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 (click here for a full list).
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 (202) 444-4000.
About Georgetown Lombardi Comprehensive Cancer Center
Georgetown Lombardi Comprehensive Cancer Center, part of Georgetown
University Medical Center and MedStar Georgetown University Hospital,
seeks to improve the diagnosis, treatment, and prevention of cancer
through innovative basic and clinical research, patient care, community
education and outreach, and the training of cancer specialists of the
future. Georgetown Lombardi is one of only 41 comprehensive cancer
centers in the nation, as designated by the National Cancer Institute,
and the only one in the Washington, DC, area. For more information, go
to http://lombardi.georgetown.edu.