Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria:

* Age 18 years.
* Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
* Measurable disease.
* Written informed consent must be obtained prior to the inclusion into the trial.
* Karnofsky performance status of 80%.
* Patients must have been treated with no prior chemotherapy or radioterapy.
* Patients must have adequate bone marrow, liver and renal function.

  * Bone Marrow: WBC \> 3000 x 103/mm3,
  * Platelets \> 100 x 103/mm3,
  * Hgb \> 10.0 gm/dl,
  * ANC \>1500 x 103/mm3,
  * Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
  * Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

* Female patients who are pregnant or lactating.
* Patients who have used other investigational agents within 21 days prior to study entry.
* Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
* Significant comorbidity.