A national lung cancer trial launched earlier this summer with the help of a UC Davis oncologist has the potential to dramatically affect the way cancer drugs will be developed in the future.
The trial, called Lung-MAP, puts a cancer-fighting approach into action that uses genomic profiling. This involves testing a patient’s tumors for “bio markers,” or genetic identifiers, that can help physicians determine which genetically targeted drugs will work for them.
The current course of treatment for lung cancer presents patients a range of therapies, some toxic, that are not targeted for that individual’s cancer. Elizabeth Lacasia, a stage 4 lung cancer patient and active support group participant at the Bonnie J. Addario Lung Cancer Foundation in the Bay Area, called it “throwing spaghetti on the wall to see if something sticks.”
When Lacasia was diagnosed in 2006, her oncologist did not consider genomic profiling a reliable option because of its newness. After six tough and not-so-successful rounds of chemotherapy, Lacasia eventually moved to the care of Dr. David Gandara, director of the UC Davis Thoracic Oncology Program and a lead researcher on the new Lung-MAP trial. He used genomic profiling to find a combination of drugs that stabilized Lacasia’s cancer and prevented new growth for more than four years.
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What Gandara did for Lacasia is now possible on a large scale through Lung-MAP, which anticipates testing 1,200 patients nationwide each year for up to 200 genetic idenifiers.
“It just has to go this direction,” Lacasia said. “It makes complete sense. Cancer has a certain mutation, and they have a drug for it, why not give that patient that drug? Now they’re stepping back and saying lung cancer is a unique personal disease, so we should treat it on a unique personalized basis.”
The clinical trial, which launched nationally June 15, matches the patient’s genomic profile with one of five newly developed cancer-fighting drugs. If a treatment proves successful through testing, the Food and Drug Administration will register that drug and its bio marker, Gandara said. Researchers behind the trial believe the ability to screen more patients for more drugs at once will lead to more efficient approval of genetically targeted cancer therapies.
About 25 percent to 30 percent of all patients with non-small cell lung cancer, the more common of the two major types of lung cancer, will be eligible for the trial. Lung cancer is the leading cancer killer of both men and women, according to the American Lung Association.
Four of the five drugs being tested in this trial are targeted at specific genetic markers. Patients with the right profile for any one of those four drugs will be placed accordingly in a subgroup of the trial, while those who meet criteria for the study but lack the appropriate bio marker will be placed in a fifth “non-match” subgroup, said Gandara. Patients in the fifth group will receive an experimental anti PD-L1 treatment, which aids the immune system in recognizing and fighting cancer and is not reliant on genetic markers.
The launch is a collaboration between the National Cancer Institute, the Southwest Oncology Group, Friends of Cancer Research, the Foundation for the National Institutes of Health and five pharmaceutical companies. As part of the newly formed National Clinical Trials Network, or NCTN, the study will have access to more than 400 trial sites nationwide, 200 of which have already launched. The rest will join in the coming months.
“The magnitude of this will be incredible compared to anything anyone’s done in the past,” Gandara said. “Throughout Northern California, whether you’re in Chico or Fresno, patients are going to have sites where they can activate the trial. This is such a new way of doing business.”
Under the Lung-MAP protocol, enrollees who would otherwise bounce from one screening to another undergo just one diagnostic test, which simultaneously assesses eligibility for multiple drug treatments, Gandara said. Testing a patient once for compatibility with multiple drugs is also cost-effective for pharmacists, who will have access to a larger sample of cancer patients and the quality assurance protocol of the NCTN.
There are no placebos in Lung-MAP. Patients in each treatment subgroup are randomly assigned to either the targeted drug treatment program or the best standard of care available. If it becomes evident early on that the targeted treatment in any given group is performing significantly better or significantly worse than the standard of care, that sub-trial will be terminated and the protocol will be used to test a new drug.
The FDA, the NCI and the pharmaceutical industry have been in talks about this trial for more than two years. Gandara has been interested in genomic profiling for about a decade.
“It’s always been thought to be too futuristic, like Star Wars,” he said. “But now with the data on the profiling coming out everyone is realizing this is feasible.”
The UC Davis Comprehensive Cancer Center opened its trial site shortly after the national launch, making it one of the first sites to open, along with Yale University. The center intends to enroll about 10 patients in the trial every year, Gandara said. About 20 have been screened so far.
Sites at the Gene Upshaw Memorial Tahoe Forest Cancer Center in Truckee and the Rideout Cancer Center in Marysville also have been activated, along with the UC San Diego Moores Cancer Center.
If successful, the protocol may be used to perform genomic profiling tests for other cancers and in other countries in the future, Gandara said.
Ellen Sigal, founder and chair of Friends of Cancer Research in Washington D.C., said the collaboration of many groups was necessary to move the FDA toward what she sees as a more efficient, more patient-centric method of cancer drug testing.
“What all patients want is the best treatment possible,” she said. “This is a national trial with enormous ramifications for science and technology. ... We are really proud to be part of it.”