What is the Lung-MAP trial?
Lung-MAP is a large clinical trial, or research study, testing several new treatments for patients who have advanced stage non-small cell lung cancer. In advanced stage patients, the cancer has usually spread to other organs in their body. The Lung-MAP trial is for advanced stage patients whose cancer has continued to grow, even after being treated with standard therapy.
With Lung-MAP, researchers test DNA from each patient’s tumor to see if the patient has a genetic change that may be causing the cancer to grow. If a change is detected in a patient’s tumor, and if they meet other requirements, they may be eligible to get the drug that targets the specific genetic changes in their cancer cells. They will not get a placebo.
Genomic Profile Screening
Patients are screened using a comprehensive genomic profiling platform that looks at over 200 cancer-related genes for genomic alterations.
Based on the results of this screening, patients are assigned to whichever one of the sub-studies testing different investigational treatments best suits their genomic profile. If a patient's genetic profile does not match one of the targeted treatment sub-studies, they will be assigned to a non-match substudy.
This innovative approach improves a patient’s likelihood of receiving a drug targeted at the genetic profile of their particular tumor while allowing for new therapies in development to be added as the trial progresses.
For some patients, their tumor will not match any of the genetic changes that are being tested in the trial and their tumors have continued to grow or have recurred on drugs to help their immune system target their cancer. These patients may be able to join a “non-match” sub-study, or group, in Lung-MAP.
Patients in these sub-studies may receive combinations of drugs that may better help their immune system fight the cancer cells or the standard of care.
The purpose of the Lung-MAP study is to learn if the drugs that target the genetic changes in the cancer cells will slow or stop the non-small cell lung cancer from growing. For the non-match sub-studies, researchers want to compare the effects – good and bad – of using combinations of immunotherapy drugs.
Only patients and their doctors can decide if Lung-MAP participation is the right choice. Eligible patients have been diagnosed with non-small cell lung cancer, and have received at least one dose of chemotherapy. Lung-MAP patients must be at least 18 years old. Patients should ask their doctors about Lung-MAP.
A sample of each patient’s lung cancer tissue and a blood draw will be sent to a lab for genetic testing. Based on those screening results, and if patients meet other requirements, they can participate in a Lung-MAP research sub-study.
For most patients, the research team can use tumor tissue from a past biopsy or surgery. In some cases, though, doctors may need to perform another biopsy.
Yes. Results of genetic testing will be reported to study doctors, who will discuss these results with their patients.
Lung-MAP is open at sites across the United States. To find a participating site nearby, visit the Lung-MAP page on the ClinicalTrials.gov website. A list of these institutions is also available on the Find a Location page.
Lung-MAP has a few unique features.
First, it’s not a single clinical trial. It’s several sub-studies tackling a single disease and testing many treatments for it. These trials are sometimes called “umbrella” or “master protocol” trials. “Lung-MAP” is short for “lung cancer master protocol.”
Lung-MAP is the first large-scale precision medicine trial launched with support from the National Cancer Institute. With precision medicine, doctors use information about the genes, proteins, and other features of a person’s cancer to diagnose and treat the disease with precise treatments that target their cancer. The hope is that these targeted treatments will prove to be more effective than current treatments and have fewer side effects.
Lung-MAP is also special because it brings together many partners. SWOG manages the trial in collaboration with the National Cancer Institute, Friends of Cancer Research, and the Foundation for the National Institutes of Health. Other partners include pharmaceutical companies and the genomic analysis company Foundation Medicine.
The wide availability of the trial – with hundreds of sites across the country – gives many patients access to the latest treatments in their community.