DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy

May 28, 2026 updated by: Boehringer Ingelheim

DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

670

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, 1430
        • Not yet recruiting
        • Clinica Adventista Belgrano
        • Contact:
      • CABA, Argentina, 1280AEB
        • Not yet recruiting
        • Hospital Británico de Buenos Aires
        • Contact:
      • Munro, Argentina, B1605
        • Not yet recruiting
        • Clinica Privada Independencia
        • Contact:
      • Nueva Córdoba, Argentina, X5000JHQ
      • Rosario, Argentina, S2000DSV
  • Australia
      • Adelaide, Australia
        • Not yet recruiting
        • Cancer Research South Australia
        • Contact:
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Not yet recruiting
        • Prince of Wales Hospital-Randwick-66496
        • Contact:
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Not yet recruiting
        • Ballarat Regional Integrated Cancer Centre
        • Contact:
  • Austria
      • Linz, Austria, 4020
      • Linz, Austria, 4020
      • Vienna, Austria, 1160
        • Not yet recruiting
        • Standort Penzing der Klinik Ottakring
        • Contact:
  • Belgium
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Edegem - UNIV UZ Antwerpen
        • Contact:
      • Jette, Belgium, 1090
        • Not yet recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
      • Leuven, Belgium, 3000
  • Brazil
      • Barretos, Brazil, 14784-400
        • Not yet recruiting
        • Hospital de Amor
        • Contact:
      • Porto Alegre - RS, Brazil, CEP 90020-
        • Not yet recruiting
        • Irmandade Da Santa Casa de Misericórdia de Porto Alegre
        • Contact:
      • São José do Rio Preto, Brazil, 15090-000
        • Not yet recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
  • Bulgaria
      • Panagyurishte, Bulgaria, 4500
        • Not yet recruiting
        • Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
        • Contact:
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1407
        • Not yet recruiting
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
        • Contact:
  • Canada
    • Ontario
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Not yet recruiting
        • Sault Area Hospital
        • Contact:
  • Chile
      • La Florida, Chile, 8240000
      • Providencia, Chile
        • Not yet recruiting
        • Clinica Santa Maria
        • Contact:
      • Providencia, Chile
        • Not yet recruiting
        • Instituto Oncológico FALP
        • Contact:
      • Recoleta, Chile, 8420383
        • Not yet recruiting
        • Bradford Hill- Centro de Investigación Clínica
        • Contact:
      • Santiago, Chile, 7650568
        • Not yet recruiting
        • Clínica Alemana de Santiago S.A.
        • Contact:
  • China
      • Beijing, China, 101149
        • Not yet recruiting
        • Beijing Chest Hospital, Capital Medical University
        • Contact:
      • Beijing, China, 100036
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Bengbu, China, 233004
        • Not yet recruiting
        • The First Affiliated Hospital Of Bengbu Medical College
        • Contact:
      • Changsha, China, 410013
        • Not yet recruiting
        • Hunan Province Tumor Hospital
        • Contact:
      • Chengdu, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Fuzhou, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Guangzhou, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Hangzhou, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hangzhou, China, 310016
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Harbin, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
      • Jinan, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Linyi, China, 276034
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
      • Nanchang, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Nanchang, China, 330000
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanning, China, 530021
        • Not yet recruiting
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Contact:
      • Ningbo, China, 315010
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, China, 200433
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, China, 201104
        • Not yet recruiting
        • Shanghai Geriatric Medical Center
        • Contact:
      • Shanghai, China, 210000
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
      • Shenyang, China, 110000
        • Not yet recruiting
        • China Shenyang Chest Hospital
        • Contact:
      • Taiyuan, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
      • Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Cancer Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430048
        • Not yet recruiting
        • Wuhan Union Hospital
        • Contact:
      • Xiangyang, China, 441138
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
      • Xuzhou, China, 221006
        • Not yet recruiting
        • Affiliated Hospital, Xuzhou Medical college
        • Contact:
      • Yangzhou, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
      • Zhengzhou, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, China, 450015
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
  • Czechia
      • Olomouc, Czechia, 77900
        • Not yet recruiting
        • University Hospital Olomouc
        • Contact:
      • Prague, Czechia, 140 59
        • Not yet recruiting
        • University Thomayer´s Hospital
        • Contact:
  • Estonia
      • Tallinn, Estonia, 13419
        • Not yet recruiting
        • North Estonia Medical Centre Foundation, Tallinn
        • Contact:
      • Tartu, Estonia, 50406
        • Not yet recruiting
        • Tartu University Hospital
        • Contact:
  • Finland
      • Kuopio, Finland, 70029
        • Not yet recruiting
        • KYS Sädesairaala
        • Contact:
      • Oulu, Finland, 90220
        • Not yet recruiting
        • Oulun yliopistollinen keskussairaala
        • Contact:
      • Turku, Finland, 20521
        • Not yet recruiting
        • Turun Yliopistollinen sairaala
        • Contact:
  • France
      • Bordeaux, France, 33000
      • Caen, France, 14076
        • Not yet recruiting
        • CTR François Baclesse
        • Contact:
      • Dijon, France, 21079
        • Not yet recruiting
        • CTR Georges-François Leclerc
        • Contact:
      • Marseille, France, 13009
        • Not yet recruiting
        • INS Paoli-Calmettes
        • Contact:
      • Nantes, France, 44093
        • Not yet recruiting
        • HOP Nord Laennec
        • Contact:
      • Paris, France, 75014
      • Paris, France, 75005
      • Villefranche-sur-Saône, France, 69400
        • Not yet recruiting
        • HOP Villefranche-sur-Saône
        • Contact:
      • Villejuif, France, 94800
        • Not yet recruiting
        • Institut Gustave Roussy
        • Contact:
  • Georgia
      • Tbilisi, Georgia, 0112
  • Germany
      • Aachen, Germany, 52074
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Charite - Universitatsmedizin Berlin
        • Contact:
      • Berlin-Spandau, Germany, 13585
      • Dresden, Germany, 01307
      • Frankfurt, Germany, 60590
      • Freiburg im Breisgau, Germany, 79106
      • Gauting, Germany, 82131
        • Not yet recruiting
        • Asklepios Fachkliniken München-Gauting
        • Contact:
      • Großhansdorf, Germany, 22927
      • Göttingen, Germany, 37075
        • Not yet recruiting
        • Universitätsmedizin Göttingen, Georg-August-Universität
        • Contact:
      • Hamburg, Germany, 21075
      • Heidelberg, Germany, 69126
        • Not yet recruiting
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Contact:
      • Münster, Germany, 48149
        • Not yet recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
      • Oldenburg, Germany, 26121
      • Würzburg, Germany, 97078
        • Not yet recruiting
        • Universitätsklinikum Würzburg AÖR
        • Contact:
  • Greece
      • Athens, Greece, 11526
        • Not yet recruiting
        • Henry Dunant Hospital, Athens
        • Contact:
      • Athens, Greece, 115 27
        • Not yet recruiting
        • Chest Hospital of Athens "Sotiria"
        • Contact:
      • Thessaloniki, Greece, 57010
        • Not yet recruiting
        • General Hospital of Thessaloniki "G. Papanikolaou"
        • Contact:
  • Hong Kong
      • Hong Kong, Hong Kong
      • Shatin, Hong Kong, 999077
        • Not yet recruiting
        • Prince of Wales Hospital-Hong Kong-20715
        • Contact:
  • Hungary
      • Budapest, Hungary, 1121
        • Not yet recruiting
        • Koranyi National Institute For Pulmonolgy
        • Contact:
      • Debrecen, Hungary, 4032
      • Kecskemét, Hungary, 6000
      • Szekszárd, Hungary, 7100
      • Törökbálint, Hungary, 2045
  • Ireland
      • Cork, Ireland, T12 DFK4
  • Italy
      • Aviano (PN), Italy, 33081
        • Not yet recruiting
        • Centro di riferimento Oncologico
        • Contact:
      • Bari, Italy, 70124
        • Not yet recruiting
        • Istituto Tumori Giovanni Paolo II
        • Contact:
      • Brescia, Italy, 25123
        • Not yet recruiting
        • ASST degli Spedali Civili di Brescia
        • Contact:
      • Florence, Italy, 50134
        • Not yet recruiting
        • A. O. Universitaria Careggi
        • Contact:
      • Meldola (FC), Italy, 47014
        • Not yet recruiting
        • Istituto Scientifico Romagnolo
        • Contact:
      • Orbassano (TO), Italy, 10043
        • Not yet recruiting
        • AOU San Luigi Gonzaga
        • Contact:
      • Padova, Italy, 35128
        • Not yet recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
      • Parma, Italy, 43100
        • Not yet recruiting
        • Azienda Ospedaliera Unversitaria di Parma
        • Contact:
      • Roma, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-medico
        • Contact:
      • Verona, Italy, 37126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
      • Aomori, Hirosaki, Japan, 036-8563
        • Not yet recruiting
        • Hirosaki University Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Not yet recruiting
        • Kagoshima University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 981-0914
        • Not yet recruiting
        • Sendai Kousei Hospital
        • Contact:
      • Osaka, Sakai, Japan, 590-0197
        • Not yet recruiting
        • Kindai University Hospital
        • Contact:
      • Saitama, Hidaka, Japan, 350-1298
        • Not yet recruiting
        • Saitama Medical University International Medical Center
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Not yet recruiting
        • Hamamatsu University Hospital
        • Contact:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Not yet recruiting
        • National Cancer Center Hospital
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
      • Wakayama, Wakayama, Japan, 641-8510
        • Not yet recruiting
        • Wakayama Medical University Hospital
        • Contact:
  • Latvia
      • Riga, Latvia, 1002
        • Not yet recruiting
        • Pauls Stradins Clinical University Hospital
        • Contact:
      • Riga, Latvia, 1079
        • Not yet recruiting
        • Riga East University Hospital
        • Contact:
  • Malaysia
      • George Town, Malaysia, 10450
        • Not yet recruiting
        • Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766
        • Contact:
      • Kota Kinabalu, Malaysia, 88996
        • Not yet recruiting
        • Hospital Wanita Dan Kanak-Kanak Sabah
        • Contact:
      • Kuching, Malaysia, 93586
        • Not yet recruiting
        • Sarawak General Hospital
        • Contact:
      • Putrajaya, Malaysia, 62250
        • Not yet recruiting
        • National Cancer Institute (IKN)
        • Contact:
      • Selangor Darul Ehsan, Malaysia, 47500
  • Mexico
      • Mexico City, Mexico, 03100
        • Not yet recruiting
        • Health Pharma Professional Research S.A. de C.V.
        • Contact:
      • Monterrey, Mexico, 66278
        • Not yet recruiting
        • Centro Medico Zambrano Hellion
        • Contact:
      • México, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional De Cancerologia
        • Contact:
      • México, Mexico, 06760
        • Not yet recruiting
        • Centro Oncologico Personalizado
        • Contact:
      • Nuevo León, Mexico, 64460
        • Not yet recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • Toluca, Mexico, 50180
        • Not yet recruiting
        • Centro Oncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"
        • Contact:
  • Moldova
      • Chisinau, Moldova, MD-2025
        • Not yet recruiting
        • ARENSIA Exploratory Medicine
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Not yet recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
        • Contact:
      • Maastricht, Netherlands, 6229 HX
        • Not yet recruiting
        • Maastricht University Medisch Centrum
        • Contact:
      • Rotterdam, Netherlands, 3015 GD
  • New Zealand
      • Auckland, New Zealand, 1023
      • Hamilton, New Zealand, 3204
  • Norway
      • Bergen, Norway, 5021
        • Not yet recruiting
        • Haukeland Universitetssykehus
        • Contact:
      • Oslo, Norway, N-0379
        • Not yet recruiting
        • Oslo Universitetssykehus HF, Radiumhospitalet
        • Contact:
      • Trondheim, Norway, 7030
        • Not yet recruiting
        • St. Olavs Hospital, Universitetssykehuset i Trondheim
        • Contact:
  • Poland
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • UCK Clinical Research Support Center
        • Contact:
      • Lodz, Poland, 93338
        • Not yet recruiting
        • Polish Mother's Memorial Hospital - Research Institute
        • Contact:
      • Lublin, Poland, 20090
        • Not yet recruiting
        • University Clinical Hospital No. 4 in Lublin
        • Contact:
      • Olsztyn, Poland, 10-357
        • Not yet recruiting
        • Warmia and Mazury Center for Lung Diseases in Olsztyn
        • Contact:
      • Wroclaw, Poland, 50-981
        • Not yet recruiting
        • 4. Military Clinical Hospital with Polyclinic SP ZOZ
        • Contact:
  • Portugal
      • Braga, Portugal, 4710-243
      • Coimbra, Portugal, 3004-561
        • Not yet recruiting
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1500-650
      • Porto, Portugal, 4100-180
      • Porto, Portugal, 4200-072
        • Not yet recruiting
        • IPO Porto Francisco Gentil, EPE
        • Contact:
  • Romania
      • Bucharest, Romania, 022328
        • Not yet recruiting
        • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
        • Contact:
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
        • Contact:
      • Craiova, Romania, 200542
        • Not yet recruiting
        • Centrul De Oncologie SF Nectarie S.R.L.
        • Contact:
  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 168583
        • Not yet recruiting
        • National Cancer Centre Singapore
        • Contact:
  • South Korea
      • Busan, South Korea, 49241
        • Not yet recruiting
        • Pusan National University Hospital
        • Contact:
      • Daejoen, South Korea, 35015
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
      • Goyang, South Korea, 10408
        • Not yet recruiting
        • National Cancer Center
        • Contact:
      • Hwasun, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Seongnam, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 08308
        • Not yet recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital
        • Contact:
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Samsung Medical Center
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08003
      • Girona, Spain, 17007
        • Not yet recruiting
        • Institut Català d'Oncologia de Girona.
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08908
        • Not yet recruiting
        • Hospital Duran i Reynals
        • Contact:
      • Las Palmas de Gran Canaria, Spain, 35016
        • Not yet recruiting
        • H. Universitario Insular de Canarias
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Puerta de Hierro
        • Contact:
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Fundación Jiménez Díaz
        • Contact:
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Regional Universitario de Malaga
        • Contact:
      • Palma de Mallorca, Spain, 07120
        • Not yet recruiting
        • Hospital Son Espases
        • Contact:
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra
        • Contact:
      • Seville, Spain, 41009
        • Not yet recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
      • Valencia, Spain, 46016
        • Not yet recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
  • Sweden
      • Gothenburg, Sweden, 413 46
        • Not yet recruiting
        • Sahlgrenska Universitetssjukhuset, Östra
        • Contact:
      • Gävle, Sweden, 801 87
      • Stockholm, Sweden, 171 76
        • Not yet recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
  • Switzerland
      • Baden, Switzerland, 5404
        • Not yet recruiting
        • Kantonsspital Baden AG
        • Contact:
      • Lausanne, Switzerland, 1011
        • Not yet recruiting
        • Centre Hospitalier Universitaire Vaudois
        • Contact:
      • Zurich, Switzerland, 8063
        • Not yet recruiting
        • Stadtspital Zürich
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Tainan, Taiwan, 70403
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 10048
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 106
        • Not yet recruiting
        • National Taiwan University Cancer Center
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10300
        • Not yet recruiting
        • Vajira Hospital
        • Contact:
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Siriraj Hospital
        • Contact:
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakom Chiangmai Hospital
        • Contact:
      • Hat Yai, Thailand, 90110
        • Not yet recruiting
        • Songklanagarind Hospital
        • Contact:
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Not yet recruiting
        • Adana Şehir Hastanesi
        • Contact:
      • Adana, Turkey (Türkiye)
        • Not yet recruiting
        • Medical Park Adana Hastanesi
        • Contact:
      • Ankara, Turkey (Türkiye), 06018
        • Not yet recruiting
        • Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
        • Contact:
      • Ankara, Turkey (Türkiye)
        • Not yet recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
        • Contact:
      • Atakum, Turkey (Türkiye)
        • Not yet recruiting
        • Samsun Medical Park Hastanesi
        • Contact:
      • Istanbul, Turkey (Türkiye), 34862
        • Not yet recruiting
        • Medeniyet University
        • Contact:
      • Istanbul, Turkey (Türkiye), 34890
        • Not yet recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
        • Contact:
      • Türkiye, Turkey (Türkiye)
        • Not yet recruiting
        • Ankara Bilkent Sehir Hastanesi
        • Contact:
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
      • Leicester, United Kingdom, LE1 5WW
      • Manchester, United Kingdom, M20 4BX
      • Sutton, United Kingdom, SM2 5PT
      • Torquay, United Kingdom, TQ2 7AA
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
    • Florida
      • Hialeah, Florida, United States, 33013
        • Not yet recruiting
        • Bioresearch Partner - Hialeah Hospital
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Monroe, Louisiana, United States, 71201
      • Shreveport, Louisiana, United States, 71105
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • University of Maryland School of Medicine
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Not yet recruiting
        • Veterans Affairs Ann Arbor Healthcare System
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64132
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • AHN Cancer Institute - Allegheny General
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Not yet recruiting
        • Hanoi Oncology Hospital
        • Contact:
      • Hanoi, Vietnam, 100000
        • Not yet recruiting
        • National Cancer Hospital, Hanoi
        • Contact:
      • Ho Chi Minh City, Vietnam, 70000
        • Not yet recruiting
        • University Medical Center HCMC
        • Contact:
      • Ho Chi Minh City, Vietnam, 70000
        • Not yet recruiting
        • Ho Chi Minh Oncology Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria :

  1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
  2. Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic 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 14 days prior to randomisation and 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 are 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 sites within 14 days prior to randomisation
  4. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and 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)
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm
Drug: carboplatin
carboplatin
Drug: etoposide
etoposide
Drug: obrixtamig
obrixtamig
Drug: atezolizumab
atezolizumab
Experimental: atezolizumab, carboplatin, and etoposide control arm
Drug: carboplatin
carboplatin
Drug: etoposide
etoposide
Drug: atezolizumab
atezolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 36 months
OS, defined as the time from randomisation until death from any cause
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Occurrence of treatment-emergent Cytokine Release Syndrome (CRS) during the on-treatment period
Time Frame: Up to 36 months
Up to 36 months
Occurrence of treatment-emergent Immune effector cell-associated neurotoxicity syndrome (ICANS) during the on-treatment period
Time Frame: Up to 36 months
Up to 36 months
Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation during the on-treatment period
Time Frame: Up to 36 months
Up to 36 months
Occurrence of treatment-emergent AEs leading to trial medication dose delay during the on-treatment period
Time Frame: Up to 36 months
Up to 36 months
Occurrence of treatment-emergent AEs leading to trial medication dose reduction during the on-treatment period
Time Frame: Up to 36 months
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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

September 9, 2028

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438-0012
  • 2025-520565-51-00 (Registry Identifier: CTIS)
  • U1111-1317-4955 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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