Biomarkers Impact On the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Positive Mutation - BIOTEC
Inclusion Criteria:
- Adult patients, >=18 years of age
- Histological documented adenocarcinoma, locally advanced - stage IIIB, metastatic -
stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy >=12 weeks
- Evidence of disease with at least one measurable disease criteria as evaluated by
Response Evaluation Criteria in Solid Tumors (RECIST)
- Adequate haematological, liver and renal function
Exclusion Criteria:
- Known hypersensitivity to erlotinib or any of its excipients
- Squamous non-small cell or small cell tumors or absence of histological report
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
- Prior exposure to inhibitors of Epidermal Growth Factor Receptor (EGFR)
- Prior chemotherapy or treatment with another systemic anti-cancer agent for the
treatment of the patient's current stage of disease
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögrens syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions
- Radical radiotherapy with curative intent within 28 days prior to enrolment
- Any active non-controlled systemic disease