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news.ArQule and Daiichi Sankyo have announced the completion of patient recruitment in Phase III clinical trial of Tivantinib in advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) patients.
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The Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC (MARQUEE) trial began enrollment in January 2011 and is being conducted under a Special Protocol Assessment (SPA), which was established following agreement with the FDA.
Daiichi Sankyo R&D global head and senior executive officer, Daiichi Sankyo Pharma Development president Glenn Gormley said, "At the time of diagnosis with lung cancer, more than half of all patients have progressed to advanced stages of the disease, with a poor prognosis for long-term survival. There is a high unmet need for additional effective treatment options for patients and their families."
Tivantinib is currently in Phase III development and has not yet been approved for any indication.