Evidence map›Paper›PMID 38346853›Full record

Trial reportJournal for immunotherapy of cancer2024

Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.

David P Carbone, Tudor-Eliade Ciuleanu, Michael Schenker, Manuel Cobo, Stéphanie Bordenave, Oscar Juan-Vidal, Juliana Menezes, Niels Reinmuth, Eduardo Richardet, Ying Cheng and 16 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
16.1field-weighted citation impact, top 1% 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

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  6. 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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  12. Enhanced antitumor efficacy of combined targeting of adenosine ACancer immunology, immunotherapy : CII · 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

26 authors at 19 institutions in 10 countries.

David P CarboneDivision of Medical Oncology and the Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA david.carbone@osumc.edu.ORCID 0000-0003-3002-1921
Tudor-Eliade CiuleanuDepartment of Medical Oncology, Institutul Oncologic Prof Dr Ion Chiricută and University of Medicine and Pharmacy Iuliu Haţieganu, Cluj-Napoca, Romania.
Michael SchenkerDepartment of Medical Oncology, SF Nectarie Oncology Center, Craiova, Romania.
Manuel CoboDepartment of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
Stéphanie BordenaveL'institut du Thorax, Nantes, France.
Oscar Juan-VidalDepartment of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain.
Juliana MenezesDepartment of Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.
Niels ReinmuthDepartment of Oncology, Asklepios Lung Clinic, German Center for Lung Research, Munich-Gauting, Germany.
Eduardo RichardetDepartment of Clinical Oncology, IONC Instituto Oncológico de Córdoba, Córdoba, Argentina.
Ying ChengDepartment of Oncology, Jilin Cancer Hospital, Changchun, Jilin, China.
Hideaki MizutaniDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
Enriqueta FelipMedical Oncology Service, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Bogdan ZurawskiChemotherapy Department, Ambulatorium Chemioterapii, Bydgoszcz, Poland.
Aurelia AlexandruDepartment of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania.
Luis Paz-AresMedical Oncology Department, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.
Shun LuDepartment of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.
Thomas JohnMedical Oncology Department, Austin Hospital, Heidelberg, Victoria, Australia.
Xiaoqing ZhangGlobal Drug Development, Oncology Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Javed MahmoodGlobal Drug Development, Oncology Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Nan HuGlobal Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, New Jersey, USA.
Tuli DeParexel, Billerica, Massachusetts, USA.
Irene SantiParexel, Billerica, Massachusetts, USA.
John R PenrodGlobal Drug Development, Oncology Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Yong YuanGlobal Drug Development, Oncology Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Adam LeeGlobal Drug Development, Oncology Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Martin ReckDepartment of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, Lung Clinic, Grosshansdorf, Germany.
Bristol-Myers Squibb (United States) · USPAREXEL International (United States) · USAsklepios Fachkliniken München-Gauting · DEAustin Hospital · AUGerman Center for Lung Research · DEHospital Nossa Senhora da Conceição · BRHospital Universitari i Politècnic La Fe · ESInstitut du Thorax · FRInstitute of Oncology Prof. Dr. Ion Chiricuta · ROInstituto de Investigación Biomédica de Málaga · ESInstituto Oncológico de Córdoba · ARInstitutul Oncologic Bucuresti · ROJilin Province Tumor Hospital · CNSaitama Cancer Center · JPShanghai Jiao Tong University · CNThe Ohio State University · USUniversidad Complutense de Madrid · ESUniversity of Medicine and Pharmacy of Craiova · ROVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn CheckMate 9LA, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy regardless of tumor PD-L1 expression or histology. We report updated efficacy and safety in all randomized patients with a minimum 4-year follow-up and an exploratory treatment-switching adjustment analysis in all treated patients who received chemotherapy and subsequent immunotherapy.

methodsAdults with stage IV/recurrent non-small cell lung cancer (NSCLC), no sensitizing

resultsWith a 47.9-month minimum follow-up for OS, nivolumab plus ipilimumab with chemotherapy continued to prolong OS over chemotherapy in all randomized patients (HR 0.74, 95% CI 0.63 to 0.87; 4-year OS rate: 21% versus 16%), regardless of tumor PD-L1 expression (HR (95% CI): PD-L1<1%, 0.66 (0.50 to 0.86) and ≥1%, 0.74 (0.60 to 0.92)) or histology (squamous, 0.64 (0.48 to 0.84) and non-squamous, 0.80 (0.66 to 0.97)). In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy due to TRAEs (n=61), the 4-year OS rate was 41%. With treatment-switching adjustment for the 36% of patients receiving subsequent immunotherapy in the chemotherapy arm, the estimated HR of nivolumab plus ipilimumab with chemotherapy versus chemotherapy was 0.66 (95% CI 0.55 to 0.80). No new safety signals were observed.

conclusionsIn this 4-year update, patients treated with nivolumab plus ipilimumab with chemotherapy continued to have long-term, durable efficacy benefit over chemotherapy regardless of tumor PD-L1 expression and/or histology. A greater estimated relative OS benefit was observed after adjustment for subsequent immunotherapy use in the chemotherapy arm. These results further support nivolumab plus ipilimumab with chemotherapy as a first-line treatment for patients with metastatic/recurrent NSCLC, including those with tumor PD-L1<1% or squamous histology, populations with high unmet needs.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Squamous CellLung NeoplasmsAdultB7-H1 AntigenHumansIpilimumabNeoplasm Recurrence, LocalNivolumabTreatment SwitchingB7-H1 AntigenIpilimumabNivolumabclinical trials, phase III as topicdrug therapy, combinationimmunotherapynon-small cell lung cancerprogrammed cell death 1 receptor

Identifiers

PMID38346853
PMCPMC10862253
OpenAlexW4391743853

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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.