An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Inclusion criteria

Patients with:

• locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
• Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
• Adequate organ function, defined as all of the following:
• Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
• Platelet count >75,000/mm3
• Serum creatinine < 1.5 times of the upper limit of normal
• Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
• Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN).
• Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
• written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria

Patients who or with:

• prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
• anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
• radiotherapy within 14 days prior to drug administration, except as follows:
• Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
• Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
• previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
• known pre-existing interstitial lung disease
• meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication)