August 19, 2016 -
Two years after it was launched as the first precision medicine trial supported by the National Cancer Institute, Lung-MAP has changed with the times. I am pleased to report that this change is good. Lung-MAP is going strong.
Since December, after a major revision, registration has nearly doubled to 959 patients. Lung-MAP is offered at more than 700 sites coast to coast. Those of you in Chicago next month for the group meeting can get a full Lung-MAP update on Friday, Sept. 16, from 2:30-3:30 p.m. in Regency D of the Hyatt. But I wanted to give everyone a preview here.
Lung-MAP is a unique ďumbrellaĒ trial that simultaneously tests several potential treatments for squamous cell lung cancer. As you know, about 20 percent of all lung cancers are squamous cell histology, and effective treatments remain elusive. Patients on the protocol undergo genetic screening of their tumors, and can either be matched to a new, targeted treatment or be placed in a sub-study testing nivolumab, the new immunotherapy, or a nivolumab combination treatment.
Lung-MAP is special not only because of its precision drugs and innovative design. Itís special because of its partners. While SWOG coordinates Lung-MAP, every adult group in the National Clinical Trials Network is accruing patients. And the NCI, the Foundation for the National Institutes of Health, and the Friends of Cancer Research have put in thousands of hours of work on the trial, helping to ensure it is a success. Weíve also had great support from pharmaceutical partners, including AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Janssen Research & Development, Novartis, and Pfizer.
Conducting such a complex and novel trial certainly isnít easy. There have been a few bumps, especially with FDA approval last year of nivolumab Ė a major change to standard of care treatment. But the December revision made enrollment faster and easier, and made the trial more enticing.
Lung-MAP keeps evolving, and this year has added patient reported outcomes. More exciting changes are ahead. Right now, the trial offers three sub-studies of targeted treatments and one non-match immunotherapy sub-study. Later this year, we expect to open a new sub-study evaluating a PARP inhibitor.
A new Lung-MAP site coordinators committee, made up of 12 clinical research professionals from across the U.S. and Canada, gathers for the first time in Chicago. The group will advise the study chairs and the accrual enhancement committee on enrollment strategies, patient and promotional materials, changes to study procedures, data collection, and staff training materials. In addition, the accrual enhancement committee is hard at work on a promotional campaign geared to patient advocacy groups that will include a video, social media graphics, an electronic brochure, and more.
Thanks to the many people and partners working on Lung-MAP and helping it evolve over time and with changes in science and oncology. Special thanks to the thousands of investigators helping us accrue. Your commitment is deeply appreciated.