Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

Inclusion Criteria:

• Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
• Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
• ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
• Tumor sample available and adequate for analysis.
• At least one measurable target lesion.
• Adequate cardiac, kidney, and liver function
• Adequate blood counts

Exclusion Criteria:

• More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
• Significant cardiac disease or dysfunction.
• Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
• Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
• Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
• Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
• Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
• Inability or unwillingness to swallow HKI-272 capsules.
• Pregnant or breastfeeding women.