Pfizer Lung Cancer Drug Enters Phase III

Pfizer has initiated a large, global Phase III trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small cell lung cancer (NSCLC).

Preliminary results from a Phase II study on the safety and tolerability of sunitinib in combination with erlotinib in patients with advanced NSCLC, indicate that adverse events were mild to moderate in severity. Also, two patients experienced a partial response (PR); one patient demonstrated a PR after two cycles of therapy, which was maintained for more than three months, and the second patient has a documented durable PR and continues on the study.

The Phase III, randomized, double-blind trial of 956 patients is designed to compare the overall survival of patients taking sunitinib combined with erlotinib (a targeted therapy used to treat NSCLC) with those taking erlotinib plus placebo. Secondary endpoints of the study include progression-free survival, objective response rate, one-year survival, duration of response, adverse events and patient-reported outcomes.