Onyx/Bayer initiate Ph III Nexavar trial

2 June 2009

Germany's Bayer and US drugmaker Onyx Pharmaceuticals have begun enrolling patients in an international Phase III trial to evaluate  Nexavar (sorafenib) tablets in patients with non-squamous non-small cell  lung cancer who have failed two or three previous treatments.

The MISSION trial is an international multicenter study that will enroll  approximately 850 patients with advanced relapsed or refractory  non-squamous cell NSCLC who have failed two or three previous  treatments. Patients will be randomized to receive either Nexavar as a  single agent or placebo.

In both arms, best supportive care will be provided. The primary  endpoint of this trial is overall survival, and secondary endpoints  include progression-free survival and overall response rate. The safety  and tolerability of the two treatment groups will also be compared.

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