Phase 3 Trial for Novel NSCLC Therapy Announced
(ChemotherapyAdvisor) – Pharmaceutical company OncoGenex (Bothell, WA) announced in a July 10 press release its clinical development plans for custirsen in the treatment of non-small cell lung cancer (NSCLC). The phase 3 clinical trial, which will be initiated in late-2012, will evaluate the potential survival benefit of custirsen in combination with docetaxel as second-line treatment in patients with NSCLC who have progressed after initial, or first-line, platinum-based chemotherapy has failed.
The company plans to enroll approximately 1,100 patients with advanced or metastatic NSCLC in this phase 3, international, randomized, open label study. Investigators will randomize patients to receive custirsen plus docetaxel or docetaxel alone. End points include overall survival and biomarker relationships.
Custirsen acts by a novel mechanism of action – blocking production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types and in response to anticancer treatments. In previously published phase 2 studies that evaluated custirsen in combination with a gemcitabine/platinum-based regimen in first-line NSCLC, patients experienced a median overall survival of 14.1 months, and decreased serum clusterin levels in 95% of patients evaluated, with lower serum clusterin levels correlating with survival outcomes.