The trial is a product of years of collaboration with government, leadership from the US Food and Drug Administration (FDA), National Cancer Institute (NCI), and National Institutes of Health (NIH), Foundation for the National Institutes of Health (FNIH), research institutions, patient advocacy groups, and industry, and it is our hope that it will provide a model for more efficient, cooperative trials in the future.
Lung-MAP was first proposed at the 2012 Conference on Clinical Cancer Research hosted by Friends and the Engelberg Center for Health Care Reform at the Brookings Institution. Friends, in conjunction with its government (FDA, NCI, NIH) and industry partners, then developed a clinical trial design in a series of workshops, forums, and working groups. The final design was announced at the 2013 Conference on Clinical Cancer Research, along with the first five drugs to be tested.
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THE POWER OF COLLABORATION
Lung-MAP (SWOG S1400) is a multi-drug, multi-sub-study, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to sub-studies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.
Instead of having to undergo multiple diagnostic tests to determine eligibility for many different studies, enrollees are tested just once according to a “master protocol” and assigned to one of multiple trial sub-studies, each testing a different drug from a different developer. 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 needed before investigational drugs can be tested.
Patients are screened using a comprehensive genomic profiling platform that reviewed more than 200 cancer-related genes for genomic alterations. Based on the results of this screening, patients are assigned to whichever one of up to five sub-studies testing different investigational regimens best suits their genomic profile. This innovative approach improves a patient’s likelihood of receiving a drug that will work for them while allowing for new therapies in development to be added as the trial progresses.
Lung-MAP is an unprecedented, public-private collaboration between: the National Cancer Institute (NCI), NCI’s National Clinical Trials Network, SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health, several pharmaceutical companies (Amgen, Bristol-Myers Squibb, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), Foundation Medicine and several lung cancer advocacy organizations.