First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.

Carbone, David P, MD, PhD
Reck, Martin, MD, PhD
Paz-Ares, Luis, MD
Creelan, Benjamin, MD
Horn, Leora, MD
Steins, Martin, MD, PhD
Felip, Enriqueta, MD
van den Heuvel, Michel M, MD
Ciuleanu, Tudor-Eliade, MD
Badin, Firas, MD
Ready, Neal, MD
Hiltermann, T Jeroen N, MD
Nair, Suresh G., MD
Juergens, Rosalyn, MD, PhD
Peters, Solange, MD, PhD
Minenza, Elisa, MD
Wrangle, John M, MD
Rodriguez-Abreu, Delvys, MD
Borghaei, Hossein, DO
Blumenschein Jr, George R, MD
Villaruz, Liza C, MD
Havel, Libor, MD
Krejci, Jana, MD
Corral Jaime, Jesus, MD
Chang, Han, PhD
Geese, William J, PhD
Bhagavatheeswaran, Prabhu, PhD
Chen, Allen C, MD
Socinski, Mark A, MD

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Publication date

June 2017

Publisher

LVHN Scholarly Works

Language

English

Abstract

BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of dise...