Gibbs Cancer Center & Research Institute One of First Sites in the World
Groundbreaking Clinical Trial to Conduct Lung-MAP Testing
SPARTANBURG, SC, July 1, 2014 – Spartanburg Regional Healthcare System (SRHS) announces that Gibbs Cancer Center & Research Institute (GCCRI) has been selected as one of the first 10 test sites in the world for a breakthrough clinical cancer drug trial.
A unique public-private collaboration among the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health, five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca's global biologics R&D arm, MedImmune), and Foundation Medicine announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial.
"This diverse, collaborative approach, with support from leading lung cancer advocacy organizations, helps to ensure that the needs of patients, clinicians, developers, and regulators are all considered in the design and operation of the trial," said Ellen Sigal, Ph.D., Chair & Founder of Friends of Cancer Research.
One benefit of the trial is enrollment efficiency, since it offers a single test that looks at more than 200 cancer-related genes, rather than requiring a separate screening process for each trial. A single “master protocol” can be modified as different drugs enter and exit the trial. If a drug meets predetermined efficacy and safety criteria, the drug and its accompanying diagnostic biomarker will be eligible for FDA approval. This new process will bring safe and effective drugs to patients sooner than they might otherwise be available.
That means shared information and infrastructure, better access for patients to promising drugs, better access for researchers to relevant enrollees based on their genomic profiles, and less time and money are needed before new drugs can be tested. This is one of two significant NCI initiatives with GCCRI this year. A five-state, multi-year research consortium grant was recently awarded to GCCRI. For more information on this trial, please visit www.lung-map.org.