Author(s): Kato T, Seto T, Nishio M, Goto K, Atagi S, et al.
Background: Resistance to first-generation or second-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy develops in almost half of patients with EGFR-positive non-small-cell lung cancer (NSCLC) after 1 year of treatment. The JO25567 phase 2 trial comparing erlotinib plus bevacizumab combination therapy with erlotinib monotherapy established the activity and manageable toxicity of erlotinib plus bevacizumab in patients with NSCLC. We did a phase 3 trial to validate the results of the JO25567 study and report here the results from the preplanned interim analysis.
Methods: In this prespecified interim analysis of the randomised, open-label, phase 3 NEJ026 trial, we recruited patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan. Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1). Patients were randomly assigned (1:1) to receive oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day monotherapy. Randomisation was done by minimisation, stratified by sex, smoking status, clinical stage, and EGFR mutation subtype. The primary endpoint was progression-free survival. This study is ongoing; the data cutoff for this prespecified interim analysis was Sept 21, 2017. Efficacy was analysed in the modified intention-to-treat population, which included all randomly assigned patients who received at least one dose of treatment and had at least one response evaluation. Safety was analysed in all patients who received at least one dose of study drug. The trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000017069.
Referred From: https://pubmed.ncbi.nlm.nih.gov/30975627/
Author(s): Quint LE, Tummala S, Brisson LJ, Francis IR, Krupnick AS, et al.
Author(s): Bohman L, Bassett L, Gold R, Voet R
Author(s): Amichetti M, Perani B, Boi S
Author(s): Lee SH, Park JM, Kook SH, Han BK, Moon WK
Author(s): Vergier B, Trojani M, De Mascarel I, Coindre JM, Le Treut A
Author(s): Mirrielees JA, Kapur JH, Szalkucki LM, Harter JM, Salkowski LR, et al.
Author(s): Dansin E, Carnot A, Servent V, Daussay D, Robin YM, et al.
Author(s): Ettinger DS, Wood DE, Akerley W, Bazhenova LA, Borghaei H, et al.
Author(s): Nielsen M, Ørnvold K, Andersen Ja, HenriksenFw, Kristensen Pb, et al.
Author(s): Vizcaino I, Torregrosa A, Higueras V, Morote V, Cremades A, et al.
Author(s): Huang HC, Hang JF, Wu MH, Chou TY, Chiu CH
Author(s): Babu KS, Roberts F, Bryden F, McCafferty A, Downer P, et al.
Author(s): Maounis N, Chorti M, Legaki S, Ellina E, Emmanouilidou A, et al.
Author(s): Park SY, Kim BH, Kim JH, Lee S, Kang GH
Author(s): Turner BM, Cagle PT, Sainz IM, Fukuoka J, Shen SS, et al.
Author(s): Zhu B, Dalal S, Kamp DW, Lin X
Author(s): Rusthoven KE, Hammerman SF, Kavanagh BD, Birtwhistle MJ, Stares M, et al.
Author(s): Yano T, Okamoto T, Haro A, Fukuyama S, Yoshida T, et al.
Author(s): Parikh RB, Cronin AM, Kozono DE, Oxnard GR, Mak RH, et al.
Author(s): Yano T, Haro A, Yoshida T, Morodomi Y, Ito K, et al.
Author(s): Ashworth AB, Senan S, Palma DA, Riquet M, Ahn YC, et al.
Author(s): Yoon MY, Song CS, Seo MH, Kim MJ, Oh TY, et al.