https://m2.mtmt.hu/ hun 2026-09-23 02:34 JournalArticle 34427343 VALIDATED true The Christie Hospital, Manchester, United Kingdom University of Colorado Cancer Center, Aurora, CO, United States Leningrad Regional Clinical Hospital, St Petersburg, Russian Federation Regional Lung Disease Hospital, Otwock, Poland Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania Institute of Oncology, Bucharest, Romania Poznan University of Medical Sciences, Poznań, Poland Omsk Regional Oncology Center, Omsk, Russian Federation Csongrád County Hospital of Chest Diseases, Deszk, Hungary Semmelweis University Department of Pulmonology, Budapest, Hungary Tuberculosis and Lung Disease Hospital, Olsztyn, Poland Samsung Medical Center, Seoul, South Korea Department of Internal Medicine II, University Hospital of Ulm, Ulm, Germany Clinic for Pneumology, Thoracic Oncology, Sleep- and Respiratory Critical Care, Kempten-Oberallgaeu Hospitals, Kempten, Germany Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany Lilly Deutschland GmbH, Bad Homburg, Germany Eli Lilly and Company, Bridgewater, NJ, United States Instituto de Biomedicina de Sevilla - IBIS (Hospital Virgen del Rocío, Universidad de Sevilla and CSIC), Seville, Spain Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States Cited By :414 Export Date: 23 September 2024 CODEN: LOANB Correspondence Address: Thatcher, N.; The Christie Hospital NHS Trust, Wilmslow Road, United Kingdom; email: nick.thatcher@christie.nhs.uk Chemicals/CAS: cisplatin, 15663-27-1, 26035-31-4, 96081-74-2; gemcitabine, 103882-84-4; necitumumab, 906805-06-9; gentamicin, 1392-48-9, 1403-66-3, 1405-41-0; Antibodies, Monoclonal; Cisplatin; Gentamicins; IMC-11F8 monoclonal antibody Funding details: PI1102688 Funding details: R12/0036/0028 Funding details: Eli Lilly and Company Funding text 1: This study was funded by Eli Lilly and Company. We thank the patients, their families and the study personnel across all sites for participating in this study. LP-A is funded by Fondo de Investigación Sanitaria (PI1102688) and Red Temática de Investigación Cooperativa en Cáncer (R12/0036/0028). Writing and editorial assistance were funded by Eli Lilly and Company: Jim Heighway of Cancer Communications and Consultancy Ltd (Knutsford, UK) and Ryan Widau of Eli Lilly and Company (Indianapolis, IN, USA) provided writing assistance. Anastasia Perkowski of Eli Lilly and Company (Bridgewater, NJ, USA) provided editorial assistance. 0 false 2026-08-14T10:20:17.716+0000 2023-12-09T19:49:11.066+0000 2023-12-09T19:43:27.260+0000 true 10085578 Fi Tamás /api/admin/10085578 Admin true 2024-09-23T09:51:44.881+0000 2023-12-09T19:49:11.384+0000 true 10085578 Fi Tamás /api/admin/10085578 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Thatcher, Nick Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE) an open-label, randomised, controlled phase 3 trial. true true /api/journal/10001287 REVIEWED true false 10001287 false 10001287 true 1470-2045 1474-5488 Journal FOREIGN 16 7 763 774 763 12 2015 Necitumumab is a second-generation, recombinant, human immunoglobulin G1 EGFR antibody. In this study, we aimed to compare treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous non-small-cell lung cancer.We did this open-label, randomised phase 3 study at 184 investigative sites in 26 countries. Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous non-small-cell lung cancer, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion. Enrolled patients were randomly assigned centrally 1:1 to a maximum of six 3-week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomisation scheme (block size of four) by a telephone-based interactive voice response system or interactive web response system. Chemotherapy was gemcitabine 1250 mg/m(2) administered intravenously over 30 min on days 1 and 8 of a 3-week cycle and cisplatin 75 mg/m(2) administered intravenously over 120 min on day 1 of a 3-week cycle. Necitumumab 800 mg, administered intravenously over a minimum of 50 min on days 1 and 8, was continued after the end of chemotherapy until disease progression or intolerable toxic side-effects occurred. Randomisation was stratified by ECOG performance status and geographical region. Neither physicians nor patients were masked to group assignment because of the expected occurrence of acne-like rash--a class effect of EGFR antibodies--that would have unmasked most patients and investigators to treatment. The primary endpoint was overall survival, analysed by intention to treat. We report the final clinical analysis. This study is registered with ClinicalTrials.gov, number NCT00981058.Between Jan 7, 2010, and Feb 22, 2012, we enrolled 1093 patients and randomly assigned them to receive necitumumab plus gemcitabine and cisplatin (n=545) or gemcitabine and cisplatin (n=548). Overall survival was significantly longer in the necitumumab plus gemcitabine and cisplatin group than in the gemcitabine and cisplatin alone group (median 11·5 months [95% CI 10·4-12·6]) vs 9·9 months [8·9-11·1]; stratified hazard ratio 0·84 [95% CI 0·74-0·96; p=0·01]). In the necitumumab plus gemcitabine and cisplatin group, the number of patients with at least one grade 3 or worse adverse event was higher (388 [72%] of 538 patients) than in the gemcitabine and cisplatin group (333 [62%] of 541), as was the incidence of serious adverse events (257 [48%] of 538 patients vs 203 [38%] of 541). More patients in the necitumumab plus gemcitabine and cisplatin group had grade 3-4 hypomagnesaemia (47 [9%] of 538 patients in the necitumumab plus gemcitabine and cisplatin group vs six [1%] of 541 in the gemcitabine and cisplatin group) and grade 3 rash (20 [4%] vs one [<1%]). Including events related to disease progression, adverse events with an outcome of death were reported for 66 (12%) of 538 patients in the necitumumab plus gemcitabine and cisplatin group and 57 (11%) of 541 patients in the gemcitabine and cisplatin group; these were deemed to be related to study drugs in 15 (3%) and ten (2%) patients, respectively. Overall, we found that the safety profile of necitumumab plus gemcitabine and cisplatin was acceptable and in line with expectations.Our findings show that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improves overall survival in patients with advanced squamous non-small-cell lung cancer and represents a new first-line treatment option for this disease.Eli Lilly and Company. true 2023 true true true false true false NONE 2026-08-14 false 457 0 457 378 4 456 434 403 419 457 457 378 378 378 79 0 457 378 457 378 0 2 2 Folyóiratcikk Journal Article 24 435 Könyvrészlet Chapter in Book 25 20 Könyv Book 23 2 Egyéb konferenciaközlemény Conference paper 31 0 Egyéb konferenciakötet Conference proceedings 32 0 Oltalmi formák Protection forms 26 0 Disszertáció Thesis 28 0 Egyéb Miscellaneous 29 0 Alkotás Achievement 22 0 Kutatási adat Research data 33 0 Folyóiratcikk Journal Article 24 0 0 0 Könyvrészlet Chapter in Book 25 0 0 0 Könyv Book 23 0 0 0 Egyéb 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/api/publicationidentifier/25091938 PlainSource 17 /api/publicationsource/17 PublicationSourceType 10003 /api/publicationsourcetype/10003 false true true PubMed PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=@@@&dopt=Abstract true true 17 true IDENTICAL 26045340 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=26045340&dopt=Abstract false true Classification 12215 /api/classification/12215 true true SjrRating 11043876 /api/sjrrating/11043876 3 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2730 /api/classificationexternal/2730 true 2730 true D1 DIRECT true true /api/publication/34427343 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Thatcher Nick ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hirsch Fred R </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Luft Alexander V </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Szczesna Aleksandra </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ciuleanu Tudor E </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dediu Mircea </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ramlau Rodryg </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Galiulin Rinat K </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10028888"><a href="/gui2/?type=authors&mode=browse&sel=10028888" target="_blank">Bálint Beatrix (<span class="authorship-author-name">Bálint Beatrix</span> <span class="authorAux-mtmt"> pulmonológia, kardiológia, rehabilitáció</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10004124"><a href="/gui2/?type=authors&mode=browse&sel=10004124" target="_blank">Losonczy György (<span class="authorship-author-name">Losonczy György</span> <span class="authorAux-mtmt"> Pulmonológia, klinikai onkológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Pulmonológiai Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kazarnowicz Andrzej </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Park Keunchil </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Schumann Christian </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Reck Martin </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Depenbrock Henrik </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Nanda Shivani </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kruljac-Letunic Anamarija </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kurek Raffael </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Paz-Ares Luis </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Socinski Mark A </span> </div> <div class="autype autype-11"> Kollaborációs közreműködő: <span class="author-name" >Briggs Peter </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10028888"><a href="/gui2/?type=authors&mode=browse&sel=10028888" target="_blank">Bálint Beatrix (<span class="authorship-author-name">Bálint Beatrix</span> <span class="authorAux-mtmt"> pulmonológia, kardiológia, rehabilitáció</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10004124"><a href="/gui2/?type=authors&mode=browse&sel=10004124" target="_blank">Losonczy György (<span class="authorship-author-name">Losonczy György</span> <span class="authorAux-mtmt"> Pulmonológia, klinikai onkológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Pulmonológiai Klinika</span> ;&nbsp;&nbsp;&nbsp; et al. (203) </div> <div class="autype autype-29"> Kollaborációs szervezet: <span class="author-affil">SQUIRE Investigators</span> </div> <div><a target="_blank" href="/api/publication/34427343?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;34427343" target="_blank">Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE) : an open-label, randomised, controlled phase 3 trial..</a></div> <div> <span class="journal-title">LANCET ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1470-2045">1470-2045</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-5488">1474-5488</a>)</span>: <span class="journal-volume">16</span> <span class="journal-issue">7</span> <span class="page"> pp 763-774 </span> <span class="year">(2015)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/S1470-2045(15)00021-2" target="_blank" href="https://doi.org/10.1016/S1470-2045%2815%2900021-2"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000357273600050" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000357273600050"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="84937518476" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-84937518476"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="26045340" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=26045340&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 457</span> | Független: 378 | Függő: 79 | Nem jelölt: 0 | WoS jelölt: 403 | Scopus jelölt:&nbsp;419 | WoS/Scopus jelölt:&nbsp;457 | DOI jelölt:&nbsp;434 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;34427343&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 2 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 34427343</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">PubMed XML</span> </div> <div class="lastModified">Utolsó módosítás: 2023.12.09. 20:49 Fi Tamás (SE_AOK_Pulmonologia_Admin5_FT, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: The Christie Hospital, Manchester, United Kingdom University of Colorado Cancer Center, Aurora, CO, United States Leningrad Regional Clinical Hospital, St Petersburg, Russian Federation Regional Lung Disease Hospital, Otwock, Poland Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, ...</pre> </div></div>