Clinical development trials
VeriStrat Prospective Trial: PROSE
Randomized proteomic stratified Phase III study of second-line erlotinib versus chemotherapy in patients with inoperable non-small cell lung cancer (NSCLC)
Objective: To evaluate the efficacy of treatment stratification using the VeriStrat test on the effect of erlotinib versus chemotherapy in second-line therapy patients with advanced stage NSCLC.
- Initiated March 2008
- Patients with inoperable NSCLC
- Primary endpoint: Overall survival
- Secondary endpoint: Progression-free survival, overall response rate
- Italian multi-institutional study
- Principal investigator: Dr. Vanesa Gregorc, Scientific Institute, University Hospital San Raffaele, Milan Italy
SWOG S0709
A Phase II selection design of pharmacodynamic separation of carboplatin, paclitaxel, erlotinib or erlotinib alone in advanced NSCLC patients with performance status two selected by serum proteomics
Objective: To evaluate the efficacy of a pharmacodynamic separation treatment regimen of first-line NSCLC patients in a VeriStrat Good patient population.
- Initiated January 2008
- Primary endpoint: Select a regimen (erlotinib plus/minus carboplatin and paclitaxel) for testing in Phase III against standard of care, based on minimum median PFS for less than three months
- Secondary endpoint: Response rate in patients with measurable disease
- Principal invesigators: Dr. Primo N. Lara, University of California Davis Cancer Center and Dr. Paul Hesketh, St. Elizabeth’s Medical Center, Brighton, MA
ACORN eLung
A multi-center randomized Phase IIb study of cetuximab in combination with platinum-based chemotherapy as first-line treatment of patients with recurrent or advanced NSCLC.
Objective: To study maintenance therapy with cetuximab following several different regimens of platinum based chemotherapy.
- Primary endpoint: Overall survival with three different regimens of chemotherapy and cetuximab
- Secondary endpoint: Safety and one-year survival with three different regimens of chemotherapy and cetuximab; overall survival by histology
- Principal investigator: Dr. Lee Schwartzberg, The West Clinic, Memphis TN
VIEW
VeriStrat observational study of patients with NSCLC
Objective: To observe EGFR-I treatment patterns following VeriStrat analysis and to report outcomes for all study subjects.
- Initiated March 2010
- Primary endpoint: Correlation of VeriStrat results (VeriStrat Good versus VeriStrat Poor) with outcomes of progression-free survival and overall survival
Biodesix is engaging in additional studies to explore the full utility of VeriStrat in other solid epithelial tumors and other EGFR inhibitors. If you have any questions concerning VeriStrat research and clinical development, please e-mail veristratresearch@biodesix.com.
