MONET1-MOtesanib NSCLC Efficacy and Tolerability Study

Summary

To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).

Timeline

Start

2007-07

Primary completion

2011-03

Completion

2013-08

Publications

• Background Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, Pirker R, Galiulin R, Ciuleanu TE, Sydorenko O, Dediu M, Papai-Szekely Z, Banaclocha NM, McCoy S, Yao B, Hei YJ, Galimi F, Spigel DR. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol. 2012 Aug 10;30(23):2829-36. doi: 10.1200/JCO.2011.41.4987. Epub 2012 Jul 2.
• Background Bass MB, Yao B, Hei YJ, Ye Y, Davis GJ, Davis MT, Kaesdorf BA, Chan SS, Patterson SD. Challenges in developing a validated biomarker for angiogenesis inhibitors: the motesanib experience. PLoS One. 2014 Oct 14;9(10):e108048. doi: 10.1371/journal.pone.0108048. eCollection 2014.
• Background Novello S, Scagliotti GV, Sydorenko O, Vynnychenko I, Volovat C, Schneider CP, Blackhall F, McCoy S, Hei YJ, Spigel DR. Motesanib plus carboplatin/paclitaxel in patients with advanced squamous non-small-cell lung cancer: results from the randomized controlled MONET1 study. J Thorac Oncol. 2014 Aug;9(8):1154-61. doi: 10.1097/JTO.0000000000000227.
• Kubota K, Ichinose Y, Scagliotti G, Spigel D, Kim JH, Shinkai T, Takeda K, Kim SW, Hsia TC, Li RK, Tiangco BJ, Yau S, Lim WT, Yao B, Hei YJ, Park K. Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis. Ann Oncol. 2014 Feb;25(2):529-36. doi: 10.1093/annonc/mdt552. Epub 2014 Jan 13.

Drugs

Indications