The Lung Cancer Master Protocol (Lung-MAP), the first precision medicine trial in lung cancer supported by the National Cancer Institute (NCI), is undergoing a major expansion to include patients with all non–small cell lung cancers (NSCLCs).
The trial previously tested treatments for people with advanced-stage squamous cell lung cancer. Opening the trial to all types of advanced-stage NSCLCs means that thousands of new patients will be eligible to enroll.
“We have more than 200,000 new cases of NSCLC in the United States each year, and we desperately need new treatments,” said Lung-MAP principal investigator Vali Papadimitrakopoulou, MD, Chief of Thoracic Medical Oncology and Professor of Medicine at The University of Texas MD Anderson Cancer Center, in a statement. “When most people are diagnosed with NSCLC, their cancer has already grown and spread to other organs. If standard therapies don’t work for these patients—and often they don’t—they need alternatives. Lung-MAP provides those alternatives.”
More Changes to Lung-MAP Methodology
Lung-MAP will also undergo other key changes. These include:
- A new screening protocol to include the addition of liquid biopsies, as well as a streamlined informed consent form that combines screening and prescreening—a step that will make it easier to enroll patients.
- Two new drug substudies, one testing a poly ADP ribose polymerase inhibitor and another testing a programmed cell death ligand 1 and a vascular endothelial growth factor inhibitor in combination scheduled to open in early 2019. Two more substudies are scheduled to open in late summer 2019.
- A new mandate that requires hospitals, clinics, and other sites that open the trial to use the NCI’s Central Institutional Review Board to oversee trial changes, another move to speed the process of opening the trial at sites and registering patients.
More About the Trial
Lung-MAP is the first large-scale precision medicine trial in lung cancer backed by the NCI and the first major NCI cancer trial to test multiple treatments, simultaneously, under one “umbrella” design. Lung-MAP is also a public/private partnership, one that includes the National Cancer Institute and its National Clinical Trials Network (NCTN)—including SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), Foundation Medicine, pharmaceutical companies which provided their drugs for the study, and several lung cancer advocacy organizations.
Since the trial is offered at more than 650 U.S. medical centers and community hospitals under the NCTN and the NCI Community Oncology Research Program, Lung-MAP makes it easier for patients to participate and receive investigational treatments. Where typical trials require the development of individual studies for each new drug tested, Lung-MAP uses a single master protocol, which is amended as drugs enter and exit the trial, preserving infrastructure and patient outreach efforts. This makes Lung-MAP more efficient and cost-effective.
Since it launched in June 2014, Lung-MAP has registered more than 1,700 patients across the country. Trial leaders have worked with 10 pharmaceutical partners, in coordination with the FNIH, to launch nine studies, six of which are completed. The new trial is also addressing questions about the efficacy of immunotherapies and immunotherapy combinations and the validity of new biomarkers. The trial has produced critical insights into the conduct of large-scale precision medicine trials, including tissue sampling and banking, genetic screening, and patient communication.
SWOG manages Lung-MAP. The study team, led by Dr. Papadimitrakopoulou, also includes Roy Herbst, MD, PhD, of Yale Cancer Center; David Gandara, MD, and Philip Mack, PhD, both of the University of California Davis Comprehensive Cancer Center; Mary Redman, PhD, of Fred Hutchinson Cancer Research Center; and Fred Hirsch, MD, PhD, of the University of Colorado.