Clinical Development
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 vs. chemotherapy in 2nd line therapy in 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
Other Studies
A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/Erlotinib or Erlotinib Alone in Advanced Non-Small Cell Lung Cancer Patients with Performance Status 2 Selected by Serum Proteomics (SWOG S0709)
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 ± carboplatin and paclitaxel) for testing in Phase III against Standard of Care, based on minimum median PFS for > 3 months
- Secondary endpoint: Response Rate in patents with measurable disease
- Principal investigators: Primo N. Lara, MD, UC Davis Cancer Center & Paul Hesketh, MD, St. Elizabeth’s Medical Center
Biodesix is engaging in additional studies to explore the full utility of VeriStrat in other solid epithelial tumors and other EGFR inhibitors. If you would like to inquire regarding VeriStrat research and clinical development, please email veristratresearch@biodesix.com.