| Summary: | <p>Abstract</p> <p>Background</p> <p>Even today, treatment of Stage III NSCLC still poses a serious challenge. So far, surgical resection is the treatment of choice. Patients whose tumour is not resectable or who are unfit to undergo surgery are usually referred to a combined radio-chemotherapy. However, combined radio-chemotherapeutic treatment is also associated with sometimes marked side effects but has been shown to be more efficient than radiation therapy alone.</p> <p>Nevertheless, there is a significant subset of patients whose overall condition does not permit administration of chemotherapy in a combined-modality treatment.</p> <p>It could be demonstrated though, that NSCLCs often exhibit over-expression of EGF-receptors hence providing an excellent target for the monoclonal EGFR-antagonist cetuximab (Erbitux<sup>®</sup>) which has already been shown to be effective in colorectal as well as head-and-neck tumours with comparatively mild side-effects.</p> <p>Methods/design</p> <p>The NEAR trial is a prospective phase II feasibility study combining a monoclonal EGF-receptor antibody with loco-regional irradiation in patients with stage III NSCLC. This trial aims at testing the combination's efficacy and rate of development of distant metastases with an accrual of 30 patients.</p> <p>Patients receive weekly infusions of cetuximab (Erbitux<sup>®</sup>) plus loco-regional radiation therapy as intensity-modulated radiation therapy. After conclusion of radiation treatment patients continue to receive weekly cetuximab for 13 more cycles.</p> <p>Discussion</p> <p>The primary objective of the NEAR trial is to evaluate toxicities and feasibility of the combined treatment with cetuximab (Erbitux<sup>®</sup>) and IMRT loco-regional irradiation.</p> <p>Secondary objectives are remission rates, 3-year-survival and local/systemic progression-free survival.</p>
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