Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.

Journal Article (Journal Article)

On February 2, 2012, the National Cancer Institute (NCI) sponsored a 2-day workshop with the NCI Thoracic Malignancies Steering Committee and the Food and Drug Administration to bring together leading academicians, clinicians, industry and government representatives to identify challenges and potential solutions in the clinical development of novel targeted therapies for lung cancer. Measures of success are rapidly evolving from a scientific and regulatory perspective and the objectives of this workshop were to achieve initial consensus on a high priority biomarker-driven clinical trial designed to rapidly assess the activity of targeted agents in molecularly defined lung cancer subsets and to facilitate generation of data leading to approval of these new therapies. Additionally, the meeting focused on identification of the barriers to conduct such a trial and the development of strategies to overcome those barriers. The "Lung Master Protocols" recently launched by NCI were the direct outcome of this workshop.

Full Text

Duke Authors

Cited Authors

  • Malik, SM; Pazdur, R; Abrams, JS; Socinski, MA; Sause, WT; Harpole, DH; Welch, JJ; Korn, EL; Ullmann, CD; Hirsch, FR

Published Date

  • October 2014

Published In

Volume / Issue

  • 9 / 10

Start / End Page

  • 1443 - 1448

PubMed ID

  • 25521397

Pubmed Central ID

  • PMC4165474

Electronic International Standard Serial Number (EISSN)

  • 1556-1380

Digital Object Identifier (DOI)

  • 10.1097/JTO.0000000000000314


  • eng

Conference Location

  • United States