title: 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.
abstract: 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.
authors.affiliation: *Clinical Investigations Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD; †Offices of Hematology and Oncology Products, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Silver Spring, MD; ‡University of Pittsburgh Medical Center, Pittsburgh, PA; §University of Utah, Salt Lake City, UT; ‖Duke University Medical Center, Durham, NC; ¶Biometric Research Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD; and #University of Colorado, School of Medicine, Denver, CO.
authors.forename: Shakun M
authors.initials: SM
authors.lastname: Malik
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Abrams
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.forename: William T
authors.initials: WT
authors.lastname: Sause
authors.forename: David H
authors.initials: DH
authors.lastname: Harpole
authors.forename: John J
authors.initials: JJ
authors.lastname: Welch
authors.forename: Edward L
authors.initials: EL
authors.lastname: Korn
authors.forename: Claudio Dansky
authors.initials: CD
authors.lastname: Ullmann
authors.forename: Fred R
authors.initials: FR
authors.lastname: Hirsch
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism*; D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D008175:Lung Neoplasms / Q000378:metabolism* / Q000628:therapy*; D054547:National Cancer Institute (U.S.); D016032:Randomized Controlled Trials as Topic / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D014408:Biomarkers, Tumor