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Zactima, ZD6474/vandetanib/3rd/4th line treatment for NSCLC


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AstraZeneca announced the start of enrollment into a new Phase III study of the novel once-daily oral anti-cancer drug vandetanib (Zactima,ZD6474) as third/fourth line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed following EGFR TKI therapy.

Study 44 will be conducted at 208 centers across 23 countries worldwide, and is expected to enroll more than 930 patients. It will evaluate overall survival with vandetanib 300mg plus best supportive care (BSC) compared with placebo plus BSC in patients with advanced NSCLC, who have previously received treatment with chemotherapy and an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The study will also assess progression free survival, objective response rate, disease control rate, duration of response, effect on disease related symptoms, and safety and tolerability of vandetanib.

Principal Investigator Dr. Jin Soo Lee, National Cancer Centre, Gyeonggi, Korea, commented, "There are currently very limited treatment options available for patients after their cancer has progressed on second line treatment. Phase II studies have demonstrated promising anti-tumor efficacy with vandetanib in lung cancer, and Study 44 will now investigate if this multi-targeted agent can improve outcomes for patients."

Study 44 forms part of an extensive ongoing clinical development program of vandetanib in NSCLC and is the third Phase III study for vandetanib in NSCLC to have begun patient enrollment this year.

Vandetanib works by inhibiting both the development of the tumor's blood supply through inhibition of VEGFR (antiangiogenesis) and the growth and survival of the tumor itself through inhibition of EGFR.

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