Master protocols in lung cancer
1University of Colorado Cancer Center, Colorado, USA
In order to speed up the identification of new active drugs and the approval process, the US National Cancer Institute, FDA, representatives from academic institutions and the industry met in February 2012 to discuss "How to integrate biomarkers into clinical trial designs". The conclusions from this meeting was to develop "Masterprotocols in Lung Cancer". Through unique public-private partnerships, several Masterprotocols were developed:
LungMAP; a protocol for patients with advanced squamous lung cancer, 2. Line (SWOG 1400)
ALCHEMIST study: an adjuvant study for early stage adenocarcinomas.
NCI-MATCH-trial: a biomarker driven clinical study across organs.
Several other Masterprotocols are under development:
Small Cell Lung Cancer Masterprotocol
The Masterprotocol concept and the individual protocols will be discussed.