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
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
3 other identifiers
interventional
670
40 countries
216
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2026
Typical duration for phase_3
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2029
June 9, 2026
June 1, 2026
2.4 years
March 4, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS, defined as the time from randomisation until death from any cause
Up to 36 months
Secondary Outcomes (10)
Progression free survival (PFS)
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)
At baseline and up to 1 year
Overall response (OR)
Up to 36 months
Occurrence of treatment-emergent Cytokine Release Syndrome (CRS) during the on-treatment period
Up to 36 months
Occurrence of treatment-emergent Immune effector cell-associated neurotoxicity syndrome (ICANS) during the on-treatment period
Up to 36 months
- +5 more secondary outcomes
Study Arms (2)
obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm
EXPERIMENTALatezolizumab, carboplatin, and etoposide control arm
EXPERIMENTALInterventions
atezolizumab
carboplatin
etoposide
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- 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.
- 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 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
- 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
You may not qualify if:
- 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 sites within 14 days prior to randomisation
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (236)
Infirmary Cancer Care
Mobile, Alabama, 36607, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Bioresearch Partner - Hialeah Hospital
Hialeah, Florida, 33013, United States
Emory University
Atlanta, Georgia, 30322, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202, United States
Epic Medical Research - Monroe
Monroe, Louisiana, 71201, United States
Epic Medical Research - Shreveport
Shreveport, Louisiana, 71105, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
HCA MidAmerica Division, Inc.
Kansas City, Missouri, 64132, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
AHN Cancer Institute - Allegheny General
Pittsburgh, Pennsylvania, 15212, United States
Baptist Cancer Center - Memphis
Memphis, Tennessee, 38120, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Hospital Britanico de Buenos Aires
CABA, 1280AEB, Argentina
Clinica Adventista Belgrano
CABA, 1430, Argentina
Clinica Privada Independencia
Munro, B1605, Argentina
Sanatorio Allende S.A.
Nueva Córdoba, X5000JHQ, Argentina
Sanatorio Parque S.A.
Rosario, S2000DSV, Argentina
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, 2031, Australia
Ballarat Regional Integrated Cancer Centre
Ballarat, Victoria, 3350, Australia
Cancer Research South Australia
Adelaide, Australia
Hospital Elisabethinen Linz
Linz, 4020, Austria
Johannes Kepler University Linz
Linz, 4020, Austria
Standort Penzing der Klinik Ottakring
Vienna, 1160, Austria
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
UZ Leuven
Leuven, 3000, Belgium
Hospital de Amor
Barretos, 14784-400, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples
Porto Alegre, 90110-270, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS, CEP 90020-090, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500, Bulgaria
MHAT Heart and brain
Pleven, 5800, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Icegclinic
La Florida, 8240000, Chile
Clinica Santa Maria
Providencia, Chile
Instituto Oncológico FALP
Providencia, Chile
Bradford Hill- Centro de Investigación Clínica
Recoleta, 8420383, Chile
Clínica Alemana de Santiago S.A.
Santiago, 7650568, Chile
Beijing Cancer Hospital
Beijing, 100036, China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, China
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, 233004, China
Hunan Province Tumor Hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510060, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Linyi Cancer Hospital
Linyi, 276034, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330000, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Shanghai Chest Hospital
Shanghai, 200030, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Shanghai Geriatric Medical Center
Shanghai, 201104, China
Shanghai General Hospital
Shanghai, 210000, China
China Shenyang Chest Hospital
Shenyang, 110000, China
Shanxi Cancer hospital
Taiyuan, 030000, China
Tianjin Cancer Hospital
Tianjin, 300060, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Union Hospital
Wuhan, 430048, China
Xiangyang Central Hospital
Xiangyang, 441138, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221006, China
Northern Jiangsu People's Hospital
Yangzhou, 225001, China
Henan Cancer Hospital
Zhengzhou, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450015, China
University Hospital Olomouc
Olomouc, 77900, Czechia
University Thomayer´s Hospital
Prague, 140 59, Czechia
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
KYS Sädesairaala
Kuopio, 70029, Finland
Oulun yliopistollinen keskussairaala
Oulu, 90220, Finland
Turun Yliopistollinen sairaala
Turku, 20521, Finland
INS Bergonie
Bordeaux, 33000, France
CTR François Baclesse
Caen, 14076, France
CTR Georges-François Leclerc
Dijon, 21079, France
INS Paoli-Calmettes
Marseille, 13009, France
HOP Nord Laennec
Nantes, 44093, France
INS Curie
Paris, 75005, France
Hôpital Cochin
Paris, 75014, France
HOP Villefranche-sur-Saône
Villefranche-sur-Saône, 69400, France
Institut Gustave Roussy
Villejuif, 94800, France
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112, Georgia
Universitätsklinikum Aachen, AöR
Aachen, 52074, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Vivantes Klinikum Spandau
Berlin-Spandau, 13585, Germany
Technische Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 21075, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Westfälische Wilhelms-Universität Münster
Münster, 48149, Germany
Pius-Hospital, Oldenburg
Oldenburg, 26121, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078, Germany
Chest Hospital of Athens "Sotiria"
Athens, 115 27, Greece
Henry Dunant Hospital, Athens
Athens, 11526, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital-Hong Kong-20715
Shatin, 999077, Hong Kong
Koranyi National Institute For Pulmonolgy
Budapest, 1121, Hungary
University of Debrecen Clinical Centre
Debrecen, 4032, Hungary
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemét, 6000, Hungary
Tolna County Balassa Janos Hospital
Szekszárd, 7100, Hungary
Reformed Pulmonology Center
Törökbálint, 2045, Hungary
Cork University Hospital
Cork, T12 DFK4, Ireland
Centro di riferimento Oncologico
Aviano (PN), 33081, Italy
Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A. O. Universitaria Careggi
Florence, 50134, Italy
Istituto Scientifico Romagnolo
Meldola (FC), 47014, Italy
AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, 43100, Italy
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520, Japan
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914, Japan
Kindai University Hospital
Osaka, Sakai, 590-0197, Japan
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Riga East University Hospital
Riga, 1079, Latvia
Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766
George Town, 10450, Malaysia
Hospital Wanita Dan Kanak-Kanak Sabah
Kota Kinabalu, 88996, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
National Cancer Institute (IKN)
Putrajaya, 62250, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, 47500, Malaysia
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100, Mexico
Centro Oncologico Personalizado
México, 06760, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
Centro Medico Zambrano Hellion
Monterrey, 66278, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, 64460, Mexico
Centro Oncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"
Toluca, 50180, Mexico
ARENSIA Exploratory Medicine
Chisinau, MD-2025, Moldova
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX, Netherlands
Maastricht University Medisch Centrum
Maastricht, 6229 HX, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Haukeland Universitetssykehus
Bergen, 5021, Norway
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379, Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, 7030, Norway
UCK Clinical Research Support Center
Gdansk, 80-214, Poland
Polish Mother's Memorial Hospital - Research Institute
Lodz, 93338, Poland
University Clinical Hospital No. 4 in Lublin
Lublin, 20090, Poland
Warmia and Mazury Center for Lung Diseases in Olsztyn
Olsztyn, 10-357, Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, 50-981, Poland
ULS Braga
Braga, 4710-243, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3004-561, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Bucharest, 022328, Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Centrul De Oncologie SF Nectarie S.R.L.
Craiova, 200542, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
Chungnam National University Hospital
Daejoen, 35015, South Korea
National Cancer Center
Goyang, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Institut Català d'Oncologia de Girona.
Girona, 17007, Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908, Spain
H. Universitario Insular de Canarias
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Puerta de Hierro
Madrid, 28222, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46016, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Gävle sjukhus
Gävle, 801 87, Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 413 46, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Kantonsspital Baden AG
Baden, 5404, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Stadtspital Zürich
Zurich, 8063, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
National Taiwan University Cancer Center
Taipei, 106, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
Vajira Hospital
Bangkok, 10300, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakom Chiangmai Hospital
Chiang Mai, 50200, Thailand
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Adana Şehir Hastanesi
Adana, Turkey (Türkiye)
Medical Park Adana Hastanesi
Adana, Turkey (Türkiye)
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06018, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara, Turkey (Türkiye)
Samsun Medical Park Hastanesi
Atakum, Turkey (Türkiye)
Medeniyet University
Istanbul, 34862, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Türkiye, Turkey (Türkiye)
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
Hanoi Oncology Hospital
Hanoi, 100000, Vietnam
National Cancer Hospital, Hanoi
Hanoi, 100000, Vietnam
Ho Chi Minh Oncology Hospital
Ho Chi Minh City, 70000, Vietnam
University Medical Center HCMC
Ho Chi Minh City, 70000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 16, 2026
Study Start
April 13, 2026
Primary Completion (Estimated)
September 9, 2028
Study Completion (Estimated)
July 30, 2029
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.