Lung-MAP Study Pioneers New Approach to Testing Cancer TreatmentsJun 16, 2014
A new kind of large research study is being planned to test 5 different experimental drugs at the same time, all for advanced squamous cell lung cancer.
Most research trials of new treatments test only 1 drug and try to figure out which patients might be helped by it. The Lung-MAP trial will take a different approach. Researchers will look at the DNA from each volunteer patient’s lung tumor to find out what changes are causing it to grow. They will then assign the patient to the arm of the study that’s testing a drug designed to target those specific genetic changes.
Lung-MAP is a collaboration among the National Cancer Institute and other public and private cancer research and advocacy organizations, and 5 pharmaceutical companies.
This new approach holds the promise of delivering more answers sooner about whether new treatments are successful, says Maria Freire, PhD, President and Executive Director of the Foundation for the National Institutes of Health, one of the sponsoring institutions. “This master protocol will allow multiple enrollees to be tested once and assigned to a treatment likely to work for them, rather than separate tests for separate trials with most patients ineligible,” she said.
Squamous cell lung cancer represents about 25% - 30% of lung cancer cases. Chemotherapy is the main treatment for advanced disease, but its effects are often limited. A goal of the Lung-MAP trial is to improve patients’ access to promising new drugs, as well as making it easier for researchers to find patients to help them test the drugs.
This type of lung cancer actually has many subtypes with different gene profiles, explains Dr. Charles Blanke, Chair of SWOG Cancer Research, another sponsoring institution. Each subtype may require a different treatment. “The Lung-MAP S1400 trial models a way to efficiently study a large number of these rare squamous cell subsets under one master protocol," Blanke says.
Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, says Lung-MAP is a “bold step forward” in improving how research is done by allowing more patients to participate in clinical studies.
“That will hopefully translate to getting exciting new medicines into the clinic more quickly than ever thought possible,” he says. Although the Society was not involved in designing the study, it is helping spread the word to patients and doctors.
Taking part in Lung-MAP
People who have advanced squamous cell lung cancer and have completed no more than 1 type of chemotherapy may be eligible to join the Lung-MAP study (also known as SWOG S1400).
If you join the study, a research team will send samples of your tumor to a laboratory to be analyzed. The samples can come from a past surgery or biopsy, or a new biopsy. The researchers are looking for changes in more than 200 cancer-related genes. If they find 1 or more of the genetic changes that are being targeted in Lung-MAP, they’ll assign you to an arm of the trial that is testing a drug designed to target the specific changes found in your tumor. If they don’t find any of the genetic changes targeted by Lung-MAP, you’ll have the option to enroll in the arm of the trial that’s testing an experimental drug not targeted to a specific genetic change.
Each arm of the trial will test whether an experimental drug is more effective in stopping the growth and spread of the cancer and extending patients’ lives than the standard treatment patients would be likely to get if they were not in a clinical trial. Half the participants in each study arm will get the experimental drug and the other half will get the standard treatment. A computer program is used to randomly make the assignments.
The trial will be conducted at more than 200 medical centers around the country. To learn more about the study or find a participating medical center, visit the Lung-MAP website or clinicaltrials.gov.