An international, randomized, placebo-controlled, double-blind phase III study (MONET1) of motesanib plus carboplatin/paclitaxel (C/P) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).

• DOI: 10.1200/jco.2011.29.18_suppl.lba7512
• Publication Date: 2017-02-23T18:42:09Z
• Authors: G. Scagliotti; I. Vynnychenko; Y. Ichinose; K. Park; K. Kubota; F. H. Blackhall; R. Pirker; R. Galiulin; T. Ciuleanu; O. Sydorenko; M. Dediu; Z. Papai-Szekely; N. Martinez Banac...; S. McCoy; B. Yao; Y. J. Hei; D. R. Spigel
• Keywords: Clinical endpoint; Carboplatin

LBA7512 Background: This study evaluated whether motesanib (a selective oral inhibitor of VEGFR 1, 2 and 3; PDGFR Kit) plus C/P improved overall survival (OS) compared with placebo + in patients (pts) nonsquamous NSCLC a subset pts adenocarcinoma. Methods: Pts had stage IIIB/IV or recurrent no prior systemic therapy for advanced NSCLC. The initially enrolled all histologies but was amended to exclude squamous owing high rate hemoptysis. were randomized 1:1 receive up six 3-wk cycles C (AUC 6 mg/mL·min) P (200 mg/m ) either 125 mg QD (Arm A) B) orally continuously. primary endpoint OS; secondary endpoints included progression-free (PFS), adverse events (AEs), objective response (ORR) association between placental growth factor (PLGF) change OS. OS using stratified Cox model 2-sided log-rank test (α=0.03 α=0.02 adenocarcinoma pts). Results: 1090 A/B, n=541/549); 890 (n=448/442). 61% men; median age 60 years (range 21–87); 83% IV disease. At the time analysis, 753 died (608 adenocarcinoma). Median follow-up 10.6 mo. not significantly Arm A B (Table). In A, PLGF analysis did show an incidence grade ≥3 AEs Arms A/B 73/59%. Grade occurring more frequently than neutropenia (22/15%), diarrhea (9/1%), hypertension (7/1%) cholecystitis (3/0%). 5 14/9% A/B. Conclusions: NSCLC, treatment improve alone. [Table: see text]