PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB

To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

Inclusion Criteria:

• Advanced Non-Small Cell Lung Cancer (NSCLC)
• Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
• Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
• Measurable disease .
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Tissue available for KRAS/ EGFR testing
• Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

Exclusion Criteria:

• Chemotherapy
• Radiotherapy
• Biological or investigational agents within 4 weeks of baseline disease assessment.
• Patients who lack of tolerance of erlotinib therapy.