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news.Bayer Pharmaceuticals and Onyx Pharmaceuticals have initiated a phase III clinical trial studying Nexavar tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer.
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The multicenter study will compare Nexavar when co-administered with the chemotherapeutic agents versus the chemotherapeutic agents alone.
The study, which is expected to enroll approximately 900 patients, will assess overall survival as the primary endpoint. Secondary endpoints include progression-free survival, tumor response and safety.
“Despite recent therapeutic advances, non-small cell lung cancer remains a devastating disease,” said Dr Susan Kelley, vice president, Oncology, Bayer. “In early clinical studies, we observed preliminary activity in a small number of non-small cell lung cancer patients who received Nexavar administered in this drug combination.”
Bayer and Onyx also reported today that the FDA has completed a special protocol assessment (SPA) for the phase III non-small cell lung cancer trial. An SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.
In 2005, Nexavar received FDA approval for the treatment of patients with advanced kidney cancer.