Small Cell Lung Cancer (SCLC)Phase 3NCT07472517
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
A Phase 3 study testing obrixtamig, atezolizumab and carboplatin in people with Small Cell Lung Cancer (SCLC) and Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Boehringer Ingelheim at 245 sites in 42 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- obrixtamig, atezolizumab and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 245 sitesin 42 countries
- Study dates
- 13 Apr 2026to 30 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- 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.
- 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.
- 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
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- 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
- 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.
Who cannot join
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- Radiotherapy of any anatomical site within 7 days prior to randomisation
- 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
- 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.
Trial locations and contacts
245 sites in 42 countries. Contact the study team or a site near you to ask about taking part.
245 sites in 42 countries
China33 sites, 33 recruiting
- Not yet recruiting
Beijing Cancer Hospital
Beijing, 100036
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, 233004
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Hunan Province Tumor Hospital
Changsha, 410013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, 350014
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Linyi Cancer Hospital
Linyi, 276034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Geriatric Medical Center
Shanghai, 201104
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai General Hospital
Shanghai, 210000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
China Shenyang Chest Hospital
Shenyang, 110000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Shanxi Cancer hospital
Taiyuan, 030000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430048
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, 441138
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, 225001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, 450003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450015
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
United States17 sites, 17 recruiting
- Not yet recruiting
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Emory University
Atlanta, Georgia, 30322
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Cape Fear Valley Cancer Center
Fayetteville, North Carolina, 28303
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Bioresearch Partner - Hialeah Hospital
Hialeah, Florida, 33013
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
HCA MidAmerica Division, Inc.
Kansas City, Missouri, 64132
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Baptist Cancer Center - Memphis
Memphis, Tennessee, 38120
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Infirmary Cancer Care
Mobile, Alabama, 36607
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Epic Medical Research - Monroe
Monroe, Louisiana, 71201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Ochsner Medical Center
New Orleans, Louisiana, 70121
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Pikeville Medical Center
Pikeville, Kentucky, 41501
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
AHN Cancer Institute - Allegheny General
Pittsburgh, Pennsylvania, 15212
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Epic Medical Research - Shreveport
Shreveport, Louisiana, 71105
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Spain17 sites, 17 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Institut Català d'Oncologia de Girona.
Girona, 17007
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
H. Universitario Insular de Canarias
Las Palmas de Gran Canaria, 35016
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Fundación Jiménez Díaz
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Puerta de Hierro
Madrid, 28222
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Son Espases
Palma de Mallorca, 07120
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen De La Macarena
Seville, 41009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46016
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Germany15 sites, 15 recruiting
- Recruiting
Universitätsklinikum Aachen, AöR
Aachen, 52074
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Vivantes Klinikum Spandau
Berlin-Spandau, 13585
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Technische Universität Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Essen AöR
Essen, 45147
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60590
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 21075
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Westfälische Wilhelms-Universität Münster
Münster, 48149
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Pius-Hospital, Oldenburg
Oldenburg, 26121
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan12 sites, 12 recruiting
- Recruiting
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kindai University Hospital
Osaka, Sakai, 590-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
France10 sites, 10 recruiting
- Not yet recruiting
INS Cancérologie de l'Ouest
Angers, 49055
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Bergonie
Bordeaux, 33000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
CTR François Baclesse
Caen, 14076
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
CTR Georges-François Leclerc
Dijon, 21079
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Nord Laennec
Nantes, 44093
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Curie
Paris, 75005
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hôpital Cochin
Paris, 75014
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Villefranche-sur-Saône
Villefranche-sur-Saône, 69400
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Italy10 sites, 10 recruiting
- Not yet recruiting
Centro di riferimento Oncologico
Aviano (PN), 33081
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Istituto Tumori Giovanni Paolo II
Bari, 70124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
A. O. Universitaria Careggi
Florence, 50134
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Scientifico Romagnolo
Meldola (FC), 47014
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
AOU San Luigi Gonzaga
Orbassano (TO), 10043
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Azienda Ospedaliera Unversitaria di Parma
Parma, 43100
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
South Korea10 sites, 10 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Chungnam National University Hospital
Daejoen, 35015
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
National Cancer Center
Goyang, 10408
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Turkey (Türkiye)10 sites, 10 recruiting
- Not yet recruiting
Adana Şehir Hastanesi
Adana
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Medical Park Adana Hastanesi
Adana
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06018
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Ankara Liv Hastanesi
Ankara
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Samsun Medical Park Hastanesi
Atakum
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Medeniyet University
Istanbul, 34862
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Ege Üniversitesi Tıp Fakültesi
Izmir
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Ankara Bilkent Sehir Hastanesi
Türkiye
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
Mexico7 sites, 7 recruiting
- Not yet recruiting
Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente
Guadalajara, Jalisco, 44329
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Oncologico Personalizado
México, 06760
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Instituto Nacional de Cancerologia
México, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Medico Zambrano Hellion
Monterrey, 66278
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, 64460
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Oncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"
Toluca, 50180
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Taiwan7 sites, 7 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Taiwan University Hospital
Taipei, 10048
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Not yet recruiting
National Taiwan University Cancer Center
Taipei, 106
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Hungary6 sites, 6 recruiting
- Not yet recruiting
Koranyi National Institute For Pulmonolgy
Budapest, 1121
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Not yet recruiting
University of Debrecen Clinical Centre
Debrecen, 4032
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Not yet recruiting
Bekes County Central Hospital
Gyula, 5700
- Not yet recruiting
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemét, 6000
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Not yet recruiting
Tolna County Balassa Janos Hospital
Szekszárd, 7100
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Not yet recruiting
Reformed Pulmonology Center
Törökbálint, 2045
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Argentina5 sites, 5 recruiting
- Recruiting
Hospital Britanico de Buenos Aires
CABA, 1280AEB
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Adventista Belgrano
CABA, 1430
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Privada Independencia
Munro, B1605
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Allende S.A.
Nueva Córdoba, X5000JHQ
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Parque S.A.
Rosario, S2000DSV
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Chile5 sites, 5 recruiting
- Recruiting
Icegclinic
La Florida, 8240000
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Recruiting
Clinica Santa Maria
Providencia
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Not yet recruiting
Instituto Oncologico FALP
Providencia
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Not yet recruiting
Bradford Hill- Centro de Investigacion Clinica
Recoleta, 8420383
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Not yet recruiting
Clinica Alemana de Santiago S.A.
Santiago, 7650568
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
Malaysia5 sites, 5 recruiting
- Recruiting
Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766
George Town, 10450
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Wanita Dan Kanak-Kanak Sabah
Kota Kinabalu, 88996
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Sarawak General Hospital
Kuching, 93586
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
National Cancer Institute (IKN)
Putrajaya, 62250
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Sunway Medical Centre
Selangor Darul Ehsan, 47500
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
Portugal5 sites, 5 recruiting
- Recruiting
ULS de Braga, E.P.E
Braga, 4710-243
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Hospital da Luz
Lisbon, 1500-650
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Hospital CUF Porto
Porto, 4100-180
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
IPO Porto Francisco Gentil, EPE
Porto, 4200-072
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Belgium4 sites, 4 recruiting
- Not yet recruiting
Centre Hospitalier Interrégional Edith Cavell (CHIREC)
Brussels, 1160
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Brazil4 sites, 4 recruiting
- Recruiting
Hospital de Amor
Barretos, 14784-400
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples
Porto Alegre, 90110-270
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS, CEP 90020-090
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Poland4 sites, 4 recruiting
- Not yet recruiting
UCK Clinical Research Support Center
Gdansk, 80-214
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Polish Mother's Memorial Hospital - Research Institute
Lodz, 93338
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
University Clinical Hospital No. 4 in Lublin
Lublin, 20090
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Warmia and Mazury Center for Lung Diseases in Olsztyn
Olsztyn, 10-357
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Thailand4 sites, 4 recruiting
- Recruiting
Vajira Hospital
Bangkok, 10300
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Siriraj Hospital
Bangkok, 10700
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Maharaj Nakom Chiangmai Hospital
Chiang Mai, 50200
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Songklanagarind Hospital
Hat Yai, 90110
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Vietnam4 sites, 4 recruiting
- Not yet recruiting
Hanoi Oncology Hospital
Hanoi, 100000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Vietnam National Cancer Hospital
Hanoi, 100000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
Ho Chi Minh Oncology Hospital
Ho Chi Minh City, 70000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
- Not yet recruiting
University Medical Center HCMC
Ho Chi Minh City, 70000
Boehringer Ingelheim, 01800545473, vietnam@bitrialsupport.com
Australia3 sites, 3 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, 5000
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Ballarat Regional Integrated Cancer Centre
Ballarat, Victoria, 3350
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, 2031
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Austria3 sites, 3 recruiting
- Recruiting
Hospital Elisabethinen Linz
Linz, 4020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Not yet recruiting
Johannes Kepler University Linz
Linz, 4020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Not yet recruiting
Standort Penzing der Klinik Ottakring
Vienna, 1160
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Bulgaria3 sites, 3 recruiting
- Not yet recruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Not yet recruiting
MHAT Heart and brain
Pleven, 5800
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Not yet recruiting
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, 1407
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Finland3 sites, 3 recruiting
- Recruiting
KYS Sädesairaala
Kuopio, 70029
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Recruiting
Oulun yliopistollinen keskussairaala
Oulu, 90220
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Not yet recruiting
Turun Yliopistollinen sairaala
Turku, 20521
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Greece3 sites, 3 recruiting
- Not yet recruiting
Chest Hospital of Athens "Sotiria"
Athens, 115 27
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
Henry Dunant Hospital, Athens
Athens, 11526
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Recruiting
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Netherlands3 sites, 3 recruiting
- Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Recruiting
Maastricht University Medisch Centrum
Maastricht, 6229 HX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Norway3 sites, 3 recruiting
- Recruiting
Haukeland Universitetssykehus
Bergen, 5021
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, 7030
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Romania3 sites, 3 recruiting
- Recruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Bucharest, 022328
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
Centrul De Oncologie SF Nectarie S.R.L.
Craiova, 200542
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Sweden3 sites, 3 recruiting
- Recruiting
Gävle sjukhus
Gävle, 801 87
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 413 46
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Canada2 sites, 2 recruiting
- Not yet recruiting
Verspeeten Family Cancer Centre (LHSC)
London, Ontario, N6A 5W9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Czechia2 sites, 2 recruiting
- Not yet recruiting
University Hospital Olomouc
Olomouc, 77900
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
- Not yet recruiting
University Thomayer´s Hospital
Prague, 140 59
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Estonia2 sites, 2 recruiting
- Not yet recruiting
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419
Boehringer Ingelheim, 8000044842, eesti@bitrialsupport.com
- Not yet recruiting
Tartu University Hospital
Tartu, 50406
Boehringer Ingelheim, 8000044842, eesti@bitrialsupport.com
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
- Recruiting
Prince of Wales Hospital-Hong Kong-20715
Shatin, 999077
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
Latvia2 sites, 2 recruiting
- Not yet recruiting
Pauls Stradins Clinical University Hospital
Riga, 1002
Boehringer Ingelheim, 80200224, latvia@bitrialsupport.com
- Not yet recruiting
Rigas Austrumu kliniska universitates slimnica SIA
Riga, 1079
Boehringer Ingelheim, 80200224, latvia@bitrialsupport.com
New Zealand2 sites, 2 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
- Recruiting
Waikato Hospital
Hamilton, 3204
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Kantonsspital Baden AG
Baden, 5404
Boehringer Ingelheim, 0800005900, suisse@bitrialsupport.com
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Boehringer Ingelheim, 0800005900, suisse@bitrialsupport.com
Georgia1 site, 1 recruiting
- Recruiting
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112
Boehringer Ingelheim, 800008086, sakartvelo@bitrialsupport.com
Ireland1 site, 1 recruiting
- Not yet recruiting
Cork University Hospital
Cork, T12 DFK4
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Moldova1 site, 1 recruiting
- Recruiting
ARENSIA Exploratory Medicine
Chisinau, MD-2025
Boehringer Ingelheim, 80060024, moldova@bitrialsupport.com
About this study
Official title: 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.
- Being tested
- obrixtamig, atezolizumab, carboplatin, etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obrixtamigDrug
obrixtamig
atezolizumabDrug
atezolizumab
carboplatinDrug
carboplatin
etoposideDrug
etoposide
| Study group | Role | What they receive |
|---|---|---|
| obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm | Experimental | Not described Receives: Drug: obrixtamig; Drug: atezolizumab; Drug: carboplatin; Drug: etoposide |
| atezolizumab, carboplatin, and etoposide control arm | Experimental | Not described Receives: Drug: atezolizumab; Drug: carboplatin; Drug: etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS, defined as the time from randomisation until death from any cause
Measured: Up to 36 months
Secondary outcomes (10)
Progression free survival (PFS)
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
Measured: 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)
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
Measured: At baseline and up to 1 year
Overall response (OR)
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
Measured: Up to 36 months
Occurrence of treatment-emergent Cytokine Release Syndrome (CRS) during the on-treatment period
Measured: Up to 36 months
Occurrence of treatment-emergent Immune effector cell-associated neurotoxicity syndrome (ICANS) during the on-treatment period
Measured: Up to 36 months
Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation during the on-treatment period
Measured: Up to 36 months
Occurrence of treatment-emergent AEs leading to trial medication dose delay during the on-treatment period
Measured: Up to 36 months
Occurrence of treatment-emergent AEs leading to trial medication dose reduction during the on-treatment period
Measured: 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
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.
Measured: 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
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
Measured: At baseline and up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start13 Apr 2026
- Primary completion9 Sep 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472517
- Sponsor's protocol ID
- 1438-0012
- Other IDs
- 2025-520565-51-00, U1111-1317-4955, 2025
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07472517
- Acronym / sponsor ID
- 1438-0012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 9 Sep 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm | Experimental | Drug: obrixtamig, Drug: atezolizumab, Drug: carboplatin, Drug: etoposide |
| atezolizumab, carboplatin, and etoposide control arm | Experimental | Drug: atezolizumab, Drug: carboplatin, Drug: etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- 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.
- 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.
- Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Key exclusion criteria (6 listed)
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- Radiotherapy of any anatomical site within 7 days prior to randomisation
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obrixtamigobrixtamig | Drug | obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm |
| atezolizumabatezolizumab | Drug | atezolizumab, carboplatin, and etoposide control arm, obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm |
| carboplatincarboplatin | Drug | atezolizumab, carboplatin, and etoposide control arm, obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm |
| etoposideetoposide | Drug | atezolizumab, carboplatin, and etoposide control arm, obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm |
Primary outcome
Overall survival (OS)
Time frame: Up to 36 months
OS, defined as the time from randomisation until death from any cause
10 secondary outcomes
Progression free survival (PFS)
Time frame: 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
Overall response (OR)
Time frame: Up to 36 months
Occurrence of treatment-emergent Cytokine Release Syndrome (CRS) during the on-treatment period
Time frame: 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
Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation during the on-treatment period
Time frame: 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
Occurrence of treatment-emergent AEs leading to trial medication dose reduction during the on-treatment period
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
245 sites in 42 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing obrixtamig, atezolizumab and carboplatin in people with Small Cell Lung Cancer (SCLC) and Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Boehringer Ingelheim at 245 sites in 42 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 245 sites in China, United States, Spain, Germany, Japan and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.