Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
About this trial
This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Non-Small Lung Cancer
Eligibility Criteria
Inclusion Criteria: Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva). Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease. Must be able to carry out work of light or sedentary nature (e.g. light house work, office work). It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest. Exclusion Criteria: Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to study drug administration. Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial). Symptomatic or uncontrolled metastases in the central nervous system (CNS). Peripheral neuropathy. Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL. Inadequate liver function. Inadequate kidney function.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
A
B