AstraZeneca begins Ph III Zactima trial

Anglo-Swedish drug major AstraZeneca says that it has initiated a Phase III study of its drug Zactima (vandetanib), in combination with US drugmaker Eli Lilly's Alimta (pemetrexed), in patients with advanced non-small cell lung cancer. The trial will assess the combined regimen as a second-line therapy in subjects who have experienced at least one failed course of chemotherapy.

The firm explained that the assessment, which will seek to enroll at least 508 patients, will provide participants with either 100mg of Zactima plus 500mg/m2 of pemetrexed, or 500mg/m2 of pemetrexed and placebo, in an effort to determine the overall survival rate. In addition, the effect of the combined treatment on objective response rate, disease control and symptoms, as well as the duration of its impact, will be examined.

AstraZeneca said that the trial, referred to as study 36, is part of its wider clinical development program, which includes: a Phase III comparison of combined Zactima and docetaxel and docetaxal alone in NSCLC patients; a double-blind trial comparing the drug with erlotinib; and study 44, which is an examination of the agent in combination with best supportive care versus BSC as a fourth-line therapy for NSCLC sufferers.