Apr 18, 2014 -
SWOG study S1400, better known as the lung master protocol and now termed simply Lung-MAP, will formally launch in the coming weeks. You'll hear more about Lung-MAP as launch day approaches and will learn much about its unique rolling design, the unprecedented public-private partnerships underlying it, how it builds collaboration among the cooperative groups, and its promise for a new way of conducting meaningful clinical research. So I'll skip all of that today and tell you instead about the heroic efforts that have been and are still underway on the part of our investigators, statisticians, protocol development staff, contracts team, data managers, partners, and many others, all working to bring this complex protocol to the launch pad in what is in many ways record time.
The first draft of the protocol, which effectively incorporates five clinical trials into one master framework, went to the NCI for review in late January. That draft came back to SWOG with more than 240 separate comments and requests to be considered, discussed, and responded to. The response was edited, poked, and prodded in numerous marathon sessions before going back to the NCI for another round of review (no doubt also done in marathon fashion).
Just this week, the 300+-page protocol has been undergoing round-the-clock (and given the multiple time zones involved, I mean this literally) editing and revising to incorporate and respond to another round of reviewers' comments, so we can send it back to CTEP this weekend.
With each cycle, we move closer to activation, and we are now very near having the Lung-MAP protocol in final form, ready to submit for Central IRB review, and then to send out to the expert hands of you, our members, to work that very human magic that happens where cutting-edge research meets high-level patient care. One of Lung-MAP's primary goals is simple proof-of-concept. We've designed this approach so we can move promising targeted agents into clinical trials as soon as safely possible. The trial also ensures a rapid review at the end of the phase II portion of each sub-study, facilitating a transition of the most promising drugs seamlessly into definitive phase III testing using the same infrastructure. This ensures the next generation of potentially life-extending targeted agents can get to the FDA for rapid review and approval, so they can be used more broadly to start helping a patient with few current options.
If we can make that happen -- and we will -- then the sweat and sleep-deprivation will have been well worth it. I personally thank all involved in the study, inside and outside SWOG, for their efforts.