Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Upon determination of eligibility all patients will receive:

• Docetaxel + Gemcitabine + Cetuximab

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

• 18 years of age or older
• Non-small cell lung cancer confirmed by biopsy
• Unresectable stage III or IV disease
• Measurable disease
• Must not have received any prior chemotherapy for lung cancer
• Able to perform activities of daily living without considerable assistance
• Adequate bone marrow, kidney, and liver function
• Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

• History of serious heart disease within six months prior to study entry
• Prior treatment with agents that target the EGFR pathway
• History of any other uncontrolled or significant disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.