Lung-MAP is a precision medicine umbrella trial for patients with advanced non-small cell lung cancer (NSCLC), using genomic screening to match patients to investigational new treatments at more than 900 sites across the U.S.
As it moves into its second decade, the trial is undergoing another major update (Lung-MAP 3.0) and greatly broadening the list of approved next-generation sequencing (NGS) genomic tests that can be used to assign patients to a targeted Lung-MAP sub-study.
NGS testing has become a standard part of the treatment process for patients with NSCLC. This expansion of Lung-MAP means most patients who enroll to the trial can now be matched to a sub-study based on the results of earlier genomic testing, without submitting new tumor tissue or blood samples, although no-cost on-study testing remains an option for patients who need it.
The trial’s updated screening process can use results from most commercial and academic NGS platforms to identify biomarkers for matching a patient to a targeted treatment sub-study. The list of approved NGS platforms has grown to more than 40 and continues to expand.
This third generation of Lung-MAP simplifies the screening process, making trials of new treatments available to even more patients at a wider range of sites, including smaller community-based clinical sites, the type of site at which most patients are treated. By reducing barriers to screening, Lung-MAP is now even better positioned to enroll a patient population that truly reflects the demographics of those diagnosed with advanced NSCLC in the U.S.
“Lung MAP 3.0 exemplifies the ability of the trial protocol platform to remain dynamic and evolve with the shifting standards for lung cancer diagnosis and treatment to meet the needs of a broader group of patients,” said the trial’s principal investigator, Karen Reckamp, MD, of Cedars-Sinai Medical Center.
Lung-MAP opened in 2014 as an umbrella trial enrolling patients with advanced squamous-cell NSCLC. At the start of 2019, the trial’s second-generation revision broadened enrollment to include patients with non-squamous cell NSCLC as well. Through its first decade, almost all genomic screening for assigning patients to Lung-MAP sub-studies was done using the Foundation Medicine genomic testing platform. Although previous test results can now be used for Lung-MAP 3.0 screening, on-study genomic testing using the Foundation Medicine platform remains available at no cost to the patient.
“Patients can still be screened on-study, at no cost, as in the past, but for patients who already have results from previous genomic testing, there’s no need for repeat testing,” said Saiama Waqar, MD, MSCI, of Washington University School of Medicine, the trial’s co-principal investigator. “The revised Lung-MAP is more pragmatic – patients and treatment sites can now use the NGS tests they already use.”
The Lung-MAP trial is funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), through grants CA180888, CA180819, CA180820, CA180821, and CA180868 and in part by participating pharmaceutical collaborators through the Foundation for the National Institutes of Health, in partnership with Friends of Cancer Research.
Lung-MAP ADVOCACY WEBINAR
Learn more about the Lung-MAP trial at a public webinar
Wednesday, May 14th, 2025, 1 – 2 pm ET.
Advocating, Accelerating, and Amplifying Lung Cancer Discovery will feature Lung-MAP experts presenting on recent trial updates and opportunities for patient engagement, followed by a panel of lung cancer advocates discussing these topics.
Learn more and register for the webinar.
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About Lung-MAP
Lung-MAP is a unique, collaborative cancer clinical trial that uses genetic screening to match patients to investigational new treatments for non-small cell lung cancers. It is built on a groundbreaking public-private partnership that includes the NCI and the NCI-funded National Clinical Trials Network (NCTN) including SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), Foundation Medicine, pharmaceutical companies that provide their drugs for studies, and several lung cancer advocacy organizations. Lung-MAP is supported by NCI, led and sponsored by SWOG.
With the trial offered at almost 900 U.S. medical centers and community hospitals under the NCTN and the NCI Community Oncology Research Program (NCORP), Lung-MAP makes it easier for patients to receive investigational treatments to fight their non-small cell lung cancer. Lung-MAP is more flexible, efficient, and cost-effective than traditional clinical trial models, using a single “master protocol” that is amended as drugs enter and exit the trial, which preserves infrastructure and patient outreach efforts, allowing researchers to quickly answer the critical question: Does this new drug or drug combination work?
Since its launch, Lung-MAP has screened more than 5,000 patients. Trial leaders have worked with 15 pharmaceutical partners, in coordination with the FNIH, to launch 19 studies, 16 of which are completed. The trial is addressing questions about the efficacy of immunotherapies and immunotherapy combinations and the validity of new biomarkers. The trial has also produced critical insights into the conduct of large-scale precision medicine trials, including issues related to tissue sampling and banking, genetic screening, patient communication, and trial access for members of underrepresented groups.
About the Foundation for the National Institutes of Health
The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.
About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed lifesaving treatments to patients. For more information, please visit http://www.focr.org.
About SWOG Cancer Research Network
SWOG is part of the National Cancer Institute's National Clinical Trials Network and the NCI Community Oncology Research Program (NCORP). SWOG has more than 20,000 members in 46 states and eight other countries who design and conduct clinical trials to improve the lives of people with cancer. SWOG trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 3 million years of human life. Learn more at swog.org, and follow SWOG on Twitter/X at @SWOG and on BlueSky at @swog.org.
Method of Research
Randomized controlled/clinical trial
Subject of Research
People