Amgen announced that it will collaborate with the National Cancer Institute and other public and private sector partners on the Lung Master Protocol (Lung-MAP), a clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles.
In the U.S., lung cancer is the leading cause of cancer death and the second most common cancer.1 Approximately 25-30 percent of non-small cell lung cancers, the most common form of lung cancer, are squamous cell carcinomas. However, there are limited treatment options available for squamous cell carcinomas and development of treatments has been further complicated by the number of potential genetic mutations associated with this form of cancer. Research has demonstrated that squamous cell lung cancer has more than double the genetic mutations compared to other forms of cancer.
Lung-MAP is a biomarker-driven, multi-drug, multi-arm Phase 2/3 registration clinical trial for patients with squamous cell lung cancer. The trial will evaluate five investigational compounds intended to treat squamous cell lung cancer and use genomic sequencing to assign enrolled patients to the treatment arms most likely to provide benefit. Patients will then be randomized into one of five sub-studies where they will receive either standard of care (docetaxel or erlotinib) or biomarker-driven targeted therapy with an investigational agent. Each of these sub-studies will be independently powered for overall survival (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase 2 into Phase 3.
Approximately 500 to 1,000 patients will be screened each year for more than 200 cancer-related genes, and the screenings will inform trial arm selection. Five investigational drugs have been selected for inclusion in the initial trial, including Amgen's rilotumumab, an investigational fully human monoclonal antibody designed to inhibit cancer cell growth and migration.
"Amgen has been at the forefront of biomarker research in an effort to help the medical community understand the different mechanisms of cancer progression and ensure that patients receive treatments that will provide the greatest benefit," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This latest collaboration can significantly speed our understanding of targeted approaches for this complex and underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design. It may ultimately tell us more about how best to match patients to the right treatments."
- PHYSICAL SCIENCES
- EARTH SCIENCES
- LIFE SCIENCES
- SOCIAL SCIENCES
Subscribe to the newsletter
Stay in touch with the scientific world!
Know Science And Want To Write?
- World Did NOT End On 29th July! AWFUL "Silly Season" Story - Journalists Please Be More Responsible
- Why An Extra Planet Can't Be Hidden Behind The Sun Or Above The South Pole
- My Applied National Security Paper. Being President Isn't For Idiots.
- Why Do Consumers Participate In 'green' Programs?
- Hugh Hefner's Wife Was Not Poisoned By Breast Implants
- Mind The (Risk Perception) Gap On BPA
- SYRINA: A Trojan Horse For Endocrine Disrupting Chemicals?
- "hey Alex,yeah ok...."
- "You mean, is it edible?Yes it is. Though the digestibility of the oil has not yet been studied..."
- "Quark colors are considered in the framework of the SM weak interactions for the first time. In..."
- "Yes absolutely. Nobody has predicted any astronomical event successfully from the Bible. And it..."
- "so this vídeo armageddon News is fake???..."
- Tracking how HIV disrupts immune system informs vaccine development
- Green monkeys acquired Staphylococcus aureus from humans
- Researchers find molecular switch that triggers bacterial pathogenicity
- Scientists identify immunological profiles of people who make powerful HIV antibodies
- Breastfeeding associated with better brain development and neurocognitive outcomes