A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients, >=18 years of age;
• advanced (stage IIIB/IV)non-small cell lung cancer;
• measurable disease;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Exclusion Criteria:

• prior exposure to agents directed at the HER axis;
• prior chemotherapy or systemic anti-tumor therapy after advanced disease;
• unstable systemic disease;
• any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
• brain metastasis or spinal cord compression.