Inclusion criteria:

- Pathologically or cytologically confirmed NSCLC

- Stage IV Cancer (includes cytologically proven pleural effusion or pericardial
effusion) or recurrent disease. The staging is based on AJCC TNM classification of
malignant tumors, 7th edition

- Evidence of common EGFR activating mutations (Del 19 and/or L858R)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3

- Adequate organ function, defined as all of the following:

- Absolute neutrophil count (ANC) > 1500 / mm3

- Platelet count >75,000 / mm3.

- Baseline creatinine of < or = 1.5 g/dl or, if > 1.5, an estimated creatinine
clearance of > 45 ml/min

- Total Bilirubin < 1.5 times upper limit of institutional normal (ULN)

- Aspartate amino transferase (AST) or alanine amino transferase (ALT) < three times
ULN (if related to liver metastases < five times ULN)

- Recovery from any previous therapy related toxicity to< or = Grade 1 at study entry
(except for stable sensory neuropathy < or =Grade 2 and alopecia)

- Life expectancy of at least three months

- Written informed consent that is consistent with ICH-GCP guidelines

- Age 18 or older

Exclusion criteria:

- Prior participation in an afatinib clinical study, even if not assigned to afatinib
treatment

- Prior systemic therapy for metastatic or recurrent NSCLC including prior treatment
with EGFR targeting small molecules or antibodies. . Note: radiotherapy alone and
adjuvant/neoadjuvant treatment is not counted as a line of therapy.

- 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:

i.) Palliative radiation to target organs other than chest may be allowed up to 2
weeks prior to study treatment, or ii.) Single dose palliative treatment (e.g SRS or
SBRT) 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

- Women of child-bearing potential (WOCBP) and men who are able to father a child, or
use adequate contraception prior to study entry, for the duration of study
participation and for at least 28 days after treatment has ended.

- Presence of an active infection or with a fever > 38.5 C within 3 days of the first
scheduled day of dosing

- Known hypersensitivity to afatinib or the excipients of afatinib

- Known pre-existing interstitial lung disease

- Pathologically documented meningeal carcinomatosis (i.e. cytology (+) lumbar puncture
; radiology reports alone raising this as a possibility, in the absence of true
symptomatology, would not constitute an exclusion)

- Presence of brain or subdural metastases, unless local therapy has been completed and
use of corticosteroids has been discontinued or the dose has been stable for at least
4 weeks before starting study treatment. Any symptoms attributed to brain metastases
must be stable for at least 4 weeks before starting study treatment (Pts post SRS can
be enrolled earlier as long as their symptoms are stable or improved and they are off
steroids)

- 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 2 years
and is considered to be cured

- History or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure NYHA classification of 3 or 4
unstable angina or poorly controlled arrhythmia as determined by the investigator.
Myocardial infarction within 6 months prior to treatment with afatinib.

- Any history or presence of poorly controlled gastrointestinal disorders that could
affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis,
chronic diarrhoea, malabsorption)

- Known or suspected active hepatitis B infection (defined as presence of HepB sAg and/
or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or
known HIV carrier

- Any history of or concomitant condition that, in the opinion of the Investigator,
would compromise the patient's ability to comply with the study or interfere with the
evaluation of the safety and efficacy of the test drug

- Treatment with any of the prohibited concomitant medications that cannot be stopped
for the duration of trial participation

Minimum Eligible Age: 18 Years

Maximum Eligible Age: N/A

Eligible Gender: Both