Evidence map›Paper›PMID 39369790›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2025

Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis.

Solange Peters, Luis G Paz-Ares, Martin Reck, David P Carbone, Julie R Brahmer, Hossein Borghaei, Shun Lu, Kenneth J O'Byrne, Thomas John, Tudor-Eliade Ciuleanu and 12 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02477826 phase3completednot on this map

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorBristol-Myers SquibbRan2015 to 2024Enrolled2,747ConditionsNon-Small Cell Lung CancerArmsNivolumab, Ipilimumab, Carboplatin, Cisplatin, Gemcitabine
NCT03215706 phase3completednot on this map

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2024Enrolled719ConditionsNon-Small Cell Lung CancerArmsIpilimumab, Nivolumab, Carboplatin, Paclitaxel, Pemetrexed
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Solange PetersOncology Department, Lausanne University Hospital, Lausanne, Switzerland. Electronic address: solange.peters@chuv.ch.
Luis G Paz-AresMedical Oncology Department, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.
Martin ReckDepartment of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungenClinic Grosshansdorf, Grosshansdorf, Germany.
David P CarboneDepartment of Medical Oncology, The Ohio State University Comprehensive Cancer Center and the Pelotonia Institute for Immuno-Oncology, Columbus, Ohio.
Julie R BrahmerDepartment of Oncology, The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins Medicine, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.
Hossein BorghaeiHematology and Oncology Department, Fox Chase Cancer Center, Temple Health, Philadelphia, Pennsylvania.
Shun LuDepartment of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Kenneth J O'ByrneDepartment of Medical Oncology, Princess Alexandra Hospital, Translational Research Institute and Queensland University of Technology, Brisbane, Queensland, Australia.
Thomas JohnMedical Oncology Department, Austin Hospital, Heidelberg, Victoria, Australia.
Tudor-Eliade CiuleanuDepartment of Medical Oncology, Institutul Oncologic Prof Dr Ion Chiricuţă and University of Medicine and Pharmacy Iuliu Haţieganu, Cluj-Napoca, Romania.
Michael SchenkerDepartment of Medical Oncology, SF Nectarie Oncology Center, Craiova, Romania.
Reyes Bernabe CaroMedical Oncology Department, Hospital Universitario Virgen Del Rocio, Instituto de Biomedicina de Seville, Seville, Spain.
Makoto NishioDepartment of Thoracic Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Manuel CoboDepartment of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.
Jong-Seok LeeDepartment of Hematology/Oncology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Bogdan ZurawskiChemotherapy Department, Ambulatorium Chemioterapii, Bydgoszcz, Poland.
Adam PluzanskiDepartment of Lung Cancer and Chest Tumours, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Takekazu AoyamaClinical Development, Bristol Myers Squibb, Princeton, New Jersey.
Marina TschaikaGlobal Clinical Research Oncology, Bristol Myers Squibb, Princeton, New Jersey.
Vipul DevasGlobal Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, New Jersey.
Diederik J GrootendorstTranslational Sciences Oncology Imaging, Bristol Myers Squibb, Princeton, New Jersey.
Suresh S RamalingamDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNivolumab plus ipilimumab-based treatment regimens have shown long-term, durable efficacy benefits in patients with metastatic NSCLC. Here we report clinical outcomes from a pooled analysis of patients with metastatic NSCLC and tumor programmed death-ligand 1 (PD-L1) lower than 1% treated with first-line nivolumab plus ipilimumab with or without two cycles of chemotherapy versus up to four cycles of chemotherapy in the randomized phase 3 CheckMate 227 and CheckMate 9LA studies.

methodsPatients were aged 18 years or older and had stage IV or recurrent NSCLC with no sensitizing EGFR/ALK alterations. Assessments included overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety.

resultsIn patients with tumor PD-L1 lower than 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 322) versus chemotherapy (n = 315) arms, median OS was 17.4 versus 11.3 months, respectively, (hazard ratio [HR] = 0.64, 95% confidence interval [CI]: 0.54-0.76; 5-y OS rate, 20% versus 7%) at a median follow-up of 73.7 months. The OS benefit was observed across key subgroups, including difficult-to-treat populations such as those with baseline brain metastases (HR = 0.44, 95% CI: 0.26-0.75) or squamous NSCLC (HR = 0.51, 95% CI: 0.36-0.72). In the overall pooled population, the median PFS was 5.4 versus 4.9 months (HR = 0.72, 95% CI: 0.60-0.87; 5-y PFS rate, 9% versus 2%), the objective response rate was 29% versus 22%, and the median duration of response was 18.0 versus 4.6 months. No new safety signals were observed.

conclusionNivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 lower than 1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need. CLINICAL TRIAL REGISTRATIONS: NCT02477826, NCT03215706.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarcinoma, Non-Small-Cell LungIpilimumabLung NeoplasmsNivolumabAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedSurvival RateB7-H1 AntigenCD274 protein, humanIpilimumabNivolumabImmunotherapyIpilimumabNivolumabNon–small cell lung cancerPD-L1

Identifiers

PMID39369790

What Socratic holds

Textmetadata
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Registered trials

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 Socratic graph.