This is a single pivotal study designed to support applications to market ASA404 for lung cancer patients who have received one previous round of treatment. A separate, ongoing pivotal trial, Attract-1, is evaluating ASA404 in patients receiving their first treatment for non-small cell lung cancer (NSCLC). Worldwide rights to ASA404 were licensed to Novartis in April 2007.
Attract-2 is a randomized, double-blind, placebo-controlled, multi-center, multi-country Phase III trial that will include approximately 900 patients receiving their second treatment for stage IIIb/IV NSCLC of either squamous or non-squamous histology. It is open to patients who previously received only chemotherapy and to patients who received chemotherapy plus bevacizumab or cetuximab as their first-line treatment.
Patients will be randomly assigned to receive eitherdocetaxel or a placebo plus docetaxel. The primary endpoint of the trial is overall survival. Before the final analysis there will be a single interim look, which is expected to occur during 2010. The study is expected to be completed in 2011.
Glyn Edwards, CEO of Antisoma, said: “We’re delighted that our partner Novartis has decided to explore the potential of ASA404 in previously treated as well as newly diagnosed lung cancer patients. This will help to ensure that a wide range of patients could benefit from the drug.”