The Lung Cancer Master Protocol (Lung-MAP) trial uses genomic profiling to match patients with experimental treatments. It is hoped that the design will reduce recruitment and infrastructure problems for researchers.
If your medication is a gene-targeted biologic for cancer, a ‘ground-breaking collaborative trial’ of investigational products in people with squamous cell lung cancer has raised hope for one method likely to facilitate patient recruitment.
A public-private collaboration between multiple US-based, cancer-focused organisations and a group of pharmaceutical companies is screening patients with advanced squamous cell lung cancer for the gene variants linked to development of the tumour, and matching them to investigational drugs designed to treat those defects.
In view of this case, researchers developing biologics to treat cancers driven by genetic defects may want to seek out companies working on gene-targeting treatments for the same tumour and discuss the options. It is always difficult and time-consuming to enrol patients with rare and specific diagnoses. This way, patients with specified gene defects would be collected automatically through the screening stage of the trial, and the infrastructure load would be shared between the collaborating organisations.
The public side of Lung-MAP’s collaboration was composed of the National Cancer Institute, SWOG’s (formerly Southwest Oncology Group) Cancer Research, the Foundation for the National Institutes of Health, Friends of Cancer Research and Foundation Medicine Today. The private section included pharmaceutical companies Amgen, Astrazeneca, Astrazeneca’s global biologics R&D arm, Genentech, MedImmune and Pfizer.
Press release: The Wall Street Journal/Market Watch: http://www.marketwatch.com/story/groundbreaking-collaborative-clinical-trial-launched-2014-06-16