Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development.

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Presentation transcript:

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 Shakun M. Malik, MD, Richard Pazdur, MD, Jeffrey S. Abrams, MD, Mark A. Socinski, MD, William T. Sause, MD, David H. Harpole, MD, John J. Welch, MD, PhD, Edward L. Korn, PhD, Claudio Dansky Ullmann, MD, Fred R. Hirsch, MD PhD Journal of Thoracic Oncology Volume 9, Issue 10, Pages 1443-1448 (October 2014) DOI: 10.1097/JTO.0000000000000314 Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 ALCHEMIST study schema. ALCHEMIST—A151216, screening trial; ALCHEMIST—EGFR A081105, erlotinib treatment arm; ALCHEMIST—ALK E4512, crizotinib treatment arm. Journal of Thoracic Oncology 2014 9, 1443-1448DOI: (10.1097/JTO.0000000000000314) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Phase II/III biomarker-driven master protocol for second-line therapy of squamous cell lung cancer (Lung-MAP Trial). *Archival formalin-fixed paraffin-embedded (FFPE) tumor, fresh core needle biopsy if needed. **CT = chemotherapy (docetaxel) control arm. ***E = erlotinib control arm. ****Substudy assignment will be determined based on randomization for patients eligible for multiple substudies. Journal of Thoracic Oncology 2014 9, 1443-1448DOI: (10.1097/JTO.0000000000000314) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions