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DAREON ® -Lung-1: En studie hos personer med avansert småcellet lungekreft for å sammenligne obrixtamig pluss atezolizumab, karboplatin og etoposid-behandling med standard kjemoterapi

9. november 2026 oppdatert av: Boehringer Ingelheim

DAREON ® -Lung-1: En fase III, multikenter, åpen merket, randomisert studie av intravenøs obrixtamig i kombinasjon med atezolizumab, karboplatin og etoposid vs. atezolizumab, karboplatin og etoposid som førstelinjebehandling hos pasienter med utbredt småcellet lungekreft

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

670

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: obrixtamig + atezolizumab, karboplatin og etoposid behandlingsarm
Legemiddel: obrixtamig

obrixtamig

Legemiddel: atezolizumab

atezolizumab

Legemiddel: carboplatin

carboplatin

Legemiddel: etoposide

etoposide
Eksperimentell: atezolizumab, carboplatin og etoposide kontrollgruppe
Legemiddel: atezolizumab

atezolizumab

Legemiddel: carboplatin

carboplatin

Legemiddel: etoposide

etoposide

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Forekomst av behandlingsrelatert Cytokinutløsningssyndrom (CRS) i løpet av behandlingsperioden
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Forekomst av behandlingsrelatert immun effektor-celle-assosiert nevrotoksisk syndrom (ICANS) under behandlingsperioden
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Forekomst av behandlingsrelaterte bivirkninger (AEs) som fører til avbrudd av prøvemedikament under behandlingsperioden
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Forekomst av behandlingsrelaterte bivirkninger som fører til forsinkelse i prøvemedisin-dosen under behandlingsperioden
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Forekomst av behandlingsrelaterte bivirkninger som fører til dosejustering av prøvemedisin i løpet av behandlingsperioden
Tidsramme: Opptil 36 måneder
Opptil 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. april 2026

Primær fullføring (Antatt)

9. september 2028

Studiet fullført (Antatt)

30. juli 2029

Datoer for studieregistrering

Først innsendt

4. mars 2026

Først innsendt som oppfylte QC-kriteriene

13. mars 2026

Først lagt ut (Faktiske)

16. mars 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere