For Immediate Release

Please Contact: Ryan Hohman, JD, Managing Director, Policy and Public Affairs, Friends of Cancer Research: 202.944.6708 – rhohman@focr.org or Frank DeSanto, Communications Manager, SWOG Cancer Research: 503.348.1710 – desanto@oshu.edu

Innovative Lung-MAP Lung Cancer Trial Open and Enrolling Patients at over 400 Sites in 39 States

Trial will Close One of Five Trial Sub-Studies: Other four sub-studies of targeted treatments for squamous cell lung cancer will continue to enroll patients, with new sub-studies in development.

 

The Lung Cancer Master Protocol (Lung-MAP) clinical trial study team announced today that, in light of Amgen’s recent announcement of the closure of its clinical trials of the drug rilotumumab in advanced gastric cancer, the Lung-MAP sub-study that is testing rilotumumab to treat squamous cell lung cancer will be immediately closed.

Those patients on the rilotumumab sub-study (sub-study S1400E) are being notified by their local physicians of the trial closure and the reasons for it.  Lung-MAP currently has nine patients that have been enrolled to this sub-study.  All are being treated with erlotinib, and roughly half were also getting rilotumumab.  Those patients will stop taking rilotumumab immediately, but will continue to be treated with erlotinib, which is a standard second-line treatment for patients with advanced squamous cell lung cancer. Lung-MAP is currently screening and enrolling patients at 400 sites in 39 states, and more are opening every week. A complete list of Lung-MAP sites can be found at: www.Lung-MAP.org/locations.

“Keeping patient safety as our first priority, and based on the science and data from other clinical trials where this therapy is being tested, the Lung-MAP study team has decided to proceed with appropriate caution and remove rilotumumab from this trial,” said Dr. Roy Herbst, Chief of Medical Oncology at Yale University.

“Part of the innovative design of Lung-MAP is that, as a master protocol, it’s designed to be modular, with sub-studies under that protocol closing as needed and new ones quickly opening as promising new targeted therapies become available for testing,” said Dr. David Gandara, Director, Thoracic Oncology Program, UC Davis.

“This sort of plug-and-play design means the huge investment of time, money, and expertise that has gone into planning and launching the trial remains productive.  The rilotumumab sub-study is being closed, but the other Lung-MAP sub-studies currently underway continue without interruption, and additional sub-studies are in development,” said Dr. Vali Papadimitrakopoulou, Professor, Department of Thoracic/Head and Neck Medical Oncology, MD Anderson.

Herbst, Gandara, and Papadimitrakopoulou are principal investigators on the study.

The Lung Cancer Master Protocol (Lung-MAP) is a multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer, a form of lung cancer with few established treatment options beyond surgery. Whereas clinical trials for targeted medicines have historically tested patients for a single biomarker and enrolled only a portion—sometimes a very small portion—of patients tested, Lung-MAP uses new comprehensive genomic profiling technology to simultaneously test patients for many biomarkers connected to several different experimental treatments. The advantages over traditional clinical trials are clear: patients only need to be tested once, they are screened for compatibility with a wider range of investigational drugs, and every patient tested is enrolled into one of Lung-MAP’s sub-studies.

Lung-MAP is the product of a unique public-private 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 leading cancer and lung cancer patient advocacy organizations (a full list is at https://lung-map.org/about/partners).

 

For more information about Lung-MAP, please visit: www.Lung-MAP.org

ClinicalTrials.gov Entry Page: https://clinicaltrials.gov/ct2/show/NCT02154490?term=1400&recr=Open&rank=4

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About the Lung-MAP Partners

SWOG Cancer Research

SWOG Cancer Research is a consortium that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. The approximately 5,000 physician-researchers in the group’s network practice at more than 650 institutions nationwide, including 28 of the National Cancer Institute (NCI)-designated cancer centers, as well as cancer centers in almost a dozen other countries.  Formerly the Southwest Oncology Group, SWOG is part of the NCI’s National Clinical Trials Network and is supported primarily through NCI research grant funding.  The group is headquartered at the Knight Cancer Institute at the Oregon Health & Science University in Portland, Oregon, (503-494-5586), has an operations office in San Antonio, Texas, and has a statistical center in Seattle, Washington. Its non-profit arm, The Hope Foundation, operates in Ann Arbor, Michigan. Learn more at swog.org (@SWOG).

The National Cancer Institute

The National Cancer Institute (NCI) leads the National Cancer Program and the NIH effort to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at http://www.cancer.gov or call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

The Foundation for the NIH

The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate key issues of scientific study and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1996, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit www.fnih.org.

Friends of Cancer Research

Friends of Cancer Research develops groundbreaking partnerships and creates a more open dialogue among both public and private sectors and tears down the barriers that stand in the way of conquering cancer. By collaborating with premier academic research centers, professional societies, and other advocacy organizations, Friends is able to accelerate innovation. For more information, please visit: http://www.focr.org or follow us on twitter @CancerResrch