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Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
Date:5/15/2013

(GC) as first-line treatment for Asian patients (pts) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung.  Poster discusison (Abstract #8016) at American Society of Clinical Oncology, Chicago, June 2, 2013.

[2]  Hanna, N., MD. LUME-Lung 2: A multicenter, randomized, double-blind, phase 3 study of nintedanib plus pemetrexed vs placebo plus pemetrexed in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy. Poster discussion (Abstract #8034) at American Society of Clinical Oncology, Chicago, June 2, 2013.

[3] Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer  Drugs and Biologics. May 2007. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf

[4]   National Center for Biotechnology Information (NCBI). Reporting disease control rates or clinical benefit rates in early clinical trials of anticancer agents: useful endpoint or hype? December 2010. Available at: http://www.ncbi.nlm.nih.gov/pubmed/21268434

[5] Geater, S.L., MD.  LUX-Lung 6: Patient reported outcomes (PROs) from a randomized open-label, Phase III study in 1st-line advanced NSCLC patients (pts) harboring epidermal growth factor receptor (EGFR) mutations. Poster (Abstract #8061) at American Society of Clinical Oncology, Chicago, June 1, 2013.

[6]   European Organisation for Research and Treatment of Cancer (EORTC). Glossary. Available at: http://groups.eortc.be/qol/glossary. Last accessed May 9, 2013.

[7]  Mayo Clinic. Elevated Liver Enzymes
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