Lung-MAP: Master Protocol for Lung Cancer

Doctor showing a male patient information on a tablet computer. — Credit: iStock

The Trial

Lung-MAP, or the Lung Cancer Master Protocol, is a precision medicine clinical trial for people with advanced non-small cell lung cancer that has continued to grow after treatment. Non-small cell lung cancer makes up about 85% of lung cancer diagnoses. There are few treatment options for people with these cancers once it has spread beyond the lungs.

This trial is an umbrella trial. Umbrella trials allow many drugs to be tested at one time and allow for each drug to be tested in the patients who are most likely to benefit. Lung-MAP is testing several different treatments that target genetic changes found in non-small cell lung cancer. When first joining the trial, people’s tumors are screened for the presence of certain markers. These markers can include genetic changes found through genomic sequencing and other tests. Patients are then assigned to a treatment arm if their tumors have specific changes that are targeted by one of the treatments being studied in the trial. In umbrella trials, new treatment groups can be added over time as drugs become available. Other treatment groups can close after enough patients have enrolled and the data are collected.

When Lung-MAP was launched in 2014, it focused on one type of non-small cell lung cancer, known as squamous cell lung cancer. But now, the trial includes patients with all types of advanced non-small cell lung cancer.

How Patients Can Enroll in Lung-MAP

Lung-MAP is open at more than 700 sites across the United States. Find a Location shows the complete list of sites. If you are interested in joining the trial, start by speaking with your doctor or healthcare team. Eligibility criteria and other details are available in the study’s protocol summary.

Each year during the course of the study, researchers will screen between 500 and 1,000 patients with advanced non-small cell lung cancer for changes in over 200 cancer-related genes. The results of these screening tests will be used to assign patients to the treatment group that is matched to their tumor’s genetic change.

Option for People without a Match

For people whose tumors do not have genetic changes matching any of the treatments being tested, they may be able to join one of the “non-match” trials that are part of Lung-Map. Patients in these trials may receive immunotherapy drug combinations if their cancer got worse during earlier treatment with immunotherapy.

Goals of Lung-MAP

The purpose of Lung-MAP is to learn if drugs that target the genetic changes in the cancer cells will slow or stop non-small cell lung cancer from growing.

For the non-match group, researchers want to assess the effects of immunotherapy drug combinations.

Trial Collaborators

The trial is being conducted by NCI’s National Clinical Trials Network, led by the SWOG Cancer Research Network, and partly funded by NCI through its Cancer Therapy Evaluation Program. Other organizations taking part in this unique public-private collaboration include Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine.

More Information about Lung-MAP is available in the protocol summary.