The Lung Cancer Master Protocol, or Lung-MAP, will expand to include all patients diagnosed with non-small cell lung cancer.
Lung-MAP — the first large-scale precision medicine lung cancer trial backed by the NCI — is supported by a partnership with NCI’s National Clinical Trials Network, SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, pharmaceutical companies and lung cancer advocacy organizations.
The trial previously focused on treatments for advanced-stage squamous cell lung cancer. Allowing all patients with NSCLC — which represents 85% of lung cancer diagnoses in the U.S. — to enroll on the trial means thousands of new patients will be eligible.
“We have more than 200,000 new cases of NSCLC in the United States each year, and we desperately need new treatments,” principal investigator Vali A. Papadimitrakopoulou, MD, chief of thoracic medical oncology and professor of medicine at The University of Texas MD Anderson Cancer Center, said in a press release. “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.”
In addition to the expanded eligibility for enrollment, Lung-MAP will incorporate a new screening protocol that uses liquid biopsies, as well as a streamlined informed consent form that combines screening and prescreening. The trial also will mandate that hospitals, clinics and other sites that open the trial use the NCI’s Central Institutional Review Board to oversee trial changes to speed the process of entering and registering patients.
Further, Lung-MAP will open two new drug substudies — one testing a PARP inhibitor and another testing a combination of a PD-L1 and VEGF inhibitor — early this year. Another two substudies are in development and are scheduled to open in late summer.
“The changes to Lung-MAP are excellent for both patients and science,” Ellen Sigal, MD, chair and founder of Friends of Cancer Research, said in the release. “These additions to the trial mean patients will have a much easier time enrolling, so they may start fighting their cancer more quickly with investigational therapies better suited for them. Additionally, through these new procedures being introduced, researchers will be able to conduct more streamlined research and get answers to the important questions faster.”
The trial is currently offered at more than 650 U.S. medical centers and community hospitals, and it has registered more than 1,700 patients since it launched in June 2014. Nine studies — six of which have been completed — have been launched within the program.
Lung-MAP uses a single “master protocol” that is amended as drugs enter and exit the trial, preserving infrastructure and patient outreach efforts. Compared with other programs that must design each trial individually, this protocol improves the efficacy and cost-effectiveness of Lung-MAP.
“The Lung-MAP trial has already proven its value by successfully completing trials with new targeted agents in selected, molecularly defined subsets of squamous cell lung cancer. This amendment to the trial will allow patients with all types of non-small cell lung cancer to potentially benefit,” Meg Mooney, MD, MBA, acting associate director of the NCI’s Cancer Therapy Evaluation Program, said in the release. “Checkpoint inhibitors have produced a major advance in this refractory cancer, and Lung-MAP now intends to build on the success of these immunotherapy agents by adding new agents to further increase the effectiveness of this approach.”