Evidence map›Paper›PMID 36008722›Full record

Trial reportNature medicine2022

Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.

Miranda Gogishvili, Tamar Melkadze, Tamta Makharadze, Davit Giorgadze, Mikhail Dvorkin, Konstantin Penkov, Konstantin Laktionov, Gia Nemsadze, Marina Nechaeva, Irina Rozhkova and 16 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature medicine, 2022. 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 188 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 22 pooled it
27.3field-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.

NCT03409614 phase3completednot on this map

A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2018 to 2025Enrolled789ConditionsNon-small Cell Lung CancerArmsREGN2810, REGN2810/chemo/ipi, Chemotherapy, Placebo
NCT06865339 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorMontefiore Medical CenterRan2025 to 2027Enrolled76ConditionsNSCLC, Locally AdvancedArmsCemiplimab, Fianlimab, Radiotherapy, Platinum Doublet Chemotherapy (PDC)
3 · Its place in the literature

Who cites it

188 citing papers in PubMed, 22 syntheses or guidelines pooled it, 279 citations in OpenAlex.

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  2. Use of PD-1/PD-L1 inhibitors in non-small cell lung cancer in elderly patients: a meta-analysis and systematic review of randomized clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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128 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

26 authors at 10 institutions in 7 countries.

Miranda GogishviliHigh Technology Medical Centre, University Clinic Ltd., Tbilisi, Georgia. mirandagogishvili@yahoo.com.ORCID http://orcid.org/0000-0002-5143-6379
Tamar MelkadzeAcad. F. Todua Medical Center, Tbilisi, Georgia.
Tamta MakharadzeLTD High Technology Hospital Med Center, Batumi, Georgia.
Davit GiorgadzeDavid Tvildiani Medical University, Tbilisi, Georgia.
Mikhail DvorkinState Budgetary Healthcare Institution of Omsk Region, Omsk, Russia.
Konstantin PenkovPrivate Medical Institution Euromedservice, Saint Petersburg, Russia.
Konstantin LaktionovFederal State Budgetary Institution 'N.N. Blokhin National Medical Research Center of Oncology' of the Ministry of Health of the Russian Federation, Moscow, Russia.
Gia NemsadzeThe Institute of Clinical Oncology, Tbilisi, Georgia.
Marina NechaevaChelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Chelyabinsk, Russia.
Irina RozhkovaKaluga Regional Clinical Oncology Dispensary, Kaluga, Russia.
Ewa KalinkaPolish Mother's Memorial Hospital Research Institute, Łódź, Poland.ORCID http://orcid.org/0000-0003-4791-8372
Christian GessnerPOIS Leipzig GbR, Leipzig, Germany.
Brizio Moreno-JaimeHospital Regional ISSSTE, León, Mexico.
Rodolfo PassalacquaIstituti Ospitalieri Di Cremona, Cremona, Italy.
Siyu LiRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Kristina McGuireRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Manika KaulRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Anne PaccalyRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Ruben G W QuekRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID http://orcid.org/0000-0001-9602-3239
Bo GaoRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Frank SeebachRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
David M WeinreichRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
George D YancopoulosRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Israel LowyRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Giuseppe GulloRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Petra RietschelRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Regeneron (United States) · USBudgetary Healthcare Institution of Omsk Region Regional Clinical Hospital · RUChelyabinsk Regional Clinical Oncology Center · RUDavid Tvildiani Medical University · GEInstitute for Social Security and Services for State Workers · MXIstituti Ospitalieri di Cremona · ITLeipzig University · DEMinistry of Health of the Russian Federation · RUPolish Mother’s Memorial Hospital Research Institute · PLTbilisi State Medical University · GE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

First-line cemiplimab (anti-programmed cell death-1 (PD-1)) monotherapy has previously shown significant improvement in overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with advanced non-small cell lung cancer (aNSCLC) and PD-ligand 1 (PD-L1) expression ≥50%. EMPOWER-Lung 3 ( NCT03409614 ), a double-blind, placebo-controlled, phase 3 study, examined cemiplimab plus platinum-doublet chemotherapy as first-line treatment for aNSCLC, irrespective of PD-L1 expression or histology. In this study, 466 patients with stage III/IV aNSCLC without EGFR, ALK or ROS1 genomic tumor aberrations were randomized (2:1) to receive cemiplimab 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks in combination with four cycles of platinum-doublet chemotherapy (followed by pemetrexed maintenance as indicated). In total, 57.1% (266/466 patients) had non-squamous NSCLC, and 85.2% (397/466 patients) had stage IV disease. The primary endpoint was OS. The trial was stopped early per recommendation of the independent data monitoring committee, based on meeting preset OS efficacy criteria: median OS was 21.9 months (95% confidence interval (CI), 15.5-not evaluable) with cemiplimab plus chemotherapy versus 13.0 months (95% CI, 11.9-16.1) with placebo plus chemotherapy (hazard ratio (HR) = 0.71; 95% CI, 0.53-0.93; P = 0.014). Grade ≥3 adverse events occurred with cemiplimab plus chemotherapy (43.6%, 136/312 patients) and placebo plus chemotherapy (31.4%, 48/153 patients). Cemiplimab is only the second anti-PD-1/PD-L1 agent to show efficacy in aNSCLC as both monotherapy and in combination with chemotherapy for both squamous and non-squamous histologies.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenDisease-Free SurvivalDouble-Blind MethodHumansPlatinumProtein-Tyrosine KinasesProto-Oncogene ProteinsAntibodies, Monoclonal, HumanizedB7-H1 AntigencemiplimabPlatinumProtein-Tyrosine KinasesProto-Oncogene Proteins

Identifiers

PMID36008722
PMCPMC9671806
OpenAlexW4293237625

What OpenQuestion holds

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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.