Evidence map›Paper›PMID 32468956›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study.

Charles M Rudin, Mark M Awad, Alejandro Navarro, Maya Gottfried, Solange Peters, Tibor Csőszi, Parneet K Cheema, Delvys Rodriguez-Abreu, Mirjana Wollner, James Chih-Hsin Yang and 11 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. 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 489 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
489citing papers in PubMed, 10 pooled it
37.0field-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.

NCT03066778 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2021Enrolled453ConditionsSmall Cell Lung Cancer (SCLC)ArmsPembrolizumab, Normal saline solution, Carboplatin, Cisplatin, Etoposide
NCT07083375 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Bevacizumab and Platinum-based Chemotherapy in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

TypeinterventionalSponsorZhijie WangRan2025 to 2027Enrolled56ConditionsExtensive Small Cell Lung CancerArmsQL1706 , bevacizumab, etoposide , cisplatin or carboplatin
3 · Its place in the literature

Who cites it

489 citing papers in PubMed, 10 syntheses or guidelines pooled it, 740 citations in OpenAlex.

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

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

21 authors at 16 institutions in 11 countries.

Charles M RudinMemorial Sloan Kettering Cancer Center, New York, NY.
Mark M AwadDana-Farber Cancer Institute, Boston, MA.
Alejandro NavarroVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Maya GottfriedMeir Medical Center, Kfar-Saba, Israel.
Solange PetersLausanne University Hospital, Lausanne, Switzerland.
Tibor CsősziHetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary.
Parneet K CheemaWilliam Osler Health System, University of Toronto, Brampton, Ontario, Canada.
Delvys Rodriguez-AbreuComplejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.
Mirjana WollnerRambam Medical Center, Haifa, Israel.
James Chih-Hsin YangNational Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.
Julien MazieresCentre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.
Francisco J OrlandiOncología-Health and Care, Santiago, Chile.
Alexander LuftLeningrad Regional Clinical Hospital, St Petersburg, Russia.
Mahmut GümüşIstanbul Medeniyet University Hospital, Istanbul, Turkey.
Terufumi KatoKanagawa Cancer Center, Yokohama, Japan.
Gregory P KalemkerianUniversity of Michigan, Ann Arbor, MI.
Yiwen LuoMerck & Co, Kenilworth, NJ.
Victoria EbianaMerck & Co, Kenilworth, NJ.
M Catherine PietanzaMerck & Co, Kenilworth, NJ.
Hye Ryun KimYonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
KEYNOTE-604 Investigators
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDana-Farber Cancer Institute · USIstanbul Medeniyet University · TRKanagawa Prefectural Hospital Organization · JPLeningrad Regional Cancer Center · RUMeir Medical Center · ILMemorial Sloan Kettering Cancer Center · USNational Taiwan University Hospital · TWRambam Health Care Campus · ILUniversidad de Las Palmas de Gran Canaria · ESUniversité Toulouse III - Paul Sabatier · FRUniversity of Lausanne · CHUniversity of Michigan · USVall d'Hebron Hospital Universitari · ESWilliam Osler Health System · CAYonsei University · KR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposePembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC.

methodsEligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided

resultsOf the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;

conclusionPembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodEtoposideFemaleHumansLung NeoplasmsMaleNeoplasm StagingPlatinumSmall Cell Lung CarcinomaSurvival AnalysisAntibodies, Monoclonal, HumanizedEtoposidepembrolizumabPlatinum

Identifiers

PMID32468956
PMCPMC7474472
OpenAlexW3030178583

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.