Review of ongoing clinical trials in non-small-cell lung cancer: A status report for 2012 from the web site

Janakiraman Subramanian, Thomas Regenbogen, Gayathri Nagaraj, Alex Lane, Siddhartha Devarakonda, Gongfu Zhou, Ramaswamy Govindan

Research output: Contribution to journalReview articlepeer-review

27 Scopus citations


INTRODUCTION:: 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 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 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.

Original languageEnglish
Pages (from-to)860-865
Number of pages6
JournalJournal of Thoracic Oncology
Issue number7
StatePublished - Jul 2013


  • Lung cancer
  • Non-small-cell lung cancer
  • Ongoing studies


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