Evidence map›Paper›PMID 30316010›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2019

Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.

Neal Ready, Anna F Farago, Filippo de Braud, Akin Atmaca, Matthew D Hellmann, Jeffrey G Schneider, David R Spigel, Victor Moreno, Ian Chau, Christine L Hann and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04421352 (A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors), which is not on this map. Cited by 184 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
184citing papers in PubMed, 13 pooled it
18.7field-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.

NCT04421352 phase1completednot on this mapstarted 2021, after this paper: background citation

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

TypeinterventionalSponsorCStone PharmaceuticalsRan2021 to 2023Enrolled11ConditionsRelapsed Small Cell Lung CancerArmsCS1001
3 · Its place in the literature

Who cites it

184 citing papers in PubMed, 13 syntheses or guidelines pooled it, 374 citations in OpenAlex.

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  7. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnnals of oncology : official journal of the European Society for Medical Oncology · 2021
    Guideline
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  19. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  20. Trial

124 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 14 institutions in 5 countries.

Neal ReadyDuke University Medical Center, Durham, North Carolina. Electronic address: neal.ready@duke.edu.
Anna F FaragoMassachusetts General Hospital, Boston, Massachusetts.
Filippo de BraudFondazione IRCCS Istituto Nazionale dei Tumori Milano and University of Milan, Milan, Italy.
Akin AtmacaKrankenhaus Nordwest-Institut für Klinisch-Onkologische Forschung, UCT-University Cancer Center, Frankfurt am Main, Germany.
Matthew D HellmannMemorial Sloan Kettering Cancer Center Hospital, New York, New York.
Jeffrey G SchneiderNew York Uuniversity Winthrop University Hospital, Mineola, New York.
David R SpigelSarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
Victor MorenoSTART Madrid-FJD. Hospital Fundación Jiménez Díaz, Madrid, Spain.
Ian ChauRoyal Marsden National Health Service Foundation Trust, Surrey, United Kingdom.
Christine L HannSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.
Joseph Paul EderYale Cancer Center, New Haven, Connecticut.
Nicola L SteeleBeatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
Anne PietersBristol-Myers Squibb, Princeton, New Jersey.
Justin FairchildBristol-Myers Squibb, Princeton, New Jersey.
Scott J AntoniaH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
Bristol-Myers Squibb (United States) · USBeatson West of Scotland Cancer Centre · GBDuke Medical Center · USHospital Universitario Fundación Jiménez Díaz · ESKrankenhaus Nordwest · DEMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USRoyal Marsden NHS Foundation Trust · GBSarah Cannon · USSidney Kimmel Comprehensive Cancer Center · USUniversity of Milan · ITWinthrop-University Hospital · USYale Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

introductionFor patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC.

methodsIn this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety.

resultsBetween December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5-19.5) with a median duration of response of 17.9 months (range 3.0-42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events.

conclusionsNivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.

Indexed as

AgedAged, 80 and overAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenDisease ProgressionFemaleHumansLung NeoplasmsMaleMiddle AgedNivolumabProgression-Free SurvivalRetreatmentSmall Cell Lung CarcinomaSurvival RateAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanNivolumabImmunotherapyNivolumabPD-1 inhibitorSCLCThird-line

Identifiers

PMID30316010
PMCPMC8050700
OpenAlexW2897191292

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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 OpenQuestion graph.