The National Cancer Institute (NCI) is teaming up with Amgen and other partners as part of a new clinical trial program that aims to use genomic profiling to match squamous cell lung cancer patients to treatments based on their individual cancer profiles. The program, dubbed the Lung Master Protocol (Lung-MAP), is reportedly the first trial of its kind to study a large number of rare lung cancer subsets under one protocol.
Lung-MAP, NCI says, is a biomarker-driven, multi-drug, multi-arm Phase II/III registration trial for patients with squamous cell lung cancer that will evaluate five compounds—four targeted therapies and an anti-PD-L1 immunotherapy—and use genomic sequencing to screen around 500 to 1,000 patients each year for over 200 cancer-related genes to match said patients to the treatment arms most likely to help them. Amgen's anticancer mAb rilotumumab will be among the compounds tested.
“This latest collaboration can significantly speed our understanding of targeted approaches for this complex and underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design,” Amgen's evp, R&D Sean E. Harper, M.D., said in a statement. “It may ultimately tell us more about how best to match patients to the right treatments.”
Other Lung-MAP collaborators include SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), Genentech, Pfizer, AstraZeneca, MedImmune (AstraZeneca's global biologics R&D arm), and Foundation Medicine. NCI’s National Clinical Trials Network plans to conduct the trial at more than 200 medical centers, and SWOG will lead the trial.
The NCI adds that the trial infrastructure could test up to five to seven additional drugs over the next five years and will cost up to $160 million. NCI is contributing some funding for the program through its Cancer Therapy Evaluation Program, and additional funding will be provided by the participating companies as part of a FNIH-managed partnership that NCI says also involves the FDA, Friends of Cancer Research, and other patient advocacy organizations.