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DAREON ® -Lung-1: En undersøgelse hos personer med fremskreden småcellet lungekræft for at sammenligne behandling med Obrixtamig plus Atezolizumab, Carboplatin og Etoposid med standard kemoterapi

9. november 2026 opdateret af: Boehringer Ingelheim

DAREON ® -Lung-1: En fase III multicentrisk, åben, randomiseret undersøgelse af intravenøs Obrixtamig i kombination med Atezolizumab, Carboplatin og Etoposide kontra Atezolizumab, Carboplatin og Etoposide som førstelinjebehandling hos patienter med ekstensivt stadium af småcellet lungekræft

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.

Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.

Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

670

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Argentina
      • CABA, Argentina, 1430
      • CABA, Argentina, 1280AEB
        • Rekruttering
        • Hospital Britanico de Buenos Aires
        • Kontakt:
      • Munro, Argentina, B1605
      • Nueva Córdoba, Argentina, X5000JHQ
      • Rosario, Argentina, S2000DSV
  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Rekruttering
        • Prince of Wales Hospital-Randwick-66496
        • Kontakt:
    • South Australia
      • Adelaide, South Australia, Australien, 5000
    • Victoria
      • Ballarat, Victoria, Australien, 3350
        • Rekruttering
        • Ballarat Regional Integrated Cancer Centre
        • Kontakt:
  • Belgien
      • Brussels, Belgien, 1160
        • Ikke rekrutterer endnu
        • Centre Hospitalier Interrégional Edith Cavell (CHIREC)
        • Kontakt:
      • Edegem, Belgien, 2650
        • Ikke rekrutterer endnu
        • Universitair Ziekenhuis Antwerpen
        • Kontakt:
      • Jette, Belgien, 1090
        • Ikke rekrutterer endnu
        • Universitair Ziekenhuis Brussel
        • Kontakt:
      • Leuven, Belgien, 3000
  • Brasilien
      • Barretos, Brasilien, 14784-400
      • Porto Alegre, Brasilien, 90110-270
        • Rekruttering
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples
        • Kontakt:
      • Porto Alegre - RS, Brasilien, CEP 90020-090
        • Rekruttering
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Kontakt:
      • São José do Rio Preto, Brasilien, 15090-000
        • Rekruttering
        • Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
        • Kontakt:
  • Bulgarien
      • Panagyurishte, Bulgarien, 4500
        • Ikke rekrutterer endnu
        • Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
        • Kontakt:
      • Pleven, Bulgarien, 5800
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Ikke rekrutterer endnu
        • Verspeeten Family Cancer Centre (LHSC)
        • Kontakt:
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Ikke rekrutterer endnu
        • Sault Area Hospital
        • Kontakt:
  • Chile
      • La Florida, Chile, 8240000
      • Providencia, Chile
        • Rekruttering
        • Instituto Oncologico FALP
        • Kontakt:
      • Providencia, Chile
        • Rekruttering
        • Clinica Santa Maria
        • Kontakt:
      • Recoleta, Chile, 8420383
        • Rekruttering
        • Bradford Hill- Centro de Investigacion Clinica
        • Kontakt:
      • Santiago, Chile, 7650568
        • Rekruttering
        • Clinica Alemana de Santiago S.A.
        • Kontakt:
  • Det Forenede Kongerige
      • Cardiff, Det Forenede Kongerige, CF14 2TL
      • Leicester, Det Forenede Kongerige, LE1 5WW
      • Manchester, Det Forenede Kongerige, M20 4BX
      • Sutton, Det Forenede Kongerige, SM2 5PT
      • Torquay, Det Forenede Kongerige, TQ2 7AA
  • Estland
      • Tallinn, Estland, 13419
        • Ikke rekrutterer endnu
        • North Estonia Medical Centre Foundation, Tallinn
        • Kontakt:
      • Tartu, Estland, 50406
        • Ikke rekrutterer endnu
        • Tartu University Hospital
        • Kontakt:
  • Finland
      • Kuopio, Finland, 70029
        • Rekruttering
        • KYS Sädesairaala
        • Kontakt:
      • Oulu, Finland, 90220
        • Rekruttering
        • Oulun yliopistollinen keskussairaala
        • Kontakt:
      • Turku, Finland, 20521
        • Rekruttering
        • Turun Yliopistollinen sairaala
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36607
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Ikke rekrutterer endnu
        • University of Arkansas for Medical Sciences
        • Kontakt:
    • Florida
      • Hialeah, Florida, Forenede Stater, 33013
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
      • Pikeville, Kentucky, Forenede Stater, 41501
    • Louisiana
      • Monroe, Louisiana, Forenede Stater, 71201
      • Shreveport, Louisiana, Forenede Stater, 71105
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48105
        • Ikke rekrutterer endnu
        • Veterans Affairs Ann Arbor Healthcare System
        • Kontakt:
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64132
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
    • North Carolina
      • Fayetteville, North Carolina, Forenede Stater, 28303
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
  • Frankrig
      • Angers, Frankrig, 49055
        • Ikke rekrutterer endnu
        • INS Cancérologie de l'Ouest
        • Kontakt:
      • Bordeaux, Frankrig, 33000
      • Caen, Frankrig, 14076
        • Rekruttering
        • CTR François Baclesse
        • Kontakt:
      • Dijon, Frankrig, 21079
        • Ikke rekrutterer endnu
        • CTR Georges-François Leclerc
        • Kontakt:
      • Nantes, Frankrig, 44093
      • Paris, Frankrig, 75014
      • Paris, Frankrig, 75005
      • Toulouse, Frankrig, 31059
        • Ikke rekrutterer endnu
        • Hôpital Larrey - CHU de Toulouse
        • Kontakt:
      • Villefranche-sur-Saône, Frankrig, 69400
        • Rekruttering
        • HOP Villefranche-sur-Saône
        • Kontakt:
      • Villejuif, Frankrig, 94800
        • Rekruttering
        • Institut Gustave Roussy
        • Kontakt:
  • Georgien
      • Tbilisi, Georgien, 0112
  • Grækenland
      • Athens, Grækenland, 115 27
        • Ikke rekrutterer endnu
        • Chest Hospital of Athens "Sotiria"
        • Kontakt:
      • Athens, Grækenland, 11526
        • Rekruttering
        • Henry Dunant Hospital, Athens
        • Kontakt:
      • Thessaloniki, Grækenland, 57010
        • Rekruttering
        • General Hospital of Thessaloniki "G. Papanikolaou"
        • Kontakt:
  • Holland
      • Amsterdam, Holland, 1066CX
        • Rekruttering
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
        • Kontakt:
      • Maastricht, Holland, 6229 HX
        • Rekruttering
        • Maastricht University Medisch Centrum
        • Kontakt:
      • Rotterdam, Holland, 3015 GD
  • Hong Kong
      • Hong Kong, Hong Kong
      • Shatin, Hong Kong, 999077
        • Rekruttering
        • Prince of Wales Hospital-Hong Kong-20715
        • Kontakt:
  • Irland
      • Cork, Irland, T12 DFK4
  • Italien
      • Aviano (PN), Italien, 33081
        • Rekruttering
        • Centro di riferimento Oncologico
        • Kontakt:
      • Bari, Italien, 70124
        • Ikke rekrutterer endnu
        • Istituto Tumori Giovanni Paolo II
        • Kontakt:
      • Brescia, Italien, 25123
        • Ikke rekrutterer endnu
        • ASST degli Spedali Civili di Brescia
        • Kontakt:
      • Florence, Italien, 50134
        • Rekruttering
        • A. O. Universitaria Careggi
        • Kontakt:
      • Meldola (FC), Italien, 47014
        • Rekruttering
        • Istituto Scientifico Romagnolo
        • Kontakt:
      • Orbassano (TO), Italien, 10043
        • Ikke rekrutterer endnu
        • AOU San Luigi Gonzaga
        • Kontakt:
      • Padova, Italien, 35128
        • Ikke rekrutterer endnu
        • Istituto Oncologico Veneto IRCCS
        • Kontakt:
      • Parma, Italien, 43100
        • Ikke rekrutterer endnu
        • Azienda Ospedaliera Unversitaria di Parma
        • Kontakt:
      • Roma, Italien, 00128
        • Rekruttering
        • Fondazione Policlinico Universitario Campus Bio-medico
        • Kontakt:
      • Verona, Italien, 37126
        • Rekruttering
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Kontakt:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Rekruttering
        • Fujita Health University Hospital
        • Kontakt:
      • Aomori, Hirosaki, Japan, 036-8563
        • Rekruttering
        • Hirosaki University Hospital
        • Kontakt:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Rekruttering
        • Kyushu University Hospital
        • Kontakt:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Rekruttering
        • Hokkaido University Hospital
        • Kontakt:
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Rekruttering
        • Kagoshima University Hospital
        • Kontakt:
      • Miyagi, Sendai, Japan, 981-0914
        • Rekruttering
        • Sendai Kousei Hospital
        • Kontakt:
      • Osaka, Sakai, Japan, 590-0197
        • Rekruttering
        • Kindai University Hospital
        • Kontakt:
      • Saitama, Hidaka, Japan, 350-1298
        • Rekruttering
        • Saitama Medical University International Medical Center
        • Kontakt:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Rekruttering
        • Hamamatsu University Hospital
        • Kontakt:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Ikke rekrutterer endnu
        • National Cancer Center Hospital
        • Kontakt:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Rekruttering
        • Japanese Foundation for Cancer Research
        • Kontakt:
      • Wakayama, Wakayama, Japan, 641-8510
        • Rekruttering
        • Wakayama Medical University Hospital
        • Kontakt:
  • Kina
      • Beijing, Kina, 100036
        • Rekruttering
        • Beijing Cancer Hospital
        • Kontakt:
      • Beijing, Kina, 101149
        • Rekruttering
        • Beijing Chest Hospital, Capital Medical University
        • Kontakt:
      • Bengbu, Kina, 233004
        • Rekruttering
        • The First Affiliated Hospital Of Bengbu Medical College
        • Kontakt:
      • Changsha, Kina, 410013
        • Ikke rekrutterer endnu
        • Hunan Province Tumor Hospital
        • Kontakt:
      • Chengdu, Kina, 610041
        • Rekruttering
        • Sichuan Cancer Hospital
        • Kontakt:
      • Chengdu, Kina, 610041
        • Afsluttet
        • West China Hospital, Sichuan University
      • Fuzhou, Kina, 350014
        • Rekruttering
        • Fujian Cancer Hospital
        • Kontakt:
      • Guangzhou, Kina, 510080
        • Rekruttering
        • The First Affiliated Hospital,Sun Yat-sen University
        • Kontakt:
      • Guangzhou, Kina, 510060
        • Rekruttering
        • Sun Yat-Sen University Cancer Center
        • Kontakt:
      • Hangzhou, Kina, 310016
        • Rekruttering
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Kontakt:
      • Hangzhou, Kina, 310003
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital, Zhejiang University
        • Kontakt:
      • Harbin, Kina, 150081
        • Ikke rekrutterer endnu
        • Harbin Medical University Cancer Hospital
        • Kontakt:
      • Jinan, Kina, 250117
        • Rekruttering
        • Shandong Cancer Hospital
        • Kontakt:
      • Linyi, Kina, 276034
        • Rekruttering
        • Linyi Cancer Hospital
        • Kontakt:
      • Nanchang, Kina, 330006
        • Rekruttering
        • The Second Affiliated Hospital to Nanchang University
        • Kontakt:
      • Nanchang, Kina, 330000
        • Rekruttering
        • The First Affiliated Hospital of Nanchang University
        • Kontakt:
      • Nanjing, Kina, 210008
        • Rekruttering
        • Nanjing Drum Tower Hospital
        • Kontakt:
      • Nanning, Kina, 530021
        • Rekruttering
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Kontakt:
      • Ningbo, Kina, 315010
        • Rekruttering
        • The First Affiliated Hospital of Ningbo University
        • Kontakt:
      • Shanghai, Kina, 200433
        • Rekruttering
        • Shanghai Pulmonary Hospital
        • Kontakt:
      • Shanghai, Kina, 200030
        • Rekruttering
        • Shanghai Chest Hospital
        • Kontakt:
      • Shanghai, Kina, 201104
        • Rekruttering
        • Shanghai Geriatric Medical Center
        • Kontakt:
      • Shanghai, Kina, 210000
        • Rekruttering
        • Shanghai General Hospital
        • Kontakt:
      • Shenyang, Kina, 110000
        • Rekruttering
        • China Shenyang Chest Hospital
        • Kontakt:
      • Taiyuan, Kina, 030000
        • Ikke rekrutterer endnu
        • Shanxi Cancer hospital
        • Kontakt:
      • Tianjin, Kina, 300060
        • Rekruttering
        • Tianjin Cancer Hospital
        • Kontakt:
      • Wenzhou, Kina, 325000
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
      • Wuhan, Kina, 430048
        • Rekruttering
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Kontakt:
      • Xiangyang, Kina, 441138
        • Rekruttering
        • Xiangyang Central Hospital
        • Kontakt:
      • Xuzhou, Kina, 221006
        • Rekruttering
        • The Affiliated Hospital of Xuzhou Medical College
        • Kontakt:
      • Yangzhou, Kina, 225001
        • Rekruttering
        • Northern Jiangsu People's Hospital
        • Kontakt:
      • Zhengzhou, Kina, 450003
        • Ikke rekrutterer endnu
        • Henan Cancer Hospital
        • Kontakt:
      • Zhengzhou, Kina, 450015
        • Rekruttering
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
  • Letland
      • Riga, Letland, 1002
        • Ikke rekrutterer endnu
        • Pauls Stradins Clinical University Hospital
        • Kontakt:
      • Riga, Letland, 1079
        • Ikke rekrutterer endnu
        • Rigas Austrumu kliniska universitates slimnica SIA
        • Kontakt:
  • Malaysia
      • George Town, Malaysia, 10450
        • Rekruttering
        • Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766
        • Kontakt:
      • Kota Kinabalu, Malaysia, 88996
        • Rekruttering
        • Hospital Wanita Dan Kanak-Kanak Sabah
        • Kontakt:
      • Kuching, Malaysia, 93586
      • Putrajaya, Malaysia, 62250
        • Rekruttering
        • National Cancer Institute (IKN)
        • Kontakt:
      • Selangor Darul Ehsan, Malaysia, 47500
  • Mexico
      • Guadalajara, Jalisco, Mexico, 44329
        • Ikke rekrutterer endnu
        • Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente
        • Kontakt:
      • Mexico City, Mexico, 03100
        • Ikke rekrutterer endnu
        • Health Pharma Professional Research S.A. de C.V.
        • Kontakt:
      • Monterrey, Mexico, 66278
        • Ikke rekrutterer endnu
        • Centro Medico Zambrano Hellion
        • Kontakt:
      • México, Mexico, 06760
        • Ikke rekrutterer endnu
        • Centro Oncologico Personalizado
        • Kontakt:
      • México, Mexico, 14080
        • Ikke rekrutterer endnu
        • Instituto Nacional de Cancerologia
        • Kontakt:
      • Nuevo León, Mexico, 64460
        • Ikke rekrutterer endnu
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Kontakt:
      • Toluca, Mexico, 50180
        • Ikke rekrutterer endnu
        • Centro Oncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"
        • Kontakt:
  • Moldova
      • Chisinau, Moldova, MD-2025
        • Rekruttering
        • ARENSIA Exploratory Medicine
        • Kontakt:
  • New Zealand
      • Auckland, New Zealand, 1023
      • Hamilton, New Zealand, 3204
  • Norge
      • Bergen, Norge, 5021
        • Rekruttering
        • Haukeland Universitetssykehus
        • Kontakt:
      • Oslo, Norge, N-0379
        • Rekruttering
        • Oslo Universitetssykehus HF, Radiumhospitalet
        • Kontakt:
      • Trondheim, Norge, 7030
        • Rekruttering
        • St. Olavs Hospital, Universitetssykehuset i Trondheim
        • Kontakt:
  • Polen
      • Gdansk, Polen, 80-214
        • Rekruttering
        • UCK Clinical Research Support Center
        • Kontakt:
      • Lodz, Polen, 93338
        • Rekruttering
        • Polish Mother's Memorial Hospital - Research Institute
        • Kontakt:
      • Lublin, Polen, 20090
        • Ikke rekrutterer endnu
        • University Clinical Hospital No. 4 in Lublin
        • Kontakt:
      • Olsztyn, Polen, 10-357
        • Ikke rekrutterer endnu
        • Warmia and Mazury Center for Lung Diseases in Olsztyn
        • Kontakt:
  • Portugal
      • Braga, Portugal, 4710-243
      • Coimbra, Portugal, 3004-561
        • Ikke rekrutterer endnu
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Kontakt:
      • Lisbon, Portugal, 1500-650
      • Porto, Portugal, 4100-180
      • Porto, Portugal, 4200-072
        • Ikke rekrutterer endnu
        • IPO Porto Francisco Gentil, EPE
        • Kontakt:
  • Rumænien
      • Bucharest, Rumænien, 022328
        • Rekruttering
        • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
        • Kontakt:
      • Cluj-Napoca, Rumænien, 400015
        • Rekruttering
        • Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
        • Kontakt:
      • Craiova, Rumænien, 200542
        • Ikke rekrutterer endnu
        • Centrul De Oncologie SF Nectarie S.R.L.
        • Kontakt:
  • Schweiz
      • Baden, Schweiz, 5404
        • Ikke rekrutterer endnu
        • Kantonsspital Baden AG
        • Kontakt:
      • Lausanne, Schweiz, 1011
        • Ikke rekrutterer endnu
        • Centre Hospitalier Universitaire Vaudois
        • Kontakt:
  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 168583
        • Rekruttering
        • National Cancer Centre Singapore
        • Kontakt:
  • Spanien
      • A Coruña, Spanien, 15006
        • Rekruttering
        • Complejo Hospitalario Universitario A Coruña
        • Kontakt:
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
      • Barcelona, Spanien, 08003
      • Girona, Spanien, 17007
        • Rekruttering
        • Institut Català d'Oncologia de Girona.
        • Kontakt:
      • L'Hospitalet de Llobregat, Spanien, 08908
        • Rekruttering
        • Hospital Duran i Reynals
        • Kontakt:
      • Las Palmas de Gran Canaria, Spanien, 35016
        • Rekruttering
        • H. Universitario Insular de Canarias
        • Kontakt:
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
        • Kontakt:
      • Madrid, Spanien, 28040
        • Rekruttering
        • Fundación Jiménez Díaz
        • Kontakt:
      • Madrid, Spanien, 28222
        • Rekruttering
        • Hospital Puerta de Hierro
        • Kontakt:
      • Madrid, Spanien, 28034
        • Rekruttering
        • Hospital Universitario Ramon Y Cajal
        • Kontakt:
      • Málaga, Spanien, 29010
        • Rekruttering
        • Hospital Regional Universitario de Malaga
        • Kontakt:
      • Palma de Mallorca, Spanien, 07120
        • Rekruttering
        • Hospital Universitari Son Espases
        • Kontakt:
      • Pamplona, Spanien, 31008
        • Rekruttering
        • Clínica Universidad de Navarra
        • Kontakt:
      • Seville, Spanien, 41009
        • Rekruttering
        • Hospital Universitario Virgen De La Macarena
        • Kontakt:
      • Valencia, Spanien, 46010
        • Rekruttering
        • Hospital Clinico Universitario de Valencia
        • Kontakt:
      • Valencia, Spanien, 46016
        • Rekruttering
        • Hospital Universitari i Politècnic La Fe
        • Kontakt:
      • Zaragoza, Spanien, 50009
        • Rekruttering
        • Hospital Clinico Universitario Lozano Blesa
        • Kontakt:
  • Sverige
      • Gothenburg, Sverige, 413 46
        • Rekruttering
        • Sahlgrenska Universitetssjukhuset, Östra
        • Kontakt:
      • Gävle, Sverige, 801 87
      • Stockholm, Sverige, 171 76
        • Rekruttering
        • Karolinska Universitetssjukhuset Solna
        • Kontakt:
  • Sydkorea
      • Busan, Sydkorea, 49241
        • Rekruttering
        • Pusan National University Hospital
        • Kontakt:
      • Daejoen, Sydkorea, 35015
        • Rekruttering
        • Chungnam National University Hospital
        • Kontakt:
      • Goyang, Sydkorea, 10408
        • Rekruttering
        • National Cancer Center
        • Kontakt:
      • Hwasun, Sydkorea, 58128
        • Rekruttering
        • Chonnam National University Hwasun Hospital
        • Kontakt:
      • Seongnam, Sydkorea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:
      • Seoul, Sydkorea, 05505
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
      • Seoul, Sydkorea, 06351
        • Rekruttering
        • Samsung Medical Center
        • Kontakt:
      • Seoul, Sydkorea, 03722
      • Seoul, Sydkorea, 08308
        • Rekruttering
        • Korea University Guro Hospital
        • Kontakt:
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Rekruttering
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Kontakt:
      • Taichung, Taiwan, 40705
        • Rekruttering
        • Taichung Veterans General Hospital
        • Kontakt:
      • Tainan, Taiwan, 70403
        • Rekruttering
        • National Cheng Kung University Hospital
        • Kontakt:
      • Taipei, Taiwan, 11217
        • Rekruttering
        • Taipei Veterans General Hospital
        • Kontakt:
      • Taipei, Taiwan, 10048
        • Rekruttering
        • National Taiwan University Hospital
        • Kontakt:
      • Taipei, Taiwan, 106
        • Ikke rekrutterer endnu
        • National Taiwan University Cancer Center
        • Kontakt:
      • Taoyuan City, Taiwan, 333
        • Rekruttering
        • Chang Gung Memorial Hospital, Linkou
        • Kontakt:
  • Thailand
      • Bangkok, Thailand, 10700
        • Rekruttering
        • Siriraj Hospital
        • Kontakt:
      • Bangkok, Thailand, 10300
        • Rekruttering
        • Vajira Hospital
        • Kontakt:
      • Chiang Mai, Thailand, 50200
        • Rekruttering
        • Maharaj Nakom Chiangmai Hospital
        • Kontakt:
      • Hat Yai, Thailand, 90110
        • Rekruttering
        • Songklanagarind Hospital
        • Kontakt:
  • Tjekkiet
      • Olomouc, Tjekkiet, 77900
        • Ikke rekrutterer endnu
        • University Hospital Olomouc
        • Kontakt:
      • Prague, Tjekkiet, 140 59
        • Ikke rekrutterer endnu
        • University Thomayer´s Hospital
        • Kontakt:
  • Tyrkiet (Türkiye)
      • Adana, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Adana Şehir Hastanesi
        • Kontakt:
      • Adana, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Medical Park Adana Hastanesi
        • Kontakt:
      • Ankara, Tyrkiet (Türkiye), 06018
        • Ikke rekrutterer endnu
        • Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
        • Kontakt:
      • Ankara, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
        • Kontakt:
      • Ankara, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Ankara Liv Hastanesi
        • Kontakt:
      • Atakum, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Samsun Medical Park Hastanesi
        • Kontakt:
      • Istanbul, Tyrkiet (Türkiye), 34862
        • Ikke rekrutterer endnu
        • Medeniyet University
        • Kontakt:
      • Istanbul, Tyrkiet (Türkiye), 34890
        • Ikke rekrutterer endnu
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
        • Kontakt:
      • Türkiye, Tyrkiet (Türkiye)
        • Ikke rekrutterer endnu
        • Ankara Bilkent Sehir Hastanesi
        • Kontakt:
  • Tyskland
      • Aachen, Tyskland, 52074
      • Berlin, Tyskland, 13353
        • Ikke rekrutterer endnu
        • Charité - Universitätsmedizin Berlin
        • Kontakt:
      • Berlin-Spandau, Tyskland, 13585
      • Dresden, Tyskland, 01307
      • Essen, Tyskland, 45147
        • Ikke rekrutterer endnu
        • Universitätsklinikum Essen AöR
        • Kontakt:
      • Frankfurt, Tyskland, 60590
      • Freiburg im Breisgau, Tyskland, 79106
        • Ikke rekrutterer endnu
        • Universitätsklinikum Freiburg
        • Kontakt:
      • Gauting, Tyskland, 82131
        • Rekruttering
        • Asklepios Fachkliniken München-Gauting
        • Kontakt:
      • Großhansdorf, Tyskland, 22927
        • Ikke rekrutterer endnu
        • LungenClinic Grosshansdorf GmbH
        • Kontakt:
      • Göttingen, Tyskland, 37075
        • Ikke rekrutterer endnu
        • Universitätsmedizin Göttingen, Georg-August-Universität
        • Kontakt:
      • Hamburg, Tyskland, 21075
      • Heidelberg, Tyskland, 69126
        • Rekruttering
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Kontakt:
      • Münster, Tyskland, 48149
        • Ikke rekrutterer endnu
        • Westfälische Wilhelms-Universität Münster
        • Kontakt:
      • Oldenburg, Tyskland, 26121
      • Würzburg, Tyskland, 97078
  • Ungarn
      • Budapest, Ungarn, 1121
        • Ikke rekrutterer endnu
        • Koranyi National Institute For Pulmonolgy
        • Kontakt:
      • Debrecen, Ungarn, 4032
      • Gyula, Ungarn, 5700
      • Kecskemét, Ungarn, 6000
        • Ikke rekrutterer endnu
        • Bacs-Kiskun Megyei Onkormanyzat Hospital
        • Kontakt:
      • Szekszárd, Ungarn, 7100
        • Ikke rekrutterer endnu
        • Tolna County Balassa Janos Hospital
        • Kontakt:
      • Törökbálint, Ungarn, 2045
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Ikke rekrutterer endnu
        • Hanoi Oncology Hospital
        • Kontakt:
      • Hanoi, Vietnam, 100000
        • Ikke rekrutterer endnu
        • Vietnam National Cancer Hospital
        • Kontakt:
      • Ho Chi Minh City, Vietnam, 70000
        • Ikke rekrutterer endnu
        • University Medical Center HCMC
        • Kontakt:
      • Ho Chi Minh City, Vietnam, 70000
        • Ikke rekrutterer endnu
        • Ho Chi Minh Oncology Hospital
        • Kontakt:
  • Østrig
      • Linz, Østrig, 4020
      • Linz, Østrig, 4020
      • Vienna, Østrig, 1160

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria :

  1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)

  2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.

  3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.

  4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:

    • Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation
    • Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation

  5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

  6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy

  7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.

Exclusion Criteria :

  1. Presence of leptomeningeal disease and/or carcinomatous meningitis
  2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
  3. Radiotherapy of any anatomical site within 7 days prior to randomisation
  4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described
  5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.

Further exclusion criteria apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: obrixtamig + atezolizumab, carboplatin og etoposide behandlingsarm
Medicin: obrixtamig

obrixtamig

Medicin: atezolizumab

atezolizumab

Medicin: carboplatin

carboplatin

Medicin: etoposide

etoposide
Eksperimentel: atezolizumab, carboplatin og etoposide kontrolarm
Medicin: atezolizumab

atezolizumab

Medicin: carboplatin

carboplatin

Medicin: etoposide

etoposide

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: Up to 36 months

OS, defined as the time from randomisation until death from any cause
Up to 36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst af behandlingsinduceret cytokinfrigivelsessyndrom (CRS) i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder
Op til 36 måneder
Forekomst af behandlingsrelateret immun effektor-celle-associeret neurotoksisitetsyndrom (ICANS) i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder
Op til 36 måneder
Forekomst af behandlingsrelaterede bivirkninger (AEs), der fører til afbrydelse af forsøgsmedicin under behandlingsperioden
Tidsramme: Op til 36 måneder
Op til 36 måneder
Forekomst af behandlingsrelaterede bivirkninger, der fører til forsinkelse i doseringen af forsøgsmedicinen i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder
Op til 36 måneder
Forekomst af behandlingsrelaterede bivirkninger, der fører til dosisreduktion af prøvemedicinen i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder
Op til 36 måneder
Progression free survival (PFS)
Tidsramme: Up to 36 months

PFS, defined as the time from randomisation until the earliest date of tumour progression according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on investigator assessments or death from any cause
Up to 36 months
Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Tidsramme: At baseline and up to 1 year

EORTC QLQ-LC13: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire lung cancer-specific 13-item questionnaire module (QLQ-LC13) includes one multi-item scale (dyspnoea, based on three items) and ten single-item measures capturing symptoms such as coughing, haemoptysis, pain, and treatment-related toxicities including sore mouth, dysphagia, and peripheral neuropathy. All QLQ-LC13 items are scored on a 4-point Likert scale (1 = "not at all," 4 = "very much"). All QLQ-LC13 scores range from 0 to 100, with higher scores indicating greater symptom burden or more severe problems
At baseline and up to 1 year
Overall response (OR)
Tidsramme: Up to 36 months

OR, defined as a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (based on investigator assessments) from the date of randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent
Up to 36 months
Time to deterioration (TTD), defined as time from randomisation to deterioration maintained for 2 consecutive assessments or 1 assessment followed by death from any cause within 3 weeks
Tidsramme: Up to 3 weeks

Assessments are a composite of the following European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ EORTC) scores:

  • Dyspnea as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13
  • Chest pain as measured by EORTC-QLQ-LC13
  • Cough as measured by EORTC-QLQ-LC13 These questionnaires request scores on global health status, functioning, symptoms, as well as single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.

All scores range from 0 to 100. For scores regarding functioning and global quality of life, higher scores represent better functioning and better quality of life. For scores regarding symptom scales higher scores indicate greater symptom burden.
Up to 3 weeks
Change From Baseline in Symptom Severity as Measured by scales of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13
Tidsramme: At baseline and up to 1 year

EORTC QLQ-LC13: EORTC Quality of Life Questionnaire lung cancer-specific 13-item questionnaire module (QLQ-LC13) includes one multi-item scale (dyspnoea, based on three items) and ten single-item measures capturing symptoms such as coughing, haemoptysis, pain, and treatment-related toxicities including sore mouth, dysphagia, and peripheral neuropathy. All QLQ-LC13 items are scored on a 4-point Likert scale (1 = "not at all," 4 = "very much"). All QLQ-LC13 scores range from 0 to 100, with higher scores indicating greater symptom burden or more severe problems
At baseline and up to 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. april 2026

Primær færdiggørelse (Anslået)

9. september 2028

Studieafslutning (Anslået)

30. juli 2029

Datoer for studieregistrering

Først indsendt

4. marts 2026

Først indsendt, der opfyldte QC-kriterier

13. marts 2026

Først opslået (Faktiske)

16. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1438-0012
  • 2025-520565-51-00 (Registry Identifier: CTIS)
  • U1111-1317-4955 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-delingsadgangskriterier

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner