title: Review of ongoing clinical trials in non-small-cell lung cancer: a status report for 2012 from the ClinicalTrials.gov Web site.
abstract: BACKGROUND
  Clinical research in non-small-cell lung cancer (NSCLC) is a rapidly evolving field. In an effort to identify the current trends in lung cancer clinical research, we reviewed ongoing clinical trials in NSCLC listed in the ClinicalTrials.gov registry in 2012, and we also compared this data to a similar survey conducted by us in 2009.
  
  
  METHODS
  The Web site's advanced search function was used to search for the term "non-small cell lung cancer." The search was further refined by using the following options from the search page drop-down menu, "open studies" and "interventional." Studies with non-NSCLC tumor histologies and pediatric studies were excluded.
  
  
  RESULTS
  Of the 477 trials included in the analysis, 105 (22.0%) were phase I, 223 phase II (46.8%), and 63 phase III trials (13.2%). When compared with data from 2009, university-sponsored trials decreased in number (45.4%-34.2%; p < 0.001) whereas industry-sponsored trials remained almost the same. There was a significant increase in trials conducted exclusively outside of the United States (35.9%-48.8%; p = 0.001). The number of studies with locations in China (61, 12.8%) was second only to that in the United States (244, 51.2%). Studies reporting biomarker analysis increased significantly from 37.5% to 49.1% in 2012 (p < 0.001). Biomarker-based patient selection also increased significantly from 7.9% to 25.8% (p < 0.001). Targeted therapies were evaluated in 70.6% of phase I/II and II trials, and the most common class of targeted agent studied was epidermal growth factor receptor tyrosine kinase inhibitors (38.0%). Prespecified accrual times were observed to increase when compared with data reported in 2009, especially among industry-sponsored studies.
  
  
  CONCLUSIONS
  Our survey identified major changes in lung cancer clinical research since 2009. Almost half of all studies registered at the ClinicalTrials.gov Web site are being conducted outside the United States, and several novel molecularly targeted agents are being evaluated in the treatment of patients with NSCLC. More importantly, we identified a threefold increase in the number of studies that perform biomarker testing to determine patient selection over the last 3 years.
authors.affiliation: Department of Medicine, University of Tennessee Medical Center, Knoxville, Tennessee, USA.
authors.forename: Janakiraman
authors.initials: J
authors.lastname: Subramanian
authors.forename: Thomas
authors.initials: T
authors.lastname: Regenbogen
authors.forename: Gayathri
authors.initials: G
authors.lastname: Nagaraj
authors.forename: Alex
authors.initials: A
authors.lastname: Lane
authors.forename: Siddhartha
authors.initials: S
authors.lastname: Devarakonda
authors.forename: Gongfu
authors.initials: G
authors.lastname: Zhou
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D006801:Humans; D008175:Lung Neoplasms / Q000628:therapy*