A phase II/III trial using genomic profiling to match patients with investigational treatments began recruiting patients with advanced squamous cell lung cancer on June 16, 2014.
The Lung-MAP (Lung Cancer Master Protocol) trial is a public-private collaboration among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, and five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune).
"Lung-MAP represents the first of several planned large, genomically driven treatment trials that will be conducted by NCI’s newly formed National Clinical Trials Network (NCTN)," Dr. Jeffrey S. Abrams, associate director of NCI’s Cancer Therapy Evaluation Program, said in a press release announcing the trial launch. "The restructuring and consolidation of NCI’s large trial treatment program, resulting in the formation of the NCTN, is quite timely, as it now can offer an ideal platform for bringing the benefits of more precise molecular diagnostics to cancer patients in communities large and small, " he said.
Lung-MAP is expected to enroll 10,000 patients and be completed in 2022. To be eligible, patients will have progressed after receiving exactly one front-line, platinum-containing metastatic chemotherapy regimen. Between 500 and 1,000 patients will be screened per year for more than 200 cancer-related gene alterations. Based on the tumor profiles, all patients will then be assigned to one of five initial treatment arms, testing four investigational targeted treatments and an anti-PD-L1 immunotherapy.
The trial will be conducted at more than 200 medical centers. As many as five to seven additional drugs may be evaluated over the next 5 years, the press release said. Information on enrolling patients can be found on the trial website.