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www.fdanews.com/articles/98222-pfizer-announces-phase-iii-non-small-cell-lung-cancer-trial

Pfizer Announces Phase III Non-Small Cell Lung Cancer Trial

September 7, 2007

Pfizer has begun a global Phase III trial of sunitinib malate in combination with erlotinib in previously treated patients with advanced non-small cell lung cancer.

The randomized, double-blind trial of 956 patients will compare the overall survival of patients taking sunitinib plus erlotinib 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.

Pfizer recently presented preliminary results from lead-in safety group in Phase II trials. In the trial, adverse events from 12 patients were mild-to-moderate, with the most frequent adverse events being diarrhea and fatigue.

Two patients had experienced a partial response and two patients experienced stable disease for more than 16 weeks, the company added.