Today marks a major step forward in cancer clinical trials and drug development with the launch of the Lung-MAP protocol to evaluate new treatments for squamous cell lung cancer, a common cancer which has proven resistant to the standard drugs currently available. In response to this genuine unmet need, Lung-MAP has been designed to move new therapies more quickly from the laboratory to the bedside of patients afflicted with this serious disease and few options available.
Many--including present company--have written about the need to improve this process. We are in a new era of cancer drug development, spearheaded by our ever increasing knowledge of cancer genes and the targets within those genes that can be used to disrupt the cancer cell on its inexorable road to proliferation and destruction. Getting those drugs speedily through development and clinical testing has been a real challenge. And, going forward, finding the patients with the "right" genomic signature who are candidates to receive these therapies is going to be difficult. In simple terms, we need to find the patients where they live and match them to these new drugs as quickly as possible. And that hopefully will translate into more and better treatments for patients, and save lives.
The Lung-MAP program is a bold new approach that could serve as a model for clinical trials of new drugs in lung cancer and a number of other cancers if it goes well. A program put together by a collaboration of public and private groups, including the National Institutes of Health, the Food and Drug administration, clinical trial groups, drug and laboratory companies and advocacy organizations among others, Lung-MAP hopes to evaluate 5 new drugs and recruit upwards of 1000 patients to its trials within the first year.
What is unique about this effort is that patients with recurrent squamous cell lung cancer will essentially have a "one stop shop" to find out if they are eligible for one of the several different treatments being evaluated. There is a "master protocol" that has been developed by experts in the field of lung cancer, the FDA and the pharmaceutical industry participants that applies to the drugs being tested and future therapies as well. Patients will have their cancers screened for over 200 genetic markers to see if they have one that matches the drugs being investigated. If not, they will be considered for treatment with one of the new immunotherapy drugs that has promise in squamous cell lung cancer. No more shopping around for multiple trials at multiple places. It is all packaged together to make participation and evaluation as convenient as possible.
Lung-MAP could lead to a new way to test cancer therapies, make the process more efficient and less costly, and get new drugs to patients faster. But it means that patients, their families and their doctors need to make it happen. And we know from past experience that has not been easy.
Traditionally, only 3-5% of patients enter clinical trials for cancer treatment in the United States. That has proven to be a very disappointing statistic. Every time I see a presentation on a clinical trial at a national meeting, there is always a slide and a comment acknowledging the incredible contributions made by patients who participate in clinical trials to advance our knowledge about cancer treatment. It has been said often that they are our real heroes. The patients are the ones who have helped us learn what works in cancer care--and what doesn't. We can't make progress without them. But getting into clinical trials has been problematic for some. Maybe patients don't know these trials exist. Maybe they don't want to be "guinea pigs." Maybe their doctors don't talk to them about clinical trials since it may mean they have to go to a major cancer center to get their care. Whatever the reason, we could do better--and we must. This effort is a very real step forward to do just that.
Lung-MAP is going to be run out of 200 centers nationwide initially meaning there is a reasonable likelihood for most people that they will be near a center that is participating. And hopefully over time that number is going to increase. We need oncologists and other health professionals to learn about Lung-MAP, take up the charge and encourage patients to participate. As we unfortunately know, for patients who have failed initial therapy for recurrent squamous cell lung cancer there really isn't much else that works. Maybe it is time that we as a nation will understand if we are going to make progress in this brave new world of cancer treatment driven by genomic analysis we are all going to have to commit to a better way of doing research on whether new therapies offer real promise where there was little to none before.
So here's hoping today's launch of Lung-MAP marks the beginning of a new era.. Here's hoping that by this time next year the program will have met its initial goals and perhaps expand even further. But more important, here's hoping that this bold new initiative will mark a new era for the people in our lives afflicted with this terrible disease.
We offer our thanks and admiration to those who made Lung-MAP possible, and pray that it will bring real benefits to those afflicted with squamous cell lung cancer to whom we owe our commitment to do everything possible to meet their needs and expectations at a time of genuine distress in their lives.
If you want more information about Lung-MAP, follow one of the links above. You can also call the American Cancer Society at 800-227-2345 and one of our cancer information specialists will be glad to speak to you about Lung-MAP. If you are a patient or a family member of a patient with recurrent squamous cell cancer of the lung, your participation in this trial may be a treatment option that you should consider. Talk to your oncologist and or other health professional, and be your own advocate. Learn what you need to know. The American Cancer Society has provided funding to this collaboration. Most important, we are here to help you so call us if you have any questions.