When I began as an oncologist in the late 1970s, hormone therapies were revolutionizing breast cancer treatment. But as I witnessed in my early career caring for military veterans, the outlook for lung cancer was dismal. I saw it as an opportunity to make a difference.
Today, lung cancer remains the No. 1 cancer killer of men and women. It is a disease that will affect nearly 225,000 people in the U.S. this year and kill more than 159,000, accounting for about 27 percent of all cancer deaths.
The fight against this most complex of cancers has made some progress, however. We better understand the genetic characteristics of individual tumors, and we have been able to develop and test drugs specifically targeted to some of those tumors, extending and improving the quality of our patients’ lives. At the UC Davis Comprehensive Cancer Center, for example, I have late-stage lung cancer patients who are working, exercising, traveling and spending precious time with their families because we were able to match their tumor to a drug designed for their particular molecular profile.
Unfortunately, because of an outdated, inefficient and costly process of drug development, clinical trial recruitment and drug approval, new, more effective therapies are often too few and too late. We need a new approach, one that streamlines the process and exploits the tremendous advances made in genomics and DNA sequencing technologies that can reveal the genetic variations and mutations that spur tumor growth.
This month, federal health agencies, pharmaceutical companies, advocacy groups and cancer specialists around the country embarked on a collaboration, with the launch of a multicenter, multidrug clinical trial matching lung cancer patients with promising new treatments based on each patient’s unique tumor profile.
The approach we have taken is unprecedented in the history of cancer clinical trials. Its aim is to find effective treatments faster by giving more patients access to experimental therapies, optimizing the clinical trial infrastructure and reducing recruitment hurdles for patients and their doctors.
Called the Lung Cancer Master Protocol, or Lung-MAP, the trial will simultaneously test five experimental drugs, including four molecularly targeted drugs and an immunotherapy drug for squamous cell lung cancer. Approximately 1,200 patients will be screened per year, and each will be assigned to the trial arm best matched to their tumor’s genomic profile.
The protocol is a major departure from the traditional clinical trial model. In a typical trial for a targeted therapy, patients undergo multiple single-gene diagnostic tests to determine if they are eligible for one of many different studies. This trial will use just a single test for more than 200 cancer-related genes for genomic alterations. We estimate that based on the results of the test, 60 percent of patients will be eligible for one of four investigational, targeted drugs being tested in the trial. The rest will go into a trial of a fifth drug, an immunotherapy.
We anticipate that many more patients will be able to access promising new drugs because more than 500 medical centers across the U.S. will offer the trial, and because all the clinical investigators will share information and infrastructure. Unlike typical trials of targeted drugs, often hampered by low patient accrual rates, this trial will draw a majority of eligible patients, making collection of clinical data easier and faster. That should translate into quicker approval of effective new therapies for patients who need them now.
Even if some arms of the trial don’t succeed, the information we get can fuel research into other promising therapies.
Like any new approach, the master protocol system will face its challenges. But we are prepared for them. We’ve already overcome the greatest challenge: getting often disparate interests, even competitors, to work together in an unprecedented way on a common problem. Never before have the Food and Drug Administration, SWOG (the nation’s leading cancer clinical trials cooperative group), National Cancer Institute, Foundation for the National Institutes of Health, and five pharmaceutical companies and private advocacy organizations collaborated like this to tackle any kind of cancer. If the approach is successful, the cost to develop new drugs will be just one-tenth of what a pharmaceutical company would normally spend on its own.
The long-term goal is for the protocol to be self-sustaining. As arms of the study close after meeting their research goals, we can open new arms to test new therapies. If the approach works for lung cancer, it could be a model for addressing additional cancers and other complex diseases. Lung cancer patients – and anyone facing a life-threatening illness – deserve no less.
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