Novelos Therapeutics, a US biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, has reached the target enrollment of 840 patients in a pivotal Phase III trial in advanced non-small cell lung cancer for its lead product NOV-002 in combination with first-line chemotherapy.
This randomized, open-label, international study, being conducted under a Special Protocol Assessment, has enrolled 840 patients with Stage IIIb/IV NSCLC since enrollment started in November 2006. The trial is evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone. The trial, with a primary efficacy endpoint of improvement in median overall survival, is being conducted across approximately 100 clinical sites in 12 countries. The study will conclude upon reaching 725 events, which Novelos expects in mid-2009.
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