Ensayos clínicos

Inclusion Criteria

• Pathologically or cytologically confirmed non-small cell lung cancer
• Stage IV cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease
  • The staging is based on American Joint Commitee on Cancer Classification of Malignant Tumours 7th edition
• Evidence of common EGFR mutation (Del 19 and/or L858R)
• Age ≥ 70 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No prior systemic therapy for metastatic or recurrent non-small cell lung cancer
• Further inclusion criteria apply

Exclusion Criteria

• Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
• Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
• Radiotherapy within 4 weeks prior to start of study treatment, except as follows
  • Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment
  • Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling
• Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
• Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown)
• Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
• Further Exclusion Criteria Apply