Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung
cancer with mutations in the tyrosine kinase domain of the epidermal growth factor
receptor (EGFR)
- At least one measurable lesion according to RECIST criteria
- European Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, liver and renal function
- Patients with stable cerebral metastases who have received surgical or radiotherapy
will be eligible
Exclusion Criteria:
- Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or
adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before
entering the study)
- History of another neoplasm except for carcinoma in situ of the cervix, adequately
treated basal cell skin carcinoma, radically treated prostate carcinoma with good
prognosis (Gleason = 6), or another curatively treated neoplasm without evidence of
disease in the last 5 years
- Symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
- Use of coumarins
- Pregnant or breast-feeding women
- Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and
carcinomatosis (if this is the only presence of the disease)