MD Conference Express - ELCC 2015 - (Page 4)

FEATURED ARTICLES LUNG-MAP: MASTER PROTOCOL FOR CLINICAL TRIALS IN LUNG CANCER The Lung-MAP study [NCT02154490] represents a new model for clinical trials that will allow for the simultaneous testing of novel compounds and predictive biomarkers. Patients with squamous cell lung cancer will undergo NGS and then be matched to 1 of several phase 2 and 3 substudies of novel compounds against molecular targets (Figure 2), stated David R. Gandara, MD, University of California Davis Comprehensive Cancer Center, Davis, California, USA. Each substudy is designed for registration of new drug-biomarker combinations. The master protocol allows for 1 screening, registration, and testing process of patients; a rolling open and closing of each substudy, which is independent; a control group for each substudy; and the flexibility to amend the study as needed, such as when a new drug is approved. Lung-MAP, initiated in July 2014, is being conducted at about 500 sites in the National Clinical Trials Network, including Canada. It represents a unique public-private partnership between (1) the US National Cancer Institute, Southwest Oncology Group, Friends of Cancer Research, and Foundation for the National Institutes of Health, which handles the funding, and (2) pharmaceutical companies, which contribute about 20% of the usual cost of a phase 3 trial. This partnership resulted from a workshop led by the US National Cancer Institute to address the challenges of clinical trials in lung cancer because of its tumor heterogeneity and genomic complexity, which has led to mostly negative trials, the number of candidate molecular targets, and the slow pace for drug approvals with the classical approach to clinical trials. The master protocol approach also provides for developing drugs for genotypes that are rare or uncommon. Lung-MAP is anticipated to be self-sustaining, with new substudies being planned for new molecular targets and to adjust to the changing therapeutic landscape, stated Dr Gandara. Other studies using the master protocol approach are being conducted. 4 May 2015 The editors would like to thank the many members of the European Society for Medical Oncology 2015 European Lung Cancer Conference presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication. www.mdce.sagepub.com http://mdc.sagepub.com/

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MD Conference Express - ELCC 2015