A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

• Drug: Dacomitinib
  
  Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
• Drug: Dacomitinib
  
  Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.

• Experimental: Cohort A
  
  Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.
  Intervention: Drug: Dacomitinib
• Experimental: Cohort B
  
  Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
  Intervention: Drug: Dacomitinib

Inclusion Criteria:

• Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
• Evidence of T790M mutation to enroll in Cohort A.
• Evidence of measurable disease by radiographic technique.
• Adequate organ function.

Exclusion Criteria:

• Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
• Symptomatic brain metastases.
• Uncontrolled or significant cardiovascular disease.
• Pregnant or breastfeeding.