The “master protocol” study for squamous cell lung cancer will start on Monday, Maria Freire, president of the Foundation for NIH (FNIH), told BioCentury. The five-year protocol — a Phase II/III trial intended to support registration of new drugs — was designed by Friends of Cancer Research (FOCR) in collaboration with FDA. FNIH, a public-private biomedical research partnership, and SWOG, a cooperative cancer trial group, will manage the trial. Companies will pay for the trial to evaluate their drugs, and after seeing preliminary data will have the option to continue or independently conduct a Phase III trial(see BioCentury, Nov. 4, 2013).
About 6,000 patients will be screened using the genomic platform from Foundation Medicine Inc.(NASDAQ:FMI) and will be assigned to treatment arms based on genomic profiles. FOCR previously disclosed the initial compounds to be studied:AZD4547, a fibroblast growth factor receptor(FGFR) tyrosine kinase inhibitor from AstraZeneca plc (LSE:AZN; NYSE:AZN);MEDI4736, a humanIgG1mAb targeting programmed cell death 1 ligand 1(CD274molecule;PD-L1;B7-H1) from AZ’sMedImmune LLC; palbociclib (PD-0332991), a cyclin dependent kinase 4 (CDK4) and CDK6 inhibitor from Pfizer Inc.(NYSE:PFE); taselisib (GDC-0032), aphosphoinositide 3-kinase (PI3K)inhibitor from theGenentech Inc.unit ofRoche(SIX:ROG; OTCQX:RHHBY); and an arm combiningrilotumumab(AMG 102), a human mAb against human hepatocyte growth factor/scatter factor (HGF/SF) from Amgen Inc.(NASDAQ:AMGN), with Tarceva erlotinib. Additional agents may be added in the future.