NOVELOS AND FDA AGREE TO LUNG CANCER TRIAL DESIGN

A A

After undergoing a special protocol assessment with the FDA, Novelos Therapeutics is set to begin a pivotal Phase III trial evaluating its lead product NOV-002 in combination with first-line chemotherapy in the treatment of advanced non-small cell lung cancer.

The randomized, open-label, international trial will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in 840 patients with Stage IIIb/IV NSCLC.