A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

Inclusion Criteria:

- Adult patients aged >/=18 years

- inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node
metastases or malignant pleural or pericardial effusion) or metastatic (stage IV)
non-small cell lung cancer (NSCLC)

- Disease must be characterized according to Response Evaluation Criteria in Solid
Tumors (RECIST) criteria

- Patients have received one prior platinum-based chemotherapy regimen for advanced
NSCLC, but must have recovered from any treatment-related toxicity

- ECOG performance status 0-2

- Life expectancy >/=12 weeks

- Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and
currently smoking on average >/=1 cigarette per day), not intending to stop during
the study

Exclusion Criteria:

- Prior antibody or small molecule therapy against EGFR

- Radiotherapy within 28 days prior to enrolment

- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC