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

A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.