Lung Cancer :: AstraZeneca announces New Phase III Study of Vandetanib for Lung Cancer

AstraZeneca (NYSE: AZN) announced the commencement of a new Phase III study of its new investigational once-daily orally administered drug, vandetanib (ZACTIMA(R), ZD6474).

Study 36 will investigate the addition of vandetanib to pemetrexed (Alimta(R)) as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first line anti-cancer treatment. Study 36 will be conducted across 20 countries worldwide, including 20 sites in the United States, and is expected to enroll at least 508 patients, with the first patient entering the trial in January 2007.

As its primary objective, Study 36 will evaluate progression-free survival with vandetanib 100mg plus pemetrexed 500mg/m(2) compared with pemetrexed 500mg/m(2) plus placebo in patients with advanced NSCLC, who have previously received anti-cancer treatment. The study will also assess overall survival, objective response rate, disease control rate, duration of response, effect on disease related symptoms, time to deterioration of disease-related symptoms, the safety and tolerability of vandetanib in combination with pemetrexed, and population pharmacokinetics of vandetanib.

“After treatment failure with initial therapy, response rates to further treatment are low in patients with advanced non-small cell lung cancer,” said Dr. Peter Langmuir, Medical Science Director for vandetanib at AstraZeneca. “The effect of combining novel targeted agents, such as vandetanib, with chemotherapy needs to be explored in order to further progress treatment options for patient benefit.”

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