A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

• Overall safety profile for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
• Patient Reported Outcomes (PRO) of health related quality of life and disease/treatment related symptoms for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• KRAS and HER family mutations in circulating tumor DNA in blood and in tissue (from original diagnostic or recently obtained sample) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
• Best Overall Response per RECIST (BOR) for patients in each arm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
• Duration of Response for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• Overall Survival for patients in each arm [ Time Frame: 16 months ] [ Designated as safety issue: No ]
• Pre and post treatment levels of circulating shed receptors of the HER signaling pathways or protein/receptors which interact with or are part of HER signaling pathway [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• EGFR mutations, including T790M, in blood at baseline and at end of study [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• Trough concentrations of PF 00299804 after repeated dosing; [ Time Frame: 13months ] [ Designated as safety issue: No ]

• Trough concentrations of PF 00299804 after repeated dosing; [ Time Frame: 13months ] [ Designated as safety issue: No ]
• Overall safety profile for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
• Patient Reported Outcomes (PRO) of health related quality of life and disease/treatment related symptoms for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• KRAS and HER family mutations in circulating tumor DNA in blood and in tissue (from original diagnostic or recently obtained sample) [ Time Frame: 16 monhts ] [ Designated as safety issue: No ]
• Best Overall Response per RECIST (BOR) for patients in each arm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
• Duration of Response for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• Overall Survival for patients in each arm [ Time Frame: 16 months ] [ Designated as safety issue: No ]
• Pre and post treatment levels of circulating shed receptors of the HER signaling pathways or protein/receptors which interact with or are part of HER signaling pathway [ Time Frame: 13 months ] [ Designated as safety issue: No ]
• EGFR mutations, including T790M, in blood at baseline and at end of study [ Time Frame: 13 months ] [ Designated as safety issue: No ]

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

• Drug: Erlotinib
  Continuous oral dosing at 150 mg daily.
• Drug: PF-00299804
  Continuous oral dosing at 45mg daily

• Active Comparator: A
  Intervention: Drug: Erlotinib
• Experimental: B
  Intervention: Drug: PF-00299804

Inclusion Criteria:

• advanced measurable Non-Small Cell Lung Cancer (NSCLC);
• progressed after 1-2 prior chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) 0-2;
• tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

• prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
• active or untreated Central Nervous System (CNS) metastases;