CONCURRENT CHEMOTHERAPY + CETUXIMAB VS CHEMOTHERAPY IN ADVANCED NSCLC

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是：1)通过化疗联合西妥昔单抗（并发vs序贯）的II期选择设计，选择基于总生存期的方案，用于III期ib期和IV期NSCLC单独化疗的III期测试；2)评估缓解率（确诊和未确诊）；选定IIIB期和IV期NSCLC患者全部和部分接受紫杉醇和卡铂联合西妥昔单抗或紫杉醇和卡铂联合西妥昔单抗治疗，3)评估两种治疗方案对选定IIIB期和IV期NSCLC患者的毒性。次要目标是对EGFR- her信号通路激活的磷酸化蛋白、致癌突变以及患者组织中增殖和凋亡率进行探索性分子相关性研究，并评估EGFR多态性与西妥昔单抗应答的潜在相关性。

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.