Abstract

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:

ALK- Masterprotocol

Small Cell Lung Cancer Masterprotocol

The Masterprotocol concept and the individual protocols will be discussed.