TY - JOUR
T1 - Treatment rationale study design for the MetLung trial
T2 - 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
AU - Spigel, David R.
AU - Edelman, Martin J.
AU - Mok, Tony
AU - O'Byrne, Kenneth
AU - Paz-Ares, Luis
AU - Yu, Wei
AU - Rittweger, Karen
AU - Thurm, Holger
N1 - Copyright © 2012. Published by Elsevier Inc.
PY - 2012/11
Y1 - 2012/11
N2 - 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.
AB - 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.
KW - Biomarkers
KW - Onartuzumab
KW - Second/third-line therapy
UR - http://www.scopus.com/inward/record.url?scp=84867526394&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000310411400015&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1016/j.cllc.2012.05.009
DO - 10.1016/j.cllc.2012.05.009
M3 - Article
C2 - 23063071
SN - 1525-7304
VL - 13
SP - 500
EP - 504
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 6
ER -