Biomarker Clinical Trials in Lung Cancer: Design, Logistics, Challenges, and Practical Considerations

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5 Scopus citations


Treatment for lung cancer has evolved in the past 3 decades starting with platinum-based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker-driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early-phase biomarker discovery to proof-of-concept trials to definitive trials. We also present some thoughts on future directions.

Original languageEnglish (US)
Pages (from-to)1625-1637
Number of pages13
JournalJournal of Thoracic Oncology
Issue number11
StatePublished - Nov 2018


  • Biomarker designs
  • Clinical trials
  • Logistical challenges
  • Lung cancer
  • Practical considerations

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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