This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives of this study are to 1) select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs sequential) for Phase III testing against chemotherapy alone in stage IIIB & stage IV NSCLC, 2) evaluate response rates (confirmed & unconfirmed, complete & partial) of patients with selected stage IIIB & stage IV NSCLC treated with paclitaxel & carboplatin with concurrent cetuximab or paclitaxel & carboplatin followed by cetuximab and 3) evaluate the toxicities of the 2 treatment regimens in patients with selected stage IIIB & stage IV NSCLC. The secondary objectives are to conduct explatory molecular correlative studies of the EGFR-HER signaling pathways activated phosphoproteins, oncogenic mutations & rates of proliferation & apoptosis in patients tissues & evaluate EGFR polymorphisms as a potential correlate for response to cetuximab.
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