SAN CARLOS, Calif. -- (BUSINESS WIRE) -- The Bonnie J. Addario Lung Cancer Foundation (ALCF) has signed on as a collaborating organization with the Lung Cancer Master Protocol (Lung-MAP) clinical trial, which will use genomic profiling to match patients to one of several different investigational treatments that are designed to target the genomic alterations found to be driving the growth of their cancer. This innovative approach to clinical testing should both improve access to promising drugs for patients and ease the significant recruitment and infrastructure burdens on researchers involved in traditional clinical trials.
“The collaborative effort put in place for the LUNG Master Protocol is a game changing process. It will revolutionize the way clinical trials are conducted, leading the way to more rapid drug development and approval for patients,” said Bonnie J. Addario, lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation. “For the first time a trial will begin with the focus on the patient and personalize their therapy to their tumor mutations rather than the reverse.”
Lung-MAP is a collaboration among the National Cancer Institute (NCI), part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), 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), Foundation Medicine and lung cancer advocacy partners, including the Bonnie J. Addario Lung Cancer Foundation, American Cancer Society, Free to Breathe, Lung Cancer Alliance, LUNGevity and Uniting Against Lung Cancer.
Lung-MAP will make it easier for patients and researchers to find one another. It will also be more flexible than traditional clinical trial models. Where typical clinical trials require the development of new protocols for each new drug tested, Lung-MAP uses a single “master protocol,” which can be amended as needed as drugs enter and exit the trial, preserving infrastructure and patient outreach efforts.
“This unprecedented public-private partnership will drive us closer to the precision medicine era where each patient gets personalized therapy for their disease, instead of blanket therapy that might not be the right treatment of choice for them, boosting survival and saving more lives,” Addario said.
Lung-MAP is a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinoma represents about a quarter of all lung cancer diagnoses, but there are currently few treatment options beyond surgery for the disease. The trial will initially test five experimental drugs—four targeted therapies and an anti-PD-L1 immunotherapy. It is anticipated that between 500 and 1,000 patients will be screened per year for over 200 cancer-related genes for genomic alterations. The results of this test will be used to assign each patient to the trial arm that is best matched to their tumor’s genomic profile.
Lung-MAP aims to establish a model of clinical testing that more efficiently meets the needs of both patients and drug developers. Whereas a typical clinical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion—sometimes a very small portion—of patients tested, Lung-MAP will simultaneously test patients for several biomarkers in order to assess compatibility with several different experimental treatments and will enroll all patients tested into one of its five trial arms.
The trial will be conducted at over 200 medical centers by NCI’s Cooperative Groups, led by SWOG, and partly funded by NCI through its Cancer Therapy Evaluation Program. Significant additional funding will be provided by the participating companies as part of a partnership managed by FNIH that also involves the Food and Drug Administration (FDA), Friends, and other patient advocacy organizations. The trial infrastructure is capable of testing as many as 5-7 additional drugs over the next 5 years, and will cost up to $160 million.
For lung cancer patients, the Lung-MAP clinical trial provides an unprecedented opportunity to access a wide range of therapies tailored specifically to their particular type of lung cancer, even when they’re still at a very early stage of clinical development (and might not be otherwise available), and being a part of our progress towards using the C word for Cure, instead of C for Control for lung cancer, sooner.
For more information on this unique clinical trial for lung cancer patients, please visit www.Lung-MAP.org.
About the Bonnie J. Addario Lung Cancer Foundation
The Bonnie J. Addario Lung Cancer Foundation is one of the largest philanthropies (patient-founded, patient-focused, and patient-driven) devoted exclusively to eradicating Lung Cancer through research, education, early detection, genetic testing, drug discovery and patient-focused outcomes. The Foundation’s commitment to lung cancer patients is to collaborate and partner with the leaders in oncology, technology, science, medicine and philanthropy to make Lung Cancer a chronically managed disease by 2023. The Foundation works with a diverse group of physicians, organizations, industry partners, individuals, survivors, and their families to identify solutions and make timely and meaningful change. ALCF was established on March 1, 2006 as a 501c(3) non-profit organization and has raised more than $10 million for lung cancer research. To learn more, please visit www.lungcancerfoundation.org.