A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

Lead Sponsor

Hoffmann-La Roche

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Adult patients ≥ 18 years of age.
•Histologically documented non-small cell lung cancer (NSCLC).
•Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
•Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
•Patients of reproductive potential must agree to use effective contraception.

•Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
•Prior treatment with any monoclonal antibody therapy.
•Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
•Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
•Pre-existing interstitial lung disease.
•Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
•Pregnant or lactating women.