If I want to join this trial, how do I find a participating center?
The study is opening at hundreds of sites across the United States. In order to find a center near you visit the Find a Location page.
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 squamous 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.
Squamous cell lung cancer accounts for about 25 to 30 percent of non-small cell lung cancer. Squamous cells are thin, flat cells that line the airways of the lungs. While squamous cell lung cancer starts in a single group of cells, it is not a single disease. There are many different changes to a person’s cancer genes that can cause squamous cells to grow out of control and become cancerous. Recently, researchers have developed new drugs that might “target” these genetic changes better and with fewer side effects.
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.
What if a patient does not have a genetic change?
For some patients, their tumor will not match any of the genetic changes that are being tested in the trial. These patients may be able to join the “non-match” sub-study, or group, in Lung-MAP.
Patients in this sub-study will receive drugs that may help their immune system fight the cancer cells. Patients in the non-match sub-study will be randomly assigned to be on one of two groups. Both offer a drug, nivolumab, which is approved for safety and effectiveness by the U.S. Food and Drug Administration for patients with advanced squamous cell lung cancer. One group of patients will be treated with nivolumab alone; the other will receive nivolumab plus another drug, ipilimumab.
Why is this study being done?
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 squamous cell lung cancer from growing. For the non-match sub-study, researchers want to compare the effects – good and bad – of using nivolumab alone and with another immune therapy drug.
Lung-MAP is focused on squamous cell lung cancer because it is common and hard to treat. There are few effective treatments for squamous patients, particularly those who don’t respond to chemotherapy.
Am I a candidate for the Lung-MAP trial?
Only patients and their doctors can decide if Lung-MAP participation is the right choice. Eligible patients have been diagnosed with advanced squamous 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, also known as S1400.
What will happen if I join this study?
A sample of each patient’s lung cancer tissue 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.
How will you get the tumor material to test?
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.
Will I learn about the results of my tumor screening?
Yes. Results of genetic testing will be reported to study doctors, who will discuss these results with their patients.
If I want to join this trial, how do I find a participating study site?
Lung-MAP is open at more than 700 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.
How is Lung-MAP different from other clinical trials?
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.
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.
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.