Evidence map›Paper›PMID 37988950›Full record

Trial reportESMO open2023

Nivolumab plus chemotherapy in first-line metastatic non-small-cell lung cancer: results of the phase III CheckMate 227 Part 2 trial.

H Borghaei, K J O'Byrne, L Paz-Ares, T-E Ciuleanu, X Yu, A Pluzanski, A Nagrial, L Havel, R D Kowalyszyn, C A Valette and 9 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 13 pooled it
9.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 13 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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  14. Trial
  15. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  19. Current oncology (Toronto, Ont.) · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 9 countries.

H BorghaeiFox Chase Cancer Center, Philadelphia, USA. Electronic address: Hossein.Borghaei@fccc.edu.
K J O'ByrnePrincess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia.
L Paz-AresHospital Universitario 12 de Octubre, Universidad Complutense & CiberOnc, Madrid, Spain.
T-E CiuleanuInstitutul Oncologic Prof. Dr. Ion Chiricuţă and UNF Iuliu Haţieganu University, Cluj-Napoca, Romania.
X YuZhejiang Cancer Hospital, Hangzhou, China.
A PluzanskiMaria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
A NagrialBlacktown Hospital, Sydney, Australia.
L HavelThomayer Hospital, Charles University, Prague, Czech Republic.
R D KowalyszynClínica Viedma, Viedma, Argentina.
C A ValetteHôpital Sainte -Musse, Toulon, France.
J R BrahmerJohns Hopkins, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, USA.
M ReckLung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.
S S RamalingamWinship Cancer Institute, Emory University, Atlanta, USA.
L ZhangSun Yat-Sen University Cancer Center, Guangdong, China.
I NtambweBristol Myers Squibb, Princeton, USA.
S K RabindranBristol Myers Squibb, Princeton, USA.
F E NathanBristol Myers Squibb, Princeton, USA.
D BalliBristol Myers Squibb, Princeton, USA.
Y-L WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong, China.
Bristol-Myers Squibb (United States) · USBlacktown & Mount Druitt Hospital · AUCharles University · CZEmory University · USFox Chase Cancer Center · USGuangdong Academy of Medical Sciences · CNHôpital d'Instruction des Armées Sainte-Anne · FRHospital Universitario 12 De Octubre · ESInstitute of Oncology Prof. Dr. Ion Chiricuta · ROLungenClinic Grosshansdorf · DEQueensland University of Technology · AUSidney Kimmel Comprehensive Cancer Center · USSun Yat-sen University · CNThe Maria Sklodowska-Curie National Research Institute of Oncology · PLZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn CheckMate 227 Part 1, first-line nivolumab plus ipilimumab prolonged overall survival (OS) in patients with metastatic non-small-cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% versus chemotherapy. We report results from CheckMate 227 Part 2, which evaluated nivolumab plus chemotherapy versus chemotherapy in patients with metastatic NSCLC regardless of tumor PD-L1 expression. PATIENTS AND

methodsSeven hundred and fifty-five patients with systemic therapy-naive, stage IV/recurrent NSCLC without EGFR mutations or ALK alterations were randomized 1 : 1 to nivolumab 360 mg every 3 weeks plus chemotherapy or chemotherapy. Primary endpoint was OS with nivolumab plus chemotherapy versus chemotherapy in patients with nonsquamous NSCLC. OS in all randomized patients was a hierarchically tested secondary endpoint.

resultsAt 19.5 months' minimum follow-up, no significant improvement in OS was seen with nivolumab plus chemotherapy versus chemotherapy in patients with nonsquamous NSCLC [median OS 18.8 versus 15.6 months, hazard ratio (HR) 0.86, 95.62% confidence interval (CI) 0.69-1.08, P = 0.1859]. Descriptive analyses showed OS improvement with nivolumab plus chemotherapy versus chemotherapy in all randomized patients (median OS 18.3 versus 14.7 months, HR 0.81, 95.62% CI 0.67-0.97) and in an exploratory analysis in squamous NSCLC (median OS 18.3 versus 12.0 months, HR 0.69, 95% CI 0.50-0.97). A trend toward improved OS was seen with nivolumab plus chemotherapy versus chemotherapy, regardless of the tumor mutation status of STK11 or TP53, regardless of tumor mutational burden, and in patients with intermediate/poor Lung Immune Prognostic Index scores. Safety with nivolumab plus chemotherapy was consistent with previous reports of first-line settings.

conclusionsCheckMate 227 Part 2 did not meet the primary endpoint of OS with nivolumab plus chemotherapy versus chemotherapy in patients with metastatic nonsquamous NSCLC. Descriptive analyses showed prolonged OS with nivolumab plus chemotherapy in all-randomized and squamous NSCLC populations, suggesting that this combination may benefit patients with untreated metastatic NSCLC.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Squamous CellLung NeoplasmsB7-H1 AntigenHumansNeoplasm Recurrence, LocalNivolumabB7-H1 AntigenNivolumabchemotherapyfirst lineimmunotherapynivolumabnonsquamous non-small-cell lung cancer

Identifiers

PMID37988950
PMCPMC10774956
OpenAlexW4388839606

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.