Evidence map›Paper›PMID 36764316›Full record

Trial reportLancet (London, England)2023

Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRAS

Adrianus Johannes de Langen, Melissa L Johnson, Julien Mazieres, Anne-Marie C Dingemans, Giannis Mountzios, Miklos Pless, Jürgen Wolf, Martin Schuler, Hervé Lena, Ferdinandos Skoulidis and 23 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 369 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
369citing papers in PubMed, 5 pooled it
134.9field-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

369 citing papers in PubMed, 5 syntheses or guidelines pooled it, 523 citations in OpenAlex.

  1. Pooled it
  2. Targeting KRASFrontiers in oncology · 2026
    Pooled it
  3. KRASFrontiers in oncology · 2026
    Pooled it
  4. KRAS G12C inhibitors in KRASFrontiers in immunology · 2026
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Glecirasib in KRASNature medicine · 2025
    Trial
  9. Phase I/II Trial of Exportin 1 Inhibitor Selinexor plus Docetaxel in Previously Treated, Advanced KRAS-Mutant Non-Small Cell Lung Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  10. Next-generation sequencing using a targeted gene panel in advanced solid tumors: five years of experience from an Italian referral institution.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  11. Review
  12. Review
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  14. Review
  15. Article
  16. Review
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  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 20 institutions in 14 countries.

Adrianus Johannes de LangenNetherlands Cancer Institute, Amsterdam, Netherlands.
Melissa L JohnsonSarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, USA.
Julien MazieresCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Anne-Marie C DingemansErasmus MC Cancer Institute, University Medical Center, Rotterdam, Netherlands.
Giannis MountziosHenry Dunant Hospital Center, Athens, Greece.
Miklos PlessDepartment of Medical Oncology, Cancer Center Kantonsspital Winterthur, Winterthur, Switzerland.
Jürgen WolfCenter for Integrated Oncology, University Hospital Cologne, Cologne, Germany.
Martin SchulerWest German Cancer Center, University Hospital Essen, Essen, Germany.
Hervé LenaCentre Hospitalier Universitaire de Rennes-Hopital Pontchaillou, Rennes, France.
Ferdinandos SkoulidisUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yasuto YoneshimaKyushu University Hospital, Fukuoka, Japan.
Sang-We KimAsan Medical Center, Seoul, South Korea.
Helena LinardouMetropolitan Hospital, Athens, Greece.
Silvia NovelloDepartment of Oncology, Università Degli Studi Di Torino-San Luigi Hospital Orbassano, Italy.
Anthonie J van der WekkenDepartment of Pulmonology and Tuberculosis, University of Groningen, Medical Centre Groningen, Groningen, Netherlands.
Yuanbin ChenCancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.
Solange PetersOncology Department-CHUV, Lausanne University, Lausanne, Switzerland.
Enriqueta FelipMedical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.
Benjamin J SolomonPeter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Suresh S RamalingamWinship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.
Christophe DoomsDepartment of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium.
Colin R LindsayDivision of Cancer Sciences, University of Manchester, Manchester, UK; The Christie NHS Foundation Trust, Manchester, UK.
Carlos Gil FerreiraOncoclinicas, Rio De Janeiro, Brazil.
Normand BlaisDepartment of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Cynthia C ObiozorAmgen, Thousand Oaks, CA, USA.
Yang WangAmgen, Thousand Oaks, CA, USA.
Bhakti MehtaAmgen, Thousand Oaks, CA, USA.
Tracy VarrieurAmgen, Thousand Oaks, CA, USA.
Gataree NgarmchamnanrithAmgen, Thousand Oaks, CA, USA.
Björn StollenwerkAmgen (Europe), Rotkreuz, Switzerland.
David WaterhouseOncology Hematology Care, Cincinnati, OH, USA.
Luis Paz-AresHospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Complutense University and Ciberonc, Madrid, Spain. Electronic address: lpazaresr@seom.org.
CodeBreaK 200 Investigators
Amgen (United States) · USAmgen (Switzerland) · CHAsan Medical Center · KRCentre Hospitalier de l’Université de Montréal · CACentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Toulouse · FRDutch Cancer Society · NLEmory University · USErasmus MC Cancer Institute · NLHematology Oncology Consultants · USHenry Dunant Hospital · GRHospital Universitario 12 De Octubre · ESKantonsspital Winterthur · CHKU Leuven · BEKyushu University Hospital · JPMetropolitan Hospital · GROncology Hematology Care · USPeter MacCallum Cancer Centre · AUTennessee Oncology · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSotorasib is a specific, irreversible inhibitor of the GTPase protein, KRAS

methodsWe conducted a randomised, open-label phase 3 trial at 148 centres in 22 countries. We recruited patients aged at least 18 years with KRAS

findingsBetween June 4, 2020, and April 26, 2021, 345 patients were randomly assigned to receive sotorasib (n=171 [50%]) or docetaxel (n=174 [50%]). 169 (99%) patients in the sotorasib group and 151 (87%) in the docetaxel group received at least one dose. After a median follow-up of 17·7 months (IQR 16·4-20·1), the study met its primary endpoint of a statistically significant increase in the progression-free survival for sotorasib, compared with docetaxel (median progression-free survival 5·6 months [95% CI 4·3-7·8] vs 4·5 months [3·0-5·7]; hazard ratio 0·66 [0·51-0·86]; p=0·0017). Sotorasib was well tolerated, with fewer grade 3 or worse (n=56 [33%] vs n=61 [40%]) and serious treatment-related adverse events compared with docetaxel (n=18 [11%] vs n=34 [23%]). For sotorasib, the most common treatment-related adverse events of grade 3 or worse were diarrhoea (n= 20 [12%]), alanine aminotransferase increase (n=13 [8%]), and aspartate aminotransferase increase (n=9 [5%]). For docetaxel, the most common treatment-related adverse events of grade 3 or worse were neutropenia (n=13 [9%]), fatigue (n=9 [6%]), and febrile neutropenia (n=8 [5%]).

interpretationSotorasib significantly increased progression-free survival and had a more favourable safety profile, compared with docetaxel, in patients with advanced NSCLC with the KRAS

fundingAmgen.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDocetaxelHumansMutationPiperazinesProto-Oncogene Proteins p21(ras)PyridinesPyrimidinesAntineoplastic AgentsDocetaxelKRAS protein, humanPiperazinesProto-Oncogene Proteins p21(ras)PyridinesPyrimidinessotorasib

Identifiers

PMID36764316
OpenAlexW4319337483

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.