Cited by 2,503Cancer Immunotherapy and BiomarkersLung Cancer Treatments and MutationsLung Cancer Diagnosis and Treatment

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

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Carbone, David P., Reck, Martin, Paz-Ares, Luis, Creelan, Benjamin, Horn, Leora, Steins, Martin, Felip, Enriqueta, van den Heuvel, Michel M., Ciuleanu, Tudor-Eliade, Badin, Firas, Ready, Neal, Hiltermann, T. Jeroen N., Nair, Suresh, Juergens, Rosalyn, Peters, Solange, Minenza, Elisa, Wrangle, John M., Rodriguez-Abreu, Delvys, Borghaei, Hossein, Blumenschein, George R., Villaruz, Liza C., Havel, Libor, Krejci, Jana, Corral Jaime, Jesus, Chang, Han, Geese, William J., Bhagavatheeswaran, Prabhu, Chen, Allen C., Socinski, Mark A.·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1613493PMC PMC6487310

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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 disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more. RESULTS: Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy. CONCLUSIONS: Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, NCT02041533 .).

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Authors: Carbone, D. P., Reck, M., Paz-Ares, L., Creelan, B., Horn, L., Steins, M., Felip, E., van den Heuvel, M. M., Ciuleanu, T.-E., Badin, F., Ready, N., Hiltermann, T. J. N., Nair, S., Juergens, R., Peters, S., Minenza, E., Wrangle, J. M., Rodriguez-Abreu, D., Borghaei, H., Blumenschein, G. R., Villaruz, L. C., Havel, L., Krejci, J., Corral Jaime, J., Chang, H., Geese, W. J., Bhagavatheeswaran, P., Chen, A. C., & Socinski, M. A.
Affiliations: Universidad Complutense de Madrid (ES)
ORCID: Carbone, David P.
Reck, Martin
Paz-Ares, Luis
Horn, Leora
Felip, Enriqueta
Ciuleanu, Tudor-Eliade
Badin, Firas
Ready, Neal
Hiltermann, T. Jeroen N.
Nair, Suresh
Juergens, Rosalyn
Peters, Solange
Wrangle, John M.
Borghaei, Hossein
Blumenschein, George R.
Villaruz, Liza C.
Havel, Libor
Chang, Han
Geese, William J.
Socinski, Mark A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2017-06-22
Volume: 376
Issue: 25
Pages: 2415-2426
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1613493
PMC: PMC6487310
OpenAlex: W2635951006
Cited by: 2,503
References: 20
Citations by year: 2026: 54 · 2025: 121 · 2024: 196 · 2023: 223 · 2022: 328 · 2021: 380 · 2020: 432 · 2019: 372 · 2018: 334 · 2017: 61
FWCI: 144.69
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
SERVAL (Université de Lausanne) (publishedVersion, other-oa)
PubMed Central (acceptedVersion)
QUT ePrints (Queensland University of Technology) (submittedVersion)
IRIS (submittedVersion)
LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
Lirias (submittedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Radboud Repository (Radboud University) (submittedVersion)
VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Funders: National Cancer Institute (UG1CA233259, K12CA157688, P30CA016672, P30CA016058)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: nivolumab, non-small cell lung cancer, PD-L1 expression, first-line therapy, stage IV NSCLC, recurrent NSCLC, platinum-based chemotherapy, docetaxel, progression-free survival, overall survival, immune checkpoint inhibitors, treatment-related adverse events, PD-1 inhibitors, PD-L1 inhibitors, PD-1/PD-L1 blockade
MeSH terms: Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Disease-Free Survival, B7-H1 Antigen

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

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