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

Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

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.