A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small
cell lung cancer (NSCLC)

- Presence of epidermal growth factor receptor (EGFR) mutations

- Previously untreated with any systemic anti-neoplastic therapy for advanced disease

- Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >/= 4
weeks before study start, and patient recovered from acute toxicities of any previous
therapy

Exclusion Criteria:

- Pregnant or breast feeding women

- Known allergy or other adverse reaction to study drug or any other related compound

- Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule
or monoclonal antibody therapy)

- Newly diagnosed or not yet definitively treated (i.e. stable disease >/= 2 months)
CNS metastases or spinal cord compression

- Any significant ophthalmological abnormality, especially those likely to increase the
risk of corneal epithelial lesions (the use of contact lenses is not recommended
during the study)

- Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of
the skin that have been excised and cured