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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

vival (OS) will be evaluated as secondary endpoints in the study.

AstraZeneca is currently investigating vandetanib through an extensive NSCLC clinical trial program.

About Study 6

This randomized, double-blind, placebo -controlled Phase II trial evaluated the activity of vandetanib 100mg and 300mg in combination with standard docetaxel therapy (75 mg/m2 via intravenous infusion every 21 days) in 127 patients with advanced (stage IIIb/IV) NSCLC, including squamous cell carcinoma, after failure of first-line platinum-based chemotherapy.

Patients were randomized to vandetanib 100 mg + docetaxel (n=42), vandetanib 300 mg + docetaxel (n=44), or Docetaxel alone (n=41). The prolonged median progression-free survival (PFS) was 18.7 weeks (HR=0.64, 95% CI 0.38 - 1.05; p=0.074) and 17 weeks (HR=0.83, 95% CI 0.50-1.38; p=0.461) respectively, compared to 12 weeks with docetaxel alone.(2)

In this study, treatment with vandetanib was associated with asymptomatic QT prolongation (extended time interval between heartbeats). Other common adverse events (AEs) included diarrhea and rash. All AEs responded to standard management or dose interruption or reduction.

Due to the small number of patients involved, and the fact that survival data was potentially confounded by subsequent therapies, further assessment of survival outcomes will be investigated in Phase III trials. There was no significant effect of vandetanib on overall survival.

About Lung cancer

Over 1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2 million people die as a result of this devastating disease - more than breast, colon and prostate cancer combined.(3)

If lung cancer is detected at early stages, before it has spread to other organs or lymph nodes, around half of patients can survive for five years or more. However, few lung cancers are found at this early stage and it is normally diagnosed at the advanced stage, when five-year survi
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SOURCE AstraZeneca
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