AstraZeneca enrolls vandetanib Ph III trial in NSCLC

Anglo-Swedish drug major AstraZeneca has completed patient enrollment in two pivotal Phase III studies for vandetanib, the company's investigational, once-daily oral anticancer drug, for the second-line treatment of non-small cell lung cancer. The two studies - ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) and ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) - are the second and third of four ongoing studies to complete enrollment. Data from the studies are expected later this year and the broad development program is on track for a first regulatory submission in 2008.

ZODIAC is a randomized, double-blind, international, multi-center Phase III study to assess the efficacy of vandetanib 100mg once-daily plus the standard docetaxel chemotherapy versus docetaxel alone in 1,380 patients with locally-advanced or metastatic NSCLC after failure of first-line anticancer therapy.

ZEAL is a Phase III parallel-group, randomized, double-blind study evaluating vandetanib 100mg once-daily plus pemetrexed 500mg/m2 (every three weeks) compared with placebo plus pemetrexed as second-line treatment in 510 patients with locally advanced or metastatic NSCLC who have failed first-line anticancer therapy.