, is for people with advanced squamous cell lung cancer. Patients will be assigned to one of five groups based on their genomic testing results, and each group will receive a drug that will best match the patients’ genomic profile.

A total of five investigational drugs are being tested — four targeted therapies and an immunotherapy (anti-PD-L1). The study design allows for testing as many as five to seven additional drugs over the next five years.

“In most clinical trials, we only study one drug at a time,” explains Giuseppe Giaccone, MD, PhD, associate director for clinical research at Georgetown Lombardi. “That process can be extremely time-consuming and expensive. In this study, we’re expediting the process by testing five drugs at the same time. In addition, we obtain knowledge from the genomic profiling that tells us which drug is most likely to benefit the patient.”

Giaccone says that through this trial and others like it, “we can make advances in the treatment of cancer with fast signals of activity of novel agents that will be further examined in larger trials if results are found to be promising in this study.”

None of the study drugs in Lung-MAP are approved by the U.S. Food and Drug Administration (FDA). The primary purpose of the study is to see if an investigational drug is better than, or equal to, standard therapy.

Lung-MAP, a phase II/III study, is part of a nationwide effort involving more than 200 medical centers. Lung-MAP is expected to screen up to 1,250 patients each year for more than 200 cancer-related genomic alterations. Genomic screening takes about two weeks and may require a biopsy if a lung tumor sample is not readily available.

Lung-MAP is a unique public-private collaboration among the National Cancer Institute (NCI), SWOG, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca and MedImmune), Foundation Medicine and leading cancer and lung cancer patient advocacy organizations (a full list is available a thttp://www.lung-map.org/about/partners).

The trial is partly funded by the NCI. Significant additional funding will be provided by the participating companies as part of a partnership managed by FNIH that also involves the U.S. Food and Drug Administration, Friends of Cancer Research and other patient advocacy organizations.

Giaccone reports having no personal financial interests related to the study.

For more information about the study and other lung cancer treatments, please call the Lombardi Cancer Line at (202) 444-4000.

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