Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented, inoperable, locally advanced, recurrent
or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
- Non-small cell lung cancer with an EGFR activating mutation
- Patients must have evidence of disease, but measurable disease is not mandatory
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal and liver function
Exclusion Criteria:
- Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant
chemotherapy is allowed if completed within 6 months prior to enrolment. Prior
radiochemotherapy is allowed if completed more than 6 months before start of study
treatment
- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
- Any other malignancies within 5 years, except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin carcinoma
- Brain metastasis or spinal cord compression not yet definitely treated with surgery
and/or radiation
- Patients unable to take oral medication or requiring intravenous alimentation, with
prior surgical procedures affecting absorption or active peptic ulcer disease
- Any significant ophthalmologic abnormality, especially those likely to increase the
risk of corneal epithelial lesions; the use of contact lenses is not recommended
during the study
- Pregnant or breast-feeding women