Trial Information

Summary: A Phase II Randomized Study of Erlotinib (Tarceva, OSI-774) as a Single Agent or Intercalated with Combination Chemotherapy in Patients with Advanced Non-small Cell Lung Cancer that have EGFR Overexpression and/or EGFR Amplification and/or Mutation

This will be the first prospective study where patients will be selected on the basis of three measures of the EGFR pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression, EGFR mutation and/or EGFR amplification.

Inclusion Criteria:

• Age >=18
• Histologically documented NSCSL ECOG PS or 0, 1, 2
• Clinically and/or radiologically measurable or evaluable disease 1 or 2
• EGFR pathway markers positive at screening

Exclusion Criteria:

• Any concurrent anticancer therapy or radiation
• Other active malignancy
• Uncontrolled brain metastases
• GI abnormalities
• Severe abnormalities of the cornea
• Significant cardiac disease
• Active infection

If you would like to learn more about participating in this study, please send an e-mail message using the form below.