Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Exclusion Criteria

• •1. Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement
• •2. Left ventricular ejection fraction (LVEF) less than 45%
• •3. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
• •4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
• •5. History of corneal disease
• •6. History of interstitial lung disease (ILD)
• •7. Clinically active brain metastases
• •8. Uncontrolled hypertension
• •9. Clinically significant ECG changes
• •10. Clinically significant (in the opinion of the Investigator) ascites or pleural effusion requiring chronic medical intervention
• •11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
• •12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
• •13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
• •14. Participation in clinical drug trials within 4 weeks
• •15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
• •16. History of hypersensitivity to any of the study drugs or to any excipients.