A Randomized, Double-blind, Placebo-controlled Phase 3 Study of First-line Maintenance Tarceva vs Tarceva at the Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-based Chemotherapy

Inclusion Criteria:

- Adult patients, >/= 18 years of age (or >/= legal age of consent if greater than 18)

- Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung
cancer (NSCLC)

- Completion of 4 cycles of platinum-based chemotherapy without progression (end of
last chemotherapy cycle
- ECOG performance status 0-1

Exclusion Criteria:

- Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)

- Patients whose tumours harbour an EGFR activating mutation

- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced
disease before screening (platinum-based chemotherapy)

- Use of pemetrexed in maintenance setting (pemetrexed is allowed during the
chemotherapy run-in)

- Patients who have undergone complete tumour resection after responding to the
platinum-based chemotherapy during the screening phase

- Any other malignancies within 5 years, except for curatively resected carcinoma in
situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or
organ confined prostate cancer

- CNS metastases or spinal cord compression that has not been definitely treated with
surgery and/or radiation, or treated CNS metastases or spinal cord compression
without stable disease for >/= 2 months

- HIV, hepatitis B or hepatitis C infection

- Any inflammatory changes of the surface of the eye