INTRODUCTION: Treatment outcomes in unselected patients with advanced NSCLC 
remain disappointing with platinum-based chemotherapy. The addition of 
monoclonal antibodies targeting EGFR to standard first-line therapy is a 
validated strategy and has been associated with statistically significant 
survival advantage in advanced NSCLC. Necitumunab is a fully human IgG1 
monoclonal antibody targeting EGFR, having the potential benefit of lower 
hypersensitivity reaction risk as compared with cetuximab and also equivalent 
antibody-dependent cell-mediated cytotoxicity.
AREAS COVERED: This paper reviews literature on preclinical and early clinical 
development of necitumumab that is available in PubMed and published abstracts 
from conferences, as well as ongoing trials as specified by clinicaltrials.gov. 
Recently, the Phase III clinical trial evaluating the addition of necitumumab to 
pemetrexed and cisplatin in non-squamous NSCLC was prematurely closed due to 
concerns about the increased risk of thromboembolic events in the experimental 
arm. Accrual in the Phase III trial of necitumumab in combination with 
gemcitabine and cisplatin in squamous NSCLC is ongoing.
EXPERT OPINION: Results of the ongoing large randomized trials will be 
instrumental in determining the drug's clinical significance and, with the 
analysis of potential molecular predictive factors, are expected to bring 
valuable additions to future therapeutic strategies in NSCLC.