The Phase III trial of 956 patients is designed to compare the overall survival of patients taking Sutent (sunitinib) in combination with Tarceva (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.
In addition, preliminary results from a Phase II study evaluating the safety and tolerability of sunitinib combined with erlotinib in patients with advanced non-small cell lung cancer (NSCLC), found that adverse events were mild to moderate. Two patients experienced partial responses, while two patients experienced stable disease.
“We are encouraged by the early data we are seeing for sunitinib in NSCLC,” said Charles Baum, head of oncology development at Pfizer. “Pfizer is committed to further exploring the potential role of sunitinib in advanced NSCLC through the initiation of SUN 1087, a global, Phase III study.”
Lung cancer is the leading cause of cancer in men and women around the globe. Nearly 60% of NSCLC patients are diagnosed late with Stage IIIB/IV advanced disease and most have evidence of distant metastases at the time of diagnosis.