Treatment rationale study design for the MetLung trial : a randomized, double-blind phase III study of onartuzumab (MetMAb) in combination with erlotinib versus erlotinib alone in patients who have received standard chemotherapy for stage IIIB or IV met-positive non-small-cell lung cancer

Spigel, David R., Edelman, Martin J., Mok, Tony, O'Byrne, Kenneth J., Paz-Ares, Luis, Yu, Wei, Rittweger, Karen, & Thurm, Holger (2012) Treatment rationale study design for the MetLung trial : a randomized, double-blind phase III study of onartuzumab (MetMAb) in combination with erlotinib versus erlotinib alone in patients who have received standard chemotherapy for stage IIIB or IV met-positive non-small-cell lung cancer. Clinical Lung Cancer, 13(6), pp. 500-504.

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Abstract

We present the treatment rationale and study design of the MetLung phase III study. This study will investigate onartuzumab (MetMAb) in combination with erlotinib compared with erlotinib alone, as second- or third-line treatment, in patients with advanced non-small-cell lung cancer (NSCLC) who are Met-positive by immunohistochemistry. Approximately 490 patients (245 per treatment arm) will receive erlotinib (150 mg oral daily) plus onartuzumab or placebo (15 mg/kg intravenous every 3 weeks) until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death. The efficacy objectives of this study are to compare overall survival (OS) (primary endpoint), progression-free survival, and response rates between the 2 treatment arms. In addition, safety, quality of life, pharmacokinetics, and translational research will be investigated across treatment arms. If the primary objective (OS) is achieved, this study will provide robust results toward an alternative treatment option for patients with Met-positive second- or third-line NSCLC. © 2012 Elsevier Inc. All Rights Reserved.

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ID Code: 65713
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: Biomarkers, Onartuzumab, Second/third-line therapy, erlotinib, placebo, scatter factor receptor, adult, article, controlled study, double blind procedure, drug efficacy, drug safety, female, human, immunohistochemistry, lung non small cell cancer, major clinical study, male, multicenter study, overall survival, phase 3 clinical trial, progression free survival, quality of life, randomized controlled trial, treatment response
DOI: 10.1016/j.cllc.2012.05.009
ISSN: 1525-7304
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Education
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2012 Elsevier Inc.
Deposited On: 06 Jan 2014 06:44
Last Modified: 17 Mar 2014 01:24

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