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

Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.

STUDY OBJECTIVES

Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva

Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

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.