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Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Date:9/21/2007

- Phase III trials now underway to evaluate vandetanib as second-line NSCLC

treatment in combination with docetaxel -

WILMINGTON, Del., Sept. 20 /PRNewswire/ -- Results published today in the Journal of Clinical Oncology(1) show that the AstraZeneca investigational once-daily oral anti-cancer drug vandetanib (ZACTIMA), in combination with docetaxel, improved progression free survival (PFS) in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The Phase II trial - Study 6 - compared the combination of vandetanib 100mg or 300mg plus docetaxel to standard docetaxel alone. The trial demonstrated that adding vandetanib to standard docetaxel therapy prolonged median PFS to 18.7 weeks and 17 weeks respectively, compared to 12 weeks with docetaxel alone.(2)

"Given the poor prognosis in advanced non-small cell lung cancer, an increase in time to disease progression can be meaningful to patients," said Study 6 lead author John Heymach, Assistant Professor of Thoracic Head/Neck Medical Oncology at the University of Texas MD Anderson Cancer Centre . "The results of Study 6 provide encouraging support, and reinforce further investigation with ZACTIMA in combination with chemotherapy in Phase III trials."

Based on these data, AstraZeneca has initiated a Phase III trial, currently underway, to evaluate vandetanib and docetaxel in second-line treatment of non-small cell lung cancer. The ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer), trial is a randomised, double- blind study evaluating vandetanib 100mg in combination with docetaxel vs. docetaxel alone, in patients with locally advanced or metastatic NSCLC after failure of first-line treatment.

The study is recruiting and aims to enroll approximately 1400 patients worldwide at over 250 centers throughout Europe, North America, South America and Asia Pacific. The primary end points of the study are to assess PFS. Response rates and overall Sur
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SOURCE AstraZeneca
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