New landmark lung cancer study will use genomics to match patients with 5 possible experimental drugs
Medimmune, the biologics unit of AstraZeneca has teamed up with several leading pharmaceutical and diagnostics companies to launch a multi drug clinical study into advanced squamous cell lung cancer.
Other than Medimmune, the other parties involved in this partnership are Amgen, Genentech, Pfizer, Foundation Medicine, National Cancer Institute and Cancer Research.
The study has also been named the Lung Cancer Master Protocol, the study will use genomic profiling to match patients with advanced squamous cell lung cancer to one of several different drugs which are intended to target the genomic alterations that promote the growth of their cancer. This new approach to clinical testing is expected to enhance access to promising therapies for patients and also help tackle the enrolment and infrastructure challenges that researchers have when dealing with traditional clinical studies.
In the early stages of the study, they will investigate five experimental therapies, including four targeted drugs and an anti-PD-L1 immunotherapy. It has been expected that between 500 and 1000 patients will be screened annually for more than 200 cancer related genes for genomic alterations. The finding of the test will be used to help assign each participant to one of the five experimental therapies depending on what matches the genomic profile of their tumour.
The end goal of this trial is to eventually create a model of clinical testing that is more effective in meeting the needs of patients as well as drug makers. While a standard clinical study for a targeted treatment tests each potential patient for a single bio marker, and also recruits only for a fraction of patients tested. Lung-MAP will however test at the same time patients for a number of bio markers, including selected base substitutions and small gene infusions and amplifications to evaluate compatibility with several different experimental drugs.
This trial is the first part of several large planned geonomically driven treatment studies that will be carried out by the National Clinical Trials Network. Lung-MAP will be done at more the 200 medical centres, with the study capable of testing up to 5-7 additional; therapies over the next five years, which will eventually cost $160 million.
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