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Recruiting Phase 3 NCT07472517

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

Phase 3 – large-scale trial before approval
Conditions: Small Cell Lung Cancer (SCLC) Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Sponsor: Boehringer Ingelheim

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
obrixtamig
DRUG
atezolizumab
DRUG
carboplatin
DRUG
etoposide
DRUG
Locations 232
Argentina (5)
Hospital Britanico de Buenos Aires
CABA
NOT_YET_RECRUITING
Clinica Adventista Belgrano
CABA
NOT_YET_RECRUITING
Clinica Privada Independencia
Munro
NOT_YET_RECRUITING
Sanatorio Allende S.A.
Nueva Córdoba
NOT_YET_RECRUITING
Sanatorio Parque S.A.
Rosario
NOT_YET_RECRUITING
Australia (3)
Cancer Research South Australia
Adelaide
NOT_YET_RECRUITING
Ballarat Regional Integrated Cancer Centre
Ballarat , Victoria
NOT_YET_RECRUITING
Prince of Wales Hospital-Randwick-66496
Randwick , New South Wales
NOT_YET_RECRUITING
Austria (3)
Hospital Elisabethinen Linz
Linz
NOT_YET_RECRUITING
Johannes Kepler University Linz
Linz
NOT_YET_RECRUITING
Standort Penzing der Klinik Ottakring
Vienna
NOT_YET_RECRUITING
Belgium (3)
Edegem - UNIV UZ Antwerpen
Edegem
NOT_YET_RECRUITING
Universitair Ziekenhuis Brussel
Jette
NOT_YET_RECRUITING
UZ Leuven
Leuven
NOT_YET_RECRUITING
Brazil (3)
Hospital de Amor
Barretos
NOT_YET_RECRUITING
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS
NOT_YET_RECRUITING
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
NOT_YET_RECRUITING
Bulgaria (3)
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte
NOT_YET_RECRUITING
MHAT Heart and brain
Pleven
NOT_YET_RECRUITING
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia
NOT_YET_RECRUITING
Canada (1)
Sault Area Hospital
Sault Ste. Marie , Ontario
NOT_YET_RECRUITING
Chile (5)
Icegclinic
La Florida
NOT_YET_RECRUITING
Clinica Santa Maria
Providencia
NOT_YET_RECRUITING
Instituto Oncológico FALP
Providencia
NOT_YET_RECRUITING
Bradford Hill- Centro de Investigación Clínica
Recoleta
NOT_YET_RECRUITING
Clínica Alemana de Santiago S.A.
Santiago
NOT_YET_RECRUITING
China (33)
Beijing Cancer Hospital
Beijing
NOT_YET_RECRUITING
Beijing Chest Hospital, Capital Medical University
Beijing
NOT_YET_RECRUITING
The First Affiliated Hospital Of Bengbu Medical College
Bengbu
NOT_YET_RECRUITING
Hunan Province Tumor Hospital
Changsha
NOT_YET_RECRUITING
Sichuan Cancer Hospital
Chengdu
NOT_YET_RECRUITING
West China Hospital, Sichuan University
Chengdu
NOT_YET_RECRUITING
Fujian Cancer Hospital
Fuzhou
NOT_YET_RECRUITING
Sun Yat-Sen University Cancer Center
Guangzhou
NOT_YET_RECRUITING
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou
NOT_YET_RECRUITING
The First Affiliated Hospital, Zhejiang University
Hangzhou
NOT_YET_RECRUITING
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou
NOT_YET_RECRUITING
Harbin Medical University Cancer Hospital
Harbin
NOT_YET_RECRUITING
Shandong Cancer Hospital
Jinan
NOT_YET_RECRUITING
Linyi Cancer Hospital
Linyi
NOT_YET_RECRUITING
The First Affiliated Hospital of Nanchang University
Nanchang
NOT_YET_RECRUITING
The Second Affiliated Hospital to Nanchang University
Nanchang
NOT_YET_RECRUITING
Nanjing Drum Tower Hospital
Nanjing
NOT_YET_RECRUITING
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning
NOT_YET_RECRUITING
The First Affiliated Hospital of Ningbo University
Ningbo
NOT_YET_RECRUITING
Shanghai Chest Hospital
Shanghai
NOT_YET_RECRUITING
Shanghai Pulmonary Hospital
Shanghai
NOT_YET_RECRUITING
Shanghai Geriatric Medical Center
Shanghai
NOT_YET_RECRUITING
Shanghai General Hospital
Shanghai
NOT_YET_RECRUITING
China Shenyang Chest Hospital
Shenyang
NOT_YET_RECRUITING
Shanxi Cancer hospital
Taiyuan
NOT_YET_RECRUITING
Tianjin Cancer Hospital
Tianjin
NOT_YET_RECRUITING
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
NOT_YET_RECRUITING
Wuhan Union Hospital
Wuhan
NOT_YET_RECRUITING
Xiangyang Central Hospital
Xiangyang
NOT_YET_RECRUITING
Affiliated Hospital, Xuzhou Medical college
Xuzhou
NOT_YET_RECRUITING
Northern Jiangsu People's Hospital
Yangzhou
NOT_YET_RECRUITING
Henan Cancer Hospital
Zhengzhou
NOT_YET_RECRUITING
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
NOT_YET_RECRUITING
Czech Republic (2)
University Hospital Olomouc
Olomouc
NOT_YET_RECRUITING
University Thomayer´s Hospital
Prague
NOT_YET_RECRUITING
Estonia (2)
North Estonia Medical Centre Foundation, Tallinn
Tallinn
NOT_YET_RECRUITING
Tartu University Hospital
Tartu
NOT_YET_RECRUITING
Finland (3)
KYS Sädesairaala
Kuopio
NOT_YET_RECRUITING
Oulun yliopistollinen keskussairaala
Oulu
NOT_YET_RECRUITING
Turun Yliopistollinen sairaala
Turku
NOT_YET_RECRUITING
France (10)
INS Bergonie
Bordeaux
NOT_YET_RECRUITING
CTR François Baclesse
Caen
NOT_YET_RECRUITING
CTR Georges-François Leclerc
Dijon
NOT_YET_RECRUITING
INS Paoli-Calmettes
Marseille
NOT_YET_RECRUITING
HOP Nord Laennec
Nantes
NOT_YET_RECRUITING
INS Curie
Paris
NOT_YET_RECRUITING
Hôpital Cochin
Paris
NOT_YET_RECRUITING
INS Cancérologie de l'Ouest
Saint-Herblain
NOT_YET_RECRUITING
HOP Villefranche-sur-Saône
Villefranche-sur-Saône
NOT_YET_RECRUITING
Institut Gustave Roussy
Villejuif
NOT_YET_RECRUITING
Georgia (1)
ARENSIA Exploratory Medicine LLC
Tbilisi
NOT_YET_RECRUITING
Germany (14)
Universitätsklinikum Aachen, AöR
Aachen
NOT_YET_RECRUITING
Charité - Universitätsmedizin Berlin
Berlin
NOT_YET_RECRUITING
Vivantes Klinikum Spandau
Berlin-Spandau
NOT_YET_RECRUITING
Technische Universität Dresden
Dresden
NOT_YET_RECRUITING
Universitätsklinikum Frankfurt
Frankfurt
NOT_YET_RECRUITING
Universitätsklinikum Freiburg
Freiburg im Breisgau
NOT_YET_RECRUITING
Asklepios Fachkliniken München-Gauting
Gauting
NOT_YET_RECRUITING
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen
NOT_YET_RECRUITING
LungenClinic Grosshansdorf GmbH
Großhansdorf
NOT_YET_RECRUITING
Asklepios Kliniken GmbH & Co. KGaA
Hamburg
NOT_YET_RECRUITING
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg
NOT_YET_RECRUITING
Westfälische Wilhelms-Universität Münster
Münster
NOT_YET_RECRUITING
Pius-Hospital, Oldenburg
Oldenburg
NOT_YET_RECRUITING
Universitätsklinikum Würzburg AÖR
Würzburg
NOT_YET_RECRUITING
Greece (3)
Chest Hospital of Athens "Sotiria"
Athens
NOT_YET_RECRUITING
Henry Dunant Hospital, Athens
Athens
NOT_YET_RECRUITING
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki
NOT_YET_RECRUITING
Hong Kong (2)
Queen Mary Hospital
Hong Kong
NOT_YET_RECRUITING
Prince of Wales Hospital-Hong Kong-20715
Shatin
NOT_YET_RECRUITING
Hungary (5)
Koranyi National Institute For Pulmonolgy
Budapest
NOT_YET_RECRUITING
University of Debrecen Clinical Centre
Debrecen
NOT_YET_RECRUITING
Bacs-Kiskun Megyei Onkormanyzat Hospital
Kecskemét
NOT_YET_RECRUITING
Tolna County Balassa Janos Hospital
Szekszárd
NOT_YET_RECRUITING
Reformed Pulmonology Center
Törökbálint
NOT_YET_RECRUITING
Ireland (1)
Cork University Hospital
Cork
NOT_YET_RECRUITING
Italy (10)
Centro di riferimento Oncologico
Aviano (PN)
NOT_YET_RECRUITING
Istituto Tumori Giovanni Paolo II
Bari
NOT_YET_RECRUITING
ASST degli Spedali Civili di Brescia
Brescia
NOT_YET_RECRUITING
A. O. Universitaria Careggi
Florence
NOT_YET_RECRUITING
Istituto Scientifico Romagnolo
Meldola (FC)
NOT_YET_RECRUITING
AOU San Luigi Gonzaga
Orbassano (TO)
NOT_YET_RECRUITING
Istituto Oncologico Veneto IRCCS
Padova
NOT_YET_RECRUITING
Azienda Ospedaliera Unversitaria di Parma
Parma
NOT_YET_RECRUITING
Fondazione Policlinico Universitario Campus Bio-medico
Roma
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Integrata Verona
Verona
NOT_YET_RECRUITING
Japan (12)
Fujita Health University Hospital
Aichi, Toyoake
NOT_YET_RECRUITING
Hirosaki University Hospital
Aomori, Hirosaki
NOT_YET_RECRUITING
Kyushu University Hospital
Fukuoka, Fukuoka
NOT_YET_RECRUITING
Hokkaido University Hospital
Hokkaido, Sapporo
NOT_YET_RECRUITING
Kagoshima University Hospital
Kagoshima, Kagoshima
NOT_YET_RECRUITING
Sendai Kousei Hospital
Miyagi, Sendai
NOT_YET_RECRUITING
Kindai University Hospital
Osaka, Sakai
NOT_YET_RECRUITING
Saitama Medical University International Medical Center
Saitama, Hidaka
NOT_YET_RECRUITING
Hamamatsu University Hospital
Shizuoka, Hamamatsu
NOT_YET_RECRUITING
National Cancer Center Hospital
Tokyo, Chuo-ku
NOT_YET_RECRUITING
Japanese Foundation for Cancer Research
Tokyo, Koto-ku
Wakayama Medical University Hospital
Wakayama, Wakayama
NOT_YET_RECRUITING
Latvia (2)
Pauls Stradins Clinical University Hospital
Riga
NOT_YET_RECRUITING
Riga East University Hospital
Riga
NOT_YET_RECRUITING
Malaysia (5)
Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766
George Town
NOT_YET_RECRUITING
Hospital Wanita Dan Kanak-Kanak Sabah
Kota Kinabalu
NOT_YET_RECRUITING
Sarawak General Hospital
Kuching
NOT_YET_RECRUITING
National Cancer Institute (IKN)
Putrajaya
NOT_YET_RECRUITING
Sunway Medical Centre
Selangor Darul Ehsan
NOT_YET_RECRUITING
Mexico (4)
Instituto Nacional de Cancerologia
México
NOT_YET_RECRUITING
Health Pharma Professional Research S.A. de C.V.
Mexico City
NOT_YET_RECRUITING
Centro Medico Zambrano Hellion
Monterrey
NOT_YET_RECRUITING
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León
NOT_YET_RECRUITING
Moldova (1)
ARENSIA Exploratory Medicine
Chisinau
NOT_YET_RECRUITING
Netherlands (3)
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam
NOT_YET_RECRUITING
Maastricht University Medisch Centrum
Maastricht
NOT_YET_RECRUITING
Erasmus Medisch Centrum
Rotterdam
NOT_YET_RECRUITING
New Zealand (2)
Auckland City Hospital
Auckland
NOT_YET_RECRUITING
Waikato Hospital
Hamilton
NOT_YET_RECRUITING
Norway (3)
Haukeland Universitetssykehus
Bergen
NOT_YET_RECRUITING
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo
NOT_YET_RECRUITING
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim
NOT_YET_RECRUITING
Poland (5)
UCK Clinical Research Support Center
Gdansk
NOT_YET_RECRUITING
Polish Mother's Memorial Hospital - Research Institute
Lodz
NOT_YET_RECRUITING
University Clinical Hospital No. 4 in Lublin
Lublin
NOT_YET_RECRUITING
Warmia and Mazury Center for Lung Diseases in Olsztyn
Olsztyn
NOT_YET_RECRUITING
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw
NOT_YET_RECRUITING
Portugal (5)
ULS Braga
Braga
NOT_YET_RECRUITING
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra
NOT_YET_RECRUITING
Hospital da Luz
Lisbon
NOT_YET_RECRUITING
Hospital CUF Porto
Porto
NOT_YET_RECRUITING
IPO Porto Francisco Gentil, EPE
Porto
NOT_YET_RECRUITING
Romania (3)
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Bucharest
NOT_YET_RECRUITING
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca
NOT_YET_RECRUITING
Centrul De Oncologie SF Nectarie S.R.L.
Craiova
NOT_YET_RECRUITING
Singapore (2)
National Cancer Centre Singapore
Singapore
NOT_YET_RECRUITING
Tan Tock Seng Hospital
Singapore
NOT_YET_RECRUITING
South Africa (1)
Rainbow Oncology
KwaZulu
NOT_YET_RECRUITING
South Korea (10)
Pusan National University Hospital
Busan
NOT_YET_RECRUITING
Chungnam National University Hospital
Daejoen
NOT_YET_RECRUITING
National Cancer Center
Goyang
NOT_YET_RECRUITING
Chonnam National University Hwasun Hospital
Hwasun
NOT_YET_RECRUITING
Seoul National University Bundang Hospital
Seongnam
NOT_YET_RECRUITING
Seoul National University Hospital
Seoul
NOT_YET_RECRUITING
Severance Hospital
Seoul
NOT_YET_RECRUITING
Asan Medical Center
Seoul
NOT_YET_RECRUITING
Samsung Medical Center
Seoul
NOT_YET_RECRUITING
Korea University Guro Hospital
Seoul
NOT_YET_RECRUITING
Spain (17)
Complejo Hospitalario Universitario A Coruña
A Coruña
NOT_YET_RECRUITING
Hospital del Mar
Barcelona
NOT_YET_RECRUITING
Hospital Universitari Vall d'Hebron
Barcelona
NOT_YET_RECRUITING
Hospital de Canarias
Canarias
NOT_YET_RECRUITING
Institut Català d'Oncologia de Girona.
Girona
NOT_YET_RECRUITING
Hospital Duran i Reynals
L'Hospitalet de Llobregat
NOT_YET_RECRUITING
Hospital Universitario Ramon Y Cajal
Madrid
NOT_YET_RECRUITING
Fundación Jiménez Díaz
Madrid
NOT_YET_RECRUITING
Hospital Universitario 12 de Octubre
Madrid
NOT_YET_RECRUITING
Hospital Puerta de Hierro
Madrid
NOT_YET_RECRUITING
Hospital Regional Universitario de Málaga
Málaga
NOT_YET_RECRUITING
Hospital Son Espases
Palma de Mallorca
NOT_YET_RECRUITING
Clínica Universidad de Navarra
Pamplona
NOT_YET_RECRUITING
Hospital Universitario Virgen De La Macarena
Seville
NOT_YET_RECRUITING
Hospital Clinico Universitario de Valencia
Valencia
NOT_YET_RECRUITING
Hospital Universitari i Politècnic La Fe
Valencia
NOT_YET_RECRUITING
Hospital Clinico Universitario Lozano Blesa
Zaragoza
NOT_YET_RECRUITING
Sweden (3)
Gävle sjukhus
Gävle
NOT_YET_RECRUITING
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg
NOT_YET_RECRUITING
Karolinska Universitetssjukhuset Solna
Stockholm
NOT_YET_RECRUITING
Switzerland (3)
Kantonsspital Baden AG
Baden
NOT_YET_RECRUITING
Centre Hospitalier Universitaire Vaudois
Lausanne
NOT_YET_RECRUITING
Stadtspital Zürich
Zurich
NOT_YET_RECRUITING
Taiwan (6)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
NOT_YET_RECRUITING
Taichung Veterans General Hospital
Taichung
NOT_YET_RECRUITING
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
Chang Gung Memorial Hospital, Linkou
Taoyuan
NOT_YET_RECRUITING
Thailand (4)
Vajira Hospital
Bangkok
NOT_YET_RECRUITING
Siriraj Hospital
Bangkok
NOT_YET_RECRUITING
Maharaj Nakom Chiangmai Hospital
Chiang Mai
NOT_YET_RECRUITING
Songklanagarind Hospital
Hat Yai
NOT_YET_RECRUITING
Turkey (8)
Adana Şehir Hastanesi
Adana
NOT_YET_RECRUITING
Medical Park Adana Hastanesi
Adana
NOT_YET_RECRUITING
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara
NOT_YET_RECRUITING
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara
NOT_YET_RECRUITING
Samsun Medical Park Hastanesi
Atakum
NOT_YET_RECRUITING
Medeniyet University
Istanbul
NOT_YET_RECRUITING
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul
NOT_YET_RECRUITING
Ankara Bilkent Sehir Hastanesi
Türkiye
NOT_YET_RECRUITING
United Kingdom (5)
Velindre Cancer Centre
Cardiff
NOT_YET_RECRUITING
Leicester Royal Infirmary
Leicester
NOT_YET_RECRUITING
The Christie Hospital
Manchester
NOT_YET_RECRUITING
The Royal Marsden Hospital, Sutton
Sutton
NOT_YET_RECRUITING
Torbay Hospital
Torquay
NOT_YET_RECRUITING
United States (12)
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor , Michigan
NOT_YET_RECRUITING
Emory University
Atlanta , Georgia
NOT_YET_RECRUITING
University of Maryland School of Medicine
Baltimore , Maryland
NOT_YET_RECRUITING
Cleveland Clinic
Cleveland , Ohio
NOT_YET_RECRUITING
Bioresearch Partner - Hialeah Hospital
Hialeah , Florida
NOT_YET_RECRUITING
University of Arkansas for Medical Sciences
Little Rock , Arkansas
NOT_YET_RECRUITING
Norton Cancer Institute, Downtown
Louisville , Kentucky
NOT_YET_RECRUITING
University of Wisconsin
Madison , Wisconsin
NOT_YET_RECRUITING
Baptist Cancer Center - Memphis
Memphis , Tennessee
NOT_YET_RECRUITING
Infirmary Cancer Care
Mobile , Alabama
NOT_YET_RECRUITING
University of Nebraska Medical Center
Omaha , Nebraska
NOT_YET_RECRUITING
AHN Cancer Institute - Allegheny General
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Vietnam (4)
Hanoi Oncology Hospital
Hanoi
NOT_YET_RECRUITING
National Cancer Hospital, Hanoi
Hanoi
NOT_YET_RECRUITING
Ho Chi Minh Oncology Hospital
Ho Chi Minh City
NOT_YET_RECRUITING
University Medical Center HCMC
Ho Chi Minh City
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.04.2026
Completion date
30.07.2029
Registry ID
NCT07472517
Source
clinicaltrials.gov
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