New Phase III Trial of Zactima as 2nd-Line Rx for NSCLC

WILMINGTON, Delaware—AstraZeneca has initiated a new phase III study of its investigational once-daily oral agent vandetanib (Zactima, ZD6474), known as Study 36. It will compare vandetanib 100 mg plus pemetrexed (Alimta) 500 mg/m² against pemetrexed plus placebo as second-line treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of first-line anticancer treatment. Study 36 will be conducted across 20 countries, including 20 US sites, and is expected to enroll at least 508 patients. Progression-free survival is the primary endpoint.

Vandetanib is a multi-targeted compound that inhibits key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and REarranged during Transfection (RET) tyrosine kinases, while blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinases.

Study 36 is the fourth phase III study of vandetanib in NSCLC. The others are Study 32 comparing vandetanib plus docetaxel (Taxotere) vs docetaxel alone as second-line therapy; Study 57, comparing vandetanib monotherapy vs erlotinib (Tarceva) as second-line therapy; and Study 44, comparing vandetanib plus best supportive care (BSC) vs placebo plus BSC as third- and fourth-line treatment after failure with chemotherapy and an EGFR tyrosine kinase inhibitor.

To learn more, go to www.clinicaltrials.gov and enter the ID code NCT00418886, or call AstraZeneca (866-992-9276).