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Trial Title: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

NCT ID: NCT06452277

Condition: Advanced Non-small Cell Lung Cancer
HER2 Mutation

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed

Conditions: Keywords:
NSCLC
ERBB2 mutation

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BAY2927088
Description: Tablet, oral
Arm group label: BAY2927088

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Intravenous (IV) infusion
Arm group label: Standard of care (SoC)

Intervention type: Drug
Intervention name: Cisplatin
Description: IV infusion
Arm group label: Standard of care (SoC)

Intervention type: Drug
Intervention name: Carboplatin
Description: IV infusion
Arm group label: Standard of care (SoC)

Intervention type: Drug
Intervention name: Pemetrexed
Description: IV infusion
Arm group label: Standard of care (SoC)

Summary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent. - Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC). - Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited. - No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening. - Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information. Exclusion Criteria: - Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance: - a. in situ cancers of cervix, breast, or skin, - b. superficial bladder cancer (Ta, Tis and T1), - c. limited-stage prostate cancer, - d. basal or squamous cancers of the skin. - Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD. - Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention. - Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0). - History of severe hypersensitivity reaction to treatment with a monoclonal antibody. - Prior radiotherapy outside of the brain within 21 days of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hoag Memorial Hospital - Center for Research & Education

Address:
City: Newport Beach
Zip: 92663
Country: United States

Status: Withdrawn

Facility:
Name: UC San Diego Health - Moores Cancer Center

Address:
City: San Diego
Zip: 92093-1503
Country: United States

Status: Not yet recruiting

Facility:
Name: University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

Address:
City: Santa Monica
Zip: 90404-2023
Country: United States

Status: Not yet recruiting

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Whittier
Zip: 90602
Country: United States

Status: Not yet recruiting

Facility:
Name: Memorial Healthcare System

Address:
City: Hollywood
Zip: 33021
Country: United States

Status: Not yet recruiting

Facility:
Name: The U Chicago Medicine Comprehensive Cancer Center

Address:
City: Chicago
Zip: 60805
Country: United States

Status: Not yet recruiting

Facility:
Name: University of Maryland

Address:
City: Baltimore
Zip: 21201
Country: United States

Status: Not yet recruiting

Facility:
Name: UMass Memorial Medical Center - University Campus

Address:
City: Worcester
Zip: 01655-0002
Country: United States

Status: Not yet recruiting

Facility:
Name: Profound Research LLC

Address:
City: Farmington Hills
Zip: 48334
Country: United States

Status: Not yet recruiting

Facility:
Name: Northwell Health Cancer Institute - R.J. Zuckerberg Cancer Center (Monter Cancer Center) - Center for Advanced Medicine Location

Address:
City: New Hyde Park
Zip: 11042-1118
Country: United States

Status: Not yet recruiting

Facility:
Name: Providence Cancer Institute - Franz Clinic

Address:
City: Portland
Zip: 97213-2933
Country: United States

Status: Not yet recruiting

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Not yet recruiting

Facility:
Name: Fundación Cenit para la Investigación en Neurociencias

Address:
City: Caba
Zip: C1125 ABD
Country: Argentina

Status: Withdrawn

Facility:
Name: Hospital Italiano de Buenos Aires

Address:
City: Buenos Aires
Zip: C1199ABB
Country: Argentina

Status: Withdrawn

Facility:
Name: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

Address:
City: Buenos Aires
Zip: C1431FWO
Country: Argentina

Status: Withdrawn

Facility:
Name: Centro Médico Privado CEMAIC

Address:
City: Córdoba
Zip: X5008HHW
Country: Argentina

Status: Withdrawn

Facility:
Name: Instituto Argentino de Diagnostico y Tratamiento (IADT)

Address:
City: TBC
Zip: TBC
Country: Argentina

Status: Withdrawn

Facility:
Name: Centro de Investigaciones Clínicas, Clínica Viedma

Address:
City: Viedma
Zip: R8500
Country: Argentina

Status: Withdrawn

Facility:
Name: Blacktown Cancer & Haematology Centre

Address:
City: Blacktown
Zip: 2148
Country: Australia

Status: Not yet recruiting

Facility:
Name: Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit

Address:
City: Concord
Zip: 2139
Country: Australia

Status: Not yet recruiting

Facility:
Name: Calvary Mater Hospital Newcastle

Address:
City: Waratah
Zip: 2298
Country: Australia

Status: Not yet recruiting

Facility:
Name: University of the Sunshine Coast

Address:
City: Buderim
Zip: 4556
Country: Australia

Status: Not yet recruiting

Facility:
Name: The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC)

Address:
City: Garran
Zip: 2605
Country: Australia

Status: Not yet recruiting

Facility:
Name: Austin Hospital - Olivia Newton John Cancer Research Institute

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Status: Not yet recruiting

Facility:
Name: Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III

Address:
City: Salzburg
Zip: 5020
Country: Austria

Status: Not yet recruiting

Facility:
Name: Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde

Address:
City: Salzburg
Zip: 5020
Country: Austria

Status: Not yet recruiting

Facility:
Name: Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie

Address:
City: Wien
Zip: 1090
Country: Austria

Status: Not yet recruiting

Facility:
Name: Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik

Address:
City: Wien
Zip: 1210
Country: Austria

Status: Not yet recruiting

Facility:
Name: Antwerp University Hospital | Oncology Department

Address:
City: Antwerpen
Zip: 2650
Country: Belgium

Status: Not yet recruiting

Facility:
Name: UZ Leuven Gasthuisberg

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Not yet recruiting

Facility:
Name: AZ Delta | Clinical Trial Center - Pneumology

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Status: Not yet recruiting

Facility:
Name: Rede DoR Recife - PE

Address:
City: Recife
Zip: 50070-480
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Address:
City: Natal
Zip: 59040-000
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Fundacao Pio XII - Hospital de Cancer de Barretos

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Hospital de Base | Integrated Research Center

Address:
City: São José do Rio Preto
Zip: 15090-000
Country: Brazil

Status: Not yet recruiting

Facility:
Name: NAIC - Instituto do Cancer

Address:
City: Bauru
Zip: 17033-490
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Centro de Pesquisa da Clínica de Oncologia Reichow

Address:
City: Blumenau
Zip: 89010-340
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia

Address:
City: Brasilia
Zip: 71635-610
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Pronutrir Fortaleza - CE

Address:
City: Fortaleza
Zip: 60810-180
Country: Brazil

Status: Not yet recruiting

Facility:
Name: A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante

Address:
City: Sao Paulo
Zip: 01323-030
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Hospital Sirio Libanes

Address:
City: Sao Paulo
Zip: 01409-000
Country: Brazil

Status: Not yet recruiting

Facility:
Name: Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima

Address:
City: Sao Paulo
Zip: 04538-132
Country: Brazil

Status: Not yet recruiting

Facility:
Name: MHAT Uni Hospital

Address:
City: Panagyurishte
Zip: 4500
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: MHAT "Heart and brain" Pleven

Address:
City: Pleven
Zip: 5804
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: Complex Oncology Center - Plovdiv EOOD

Address:
City: Plovdiv
Zip: 4004
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: MHAT Park Hospital EOOD

Address:
City: Plovdiv
Zip: 4109
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: Multiprofile Hospital for Active Treatment "Sveta Sofia"

Address:
City: Sofia
Zip: 1404
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: MHAT Serdika

Address:
City: Sofia
Zip: 1632
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: MHAT Sofiamed

Address:
City: Sofia
Zip: 1797
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: Specialized Hospital for Active Treatment of Oncology

Address:
City: Sofia
Zip: 1797
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: MHAT Sveta Marina EAD

Address:
City: Varna
Zip: 9010
Country: Bulgaria

Status: Not yet recruiting

Facility:
Name: Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

Address:
City: Toronto
Zip: M5G 2C4
Country: Canada

Status: Not yet recruiting

Facility:
Name: Jewish General Hospital - Department of Pulmonary Oncology

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Status: Not yet recruiting

Facility:
Name: BC Cancer - The Vancouver Centre

Address:
City: Vancouver
Zip: V5Z 4E6
Country: Canada

Status: Not yet recruiting

Facility:
Name: Fujian Cancer Hospital

Address:
City: Fuzhou
Zip: 350014
Country: China

Status: Not yet recruiting

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Zip: 410013
Country: China

Status: Not yet recruiting

Facility:
Name: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Address:
City: Nanjing
Zip: 210008
Country: China

Status: Not yet recruiting

Facility:
Name: Jilin Cancer Hospital

Address:
City: Changchun
Zip: 130000
Country: China

Status: Not yet recruiting

Facility:
Name: West China Hospital Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Not yet recruiting

Facility:
Name: Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Status: Not yet recruiting

Facility:
Name: Cancer Hospital, Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100000
Country: China

Status: Not yet recruiting

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Not yet recruiting

Facility:
Name: Beijing Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Status: Not yet recruiting

Facility:
Name: Beijing chest hospital, Capital Medical University

Address:
City: Beijing
Zip: 101149
Country: China

Status: Not yet recruiting

Facility:
Name: The People's Liberation Army General Hospital (Beijing 301 Hospital)

Address:
City: Beijing
Country: China

Status: Not yet recruiting

Facility:
Name: University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Not yet recruiting

Facility:
Name: Guangzhou Medical University - The First Affiliated Hospital

Address:
City: Guangzhou
Country: China

Status: Not yet recruiting

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Country: China

Status: Not yet recruiting

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Country: China

Status: Not yet recruiting

Facility:
Name: Shandong University - Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Status: Not yet recruiting

Facility:
Name: LinYi Cancer Hospital (Linyi Tumor Hospital)

Address:
City: Linyi
Country: China

Status: Not yet recruiting

Facility:
Name: Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)

Address:
City: Nanjing
Country: China

Status: Not yet recruiting

Facility:
Name: Guangxi Medical University (GXMU) - Affiliated Tumor Hospital

Address:
City: Nanning
Country: China

Status: Not yet recruiting

Facility:
Name: Shanghai Chest Hospital, Shanghai Jiaotong University

Address:
City: Shanghai
Zip: 200030
Country: China

Status: Not yet recruiting

Facility:
Name: Fudan University - Zhongshan Hospital

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Not yet recruiting

Facility:
Name: Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province

Address:
City: Taizhou
Zip: 317000
Country: China

Status: Not yet recruiting

Facility:
Name: Hubei Cancer Hospital

Address:
City: Wuhan
Country: China

Status: Not yet recruiting

Facility:
Name: Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech

Address:
City: Wuhan
Country: China

Status: Not yet recruiting

Facility:
Name: Xiamen University - The First Affiliated Hospital

Address:
City: Xiamen
Country: China

Status: Not yet recruiting

Facility:
Name: Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie

Address:
City: Zlin
Zip: 762 75
Country: Czechia

Status: Not yet recruiting

Facility:
Name: Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)

Address:
City: Brno
Zip: 602 00
Country: Czechia

Status: Not yet recruiting

Facility:
Name: Nemocnice AGEL Novy Jicin a.s., Oddelení radioterapie a onkologie

Address:
City: Novy Jicin
Zip: 741 01
Country: Czechia

Status: Not yet recruiting

Facility:
Name: Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy

Address:
City: Olomouc
Zip: 77900
Country: Czechia

Status: Withdrawn

Facility:
Name: Vitkovicka nemocnice a.s.

Address:
City: Ostrava
Zip: 703 84
Country: Czechia

Status: Not yet recruiting

Facility:
Name: Aalborg University Hospital

Address:
City: Aalborg
Zip: 9000
Country: Denmark

Status: Not yet recruiting

Facility:
Name: Aarhus Universitetshospital

Address:
City: Aarhus N
Zip: 8200
Country: Denmark

Status: Not yet recruiting

Facility:
Name: Rigshospitalet - Kræftbehandling

Address:
City: Copenhagen
Zip: 2100
Country: Denmark

Status: Not yet recruiting

Facility:
Name: Regionshospitalet Gødstrup - Medicinsk afdeling

Address:
City: Herning
Zip: 7400
Country: Denmark

Status: Withdrawn

Facility:
Name: Odense University Hospital - Oncology Department

Address:
City: Odense C
Zip: 5000
Country: Denmark

Status: Not yet recruiting

Facility:
Name: Docrates Cancer Center

Address:
City: Helsinki
Zip: FIN-00180
Country: Finland

Status: Not yet recruiting

Facility:
Name: Turun yliopistollinen keskussairaala

Address:
City: Turku
Zip: 20521
Country: Finland

Status: Not yet recruiting

Facility:
Name: Institut Bergonié - Unicancer Nouvelle Aquitaine

Address:
City: Bordeaux Cedex
Zip: 33076
Country: France

Status: Not yet recruiting

Facility:
Name: Institut de Cancérologie et d'Imagerie

Address:
City: Brest
Zip: 29200
Country: France

Status: Not yet recruiting

Facility:
Name: Centre Hospitalier Intercommunal Créteil - Service de pneumologie

Address:
City: Créteil
Zip: 94010
Country: France

Status: Not yet recruiting

Facility:
Name: CHU Grenoble Alpes - Pneumologie

Address:
City: La Tronche
Country: France

Status: Not yet recruiting

Facility:
Name: Institut Coeur Poumon - CHRU Lille - Pôle Cardio-vasculaire et pulmonaire

Address:
City: Lille
Zip: 59000
Country: France

Status: Not yet recruiting

Facility:
Name: CHU Limoges - Unité oncologie thoracique

Address:
City: Limoges
Zip: 87042
Country: France

Status: Not yet recruiting

Facility:
Name: Hôpital Arnaud de Villeneuve - Montpellier

Address:
City: Montpellier
Zip: 34059
Country: France

Status: Not yet recruiting

Facility:
Name: Hôpital Emile Muller - Mulhouse

Address:
City: Mulhouse
Zip: 68051
Country: France

Status: Not yet recruiting

Facility:
Name: Institut Curie - Ulm - Paris

Address:
City: PARIS cedex 5
Zip: 75248
Country: France

Status: Not yet recruiting

Facility:
Name: Hôpital Cochin - Cancérologie

Address:
City: Paris
Zip: 75014
Country: France

Status: Not yet recruiting

Facility:
Name: Hôpital Lyon Sud - HCL - Service de pneumologie aiguë spécialisée et cancérologie thoracique

Address:
City: Pierre Bénite
Zip: 69495
Country: France

Status: Not yet recruiting

Facility:
Name: CHU de Rouen - Pneumologie

Address:
City: Rouen
Zip: 76031
Country: France

Status: Not yet recruiting

Facility:
Name: Institut de Cancérologie de l'Ouest - Saint Herblain

Address:
City: Saint-Herblain
Zip: 44800
Country: France

Status: Not yet recruiting

Facility:
Name: Hôpital Foch - Oncologie digestive et thoracique

Address:
City: Suresnes
Zip: 92150
Country: France

Status: Not yet recruiting

Facility:
Name: Institut Gustave Roussy - Département de Médecine Oncologique

Address:
City: Villejuif Cedex
Zip: 94805
Country: France

Status: Not yet recruiting

Facility:
Name: Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie

Address:
City: Gießen
Zip: 35392
Country: Germany

Status: Not yet recruiting

Facility:
Name: Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

Address:
City: Köln
Zip: 51109
Country: Germany

Status: Not yet recruiting

Facility:
Name: Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)

Address:
City: Essen
Zip: 45147
Country: Germany

Status: Not yet recruiting

Facility:
Name: Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin

Address:
City: Hemer
Zip: 58675
Country: Germany

Status: Not yet recruiting

Facility:
Name: Klinikum Nürnberg

Address:
City: Nürnberg
Zip: 90419
Country: Germany

Status: Not yet recruiting

Facility:
Name: Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin

Address:
City: Stuttgart
Zip: 70376
Country: Germany

Status: Not yet recruiting

Facility:
Name: University of Athens Medical School-Sotiria General Hospital

Address:
City: Athens
Zip: 11527
Country: Greece

Status: Not yet recruiting

Facility:
Name: University of Athens Medical School- Alexandra General Hospital of Athens

Address:
City: Athens
Zip: 11528
Country: Greece

Status: Not yet recruiting

Facility:
Name: Metropolitan Hospital- 4th Oncology Clinic

Address:
City: Athens
Zip: 18547
Country: Greece

Status: Not yet recruiting

Facility:
Name: University General Hospital ATTIKON, Department of Internal Medicine IV

Address:
City: Chaidari
Zip: 12462
Country: Greece

Status: Not yet recruiting

Facility:
Name: University General Hospital of Athens "ATTIKON"

Address:
City: Chaidari
Zip: 12462
Country: Greece

Status: Not yet recruiting

Facility:
Name: University General Hospital of Larissa

Address:
City: Larissa
Zip: 41110
Country: Greece

Status: Not yet recruiting

Facility:
Name: Bioclinic Thessaloniki

Address:
City: Thessaloniki
Zip: 54622
Country: Greece

Status: Not yet recruiting

Facility:
Name: PAPANIKOLAOU General Hospital of Thessaloniki

Address:
City: Thessaloniki
Zip: 57010
Country: Greece

Status: Not yet recruiting

Facility:
Name: Prince of Wales Hospital

Address:
City: Hong Kong
Zip: MISSING
Country: Hong Kong

Status: Not yet recruiting

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: MISSING
Country: Hong Kong

Status: Not yet recruiting

Facility:
Name: Queen Elizabeth Hospital Hong Kong

Address:
City: Hong Kong
Country: Hong Kong

Status: Not yet recruiting

Facility:
Name: Hong Kong United Oncology Centre

Address:
City: Kowloon
Zip: 0
Country: Hong Kong

Status: Not yet recruiting

Facility:
Name: Budapesti Uzsoki Utcai Korhaz

Address:
City: Budapest
Zip: 1145
Country: Hungary

Status: Not yet recruiting

Facility:
Name: Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Address:
City: Tatabanya
Zip: 2800
Country: Hungary

Status: Not yet recruiting

Facility:
Name: Assuta Ashdod Public Hospital (R.A)

Address:
City: Ashdod
Zip: 7747629
Country: Israel

Status: Not yet recruiting

Facility:
Name: Soroka Medical Center- Legacy Heritage Cancer Center

Address:
City: Be'er Sheva
Zip: 8410101
Country: Israel

Status: Not yet recruiting

Facility:
Name: Shaare Zedek Medical Center (SZMC)

Address:
City: Jerusalem
Zip: 91031
Country: Israel

Status: Not yet recruiting

Facility:
Name: Tel-Aviv Sourasky Medical Center

Address:
City: Tel Aviv
Zip: 6423906
Country: Israel

Status: Not yet recruiting

Facility:
Name: AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica

Address:
City: Avellino
Zip: 83100
Country: Italy

Status: Not yet recruiting

Facility:
Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica

Address:
City: Bologna
Zip: 40138
Country: Italy

Status: Not yet recruiting

Facility:
Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica

Address:
City: Meldola
Zip: 47014
Country: Italy

Status: Not yet recruiting

Facility:
Name: Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

Address:
City: Aviano
Zip: 33081
Country: Italy

Status: Not yet recruiting

Facility:
Name: I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2

Address:
City: Roma
Zip: 00128
Country: Italy

Status: Not yet recruiting

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Not yet recruiting

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Address:
City: Milano
Zip: 20133
Country: Italy

Status: Not yet recruiting

Facility:
Name: Istituto Europeo di Oncologia s.r.l - Oncologia Toracica

Address:
City: Milano
Zip: 20141
Country: Italy

Status: Not yet recruiting

Facility:
Name: Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

Address:
City: Rozzano
Zip: 20089
Country: Italy

Status: Not yet recruiting

Facility:
Name: Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

Address:
City: Orbassano
Zip: 10043
Country: Italy

Status: Not yet recruiting

Facility:
Name: Istituto Oncologico Veneto_Padova - UOC Oncologia 2

Address:
City: Padova
Zip: 35128
Country: Italy

Status: Not yet recruiting

Facility:
Name: Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia

Address:
City: Verona
Zip: 37134
Country: Italy

Status: Not yet recruiting

Facility:
Name: National Hospital Organization Nagoya Medical Center

Address:
City: Nagoya
Zip: 460-0001
Country: Japan

Status: Not yet recruiting

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Status: Not yet recruiting

Facility:
Name: Hokkaido University Hospital

Address:
City: Sapporo
Zip: 060-8648
Country: Japan

Status: Not yet recruiting

Facility:
Name: National Hospital Organization Himeji Medical Center

Address:
City: Himeji
Zip: 670-8520
Country: Japan

Status: Not yet recruiting

Facility:
Name: Kobe University Hospital

Address:
City: Kobe
Zip: 650-0017
Country: Japan

Status: Not yet recruiting

Facility:
Name: Kitasato University Hospital

Address:
City: Sagamihara
Zip: 252-0375
Country: Japan

Status: Not yet recruiting

Facility:
Name: Sendai Kousei Hospital

Address:
City: Sendai
Zip: 980-0873
Country: Japan

Status: Not yet recruiting

Facility:
Name: Kansai Medical University Hospital

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Status: Not yet recruiting

Facility:
Name: Kindai University Hospital

Address:
City: Osakasayama
Zip: 589-8511
Country: Japan

Status: Not yet recruiting

Facility:
Name: Saitama Cancer Center

Address:
City: Kitaadachi-gun
Zip: 362-0806
Country: Japan

Status: Recruiting

Facility:
Name: Nippon Medical School - Nippon Medical School Hospital - Cancer Center

Address:
City: Bunkyo-ku
Zip: 113-8603
Country: Japan

Status: Not yet recruiting

Facility:
Name: Tottori University Hospital

Address:
City: Yonago
Zip: 683-8504
Country: Japan

Status: Not yet recruiting

Facility:
Name: National Hospital Organization Kyushu Medical Center

Address:
City: Fukuoka
Zip: 810-8563
Country: Japan

Status: Not yet recruiting

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Status: Not yet recruiting

Facility:
Name: Osaka International Cancer Institute

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Status: Not yet recruiting

Facility:
Name: National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)

Address:
City: Ube
Zip: 755-0241
Country: Japan

Status: Not yet recruiting

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Gyeongsang National University Hospital

Address:
City: Jinju-si
Zip: 52727
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Yangsan-si
Zip: 50612
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 3080
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun Gun
Zip: 58128
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 6351
Country: Korea, Republic of

Status: Not yet recruiting

Facility:
Name: Sunway Medical Centre

Address:
City: Subang Jaya
Zip: 47500
Country: Malaysia

Status: Not yet recruiting

Facility:
Name: University Hospital Kebangsaan Malaysia

Address:
City: Cheras
Zip: 56000
Country: Malaysia

Status: Not yet recruiting

Facility:
Name: University Malaya Medical Centre

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Status: Recruiting

Facility:
Name: Sunway Medical Centre Penang

Address:
City: Perai
Zip: 13700
Country: Malaysia

Status: Not yet recruiting

Facility:
Name: Beacon Hospital

Address:
City: Petaling Jaya, Selangor
Zip: 46050
Country: Malaysia

Status: Not yet recruiting

Facility:
Name: Columbia Asia Hospital Bukit Rimau

Address:
City: Shah Alam
Zip: 40460
Country: Malaysia

Status: Not yet recruiting

Facility:
Name: Instituto Nacional de Cancerología

Address:
City: México
Zip: 14080
Country: Mexico

Status: Not yet recruiting

Facility:
Name: Oncare Viaducto Nápoles

Address:
City: Cdmx
Zip: 3810
Country: Mexico

Status: Not yet recruiting

Facility:
Name: Oncología Integral Satélite

Address:
City: Naucalpan
Zip: 53100
Country: Mexico

Status: Not yet recruiting

Facility:
Name: Hospital Universitrio Dr. José Eleuterio González. Servicio de Oincología

Address:
City: Nuevo León
Zip: 64460
Country: Mexico

Status: Not yet recruiting

Facility:
Name: ONCARE Treatment Center

Address:
City: San Pedro Garza García
Zip: 66220
Country: Mexico

Status: Not yet recruiting

Facility:
Name: Nederlands Kanker Instituut

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Status: Not yet recruiting

Facility:
Name: Radboud University Medical Center | Afdeling Interne Geneeskunde

Address:
City: Nijmegen
Zip: 6500 HB
Country: Netherlands

Status: Not yet recruiting

Facility:
Name: Uniwersytecki Szpital Kliniczny w Bialymstoku

Address:
City: Bialystok
Zip: 15-276
Country: Poland

Status: Withdrawn

Facility:
Name: Swietokrzyskie Centrum Onkologii

Address:
City: Kielce
Zip: 25-734
Country: Poland

Status: Not yet recruiting

Facility:
Name: SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow

Address:
City: Lodz
Zip: 92-213
Country: Poland

Status: Not yet recruiting

Facility:
Name: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku

Address:
City: Otwock
Zip: 05-400
Country: Poland

Status: Not yet recruiting

Facility:
Name: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Address:
City: Poznan
Zip: 60-569
Country: Poland

Status: Not yet recruiting

Facility:
Name: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

Address:
City: Wroclaw
Zip: 53-413
Country: Poland

Status: Not yet recruiting

Facility:
Name: Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

Address:
City: Lisboa
Zip: 1400-038
Country: Portugal

Status: Not yet recruiting

Facility:
Name: CHULN - Hospital Pulido Valente

Address:
City: Lisboa
Zip: 1769-001
Country: Portugal

Status: Not yet recruiting

Facility:
Name: ULSM - Hospital Pedro Hispano

Address:
City: Matosinhos
Zip: 4464-513
Country: Portugal

Status: Not yet recruiting

Facility:
Name: IPO Porto

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Status: Not yet recruiting

Facility:
Name: Radiotherapy Center Cluj SRL

Address:
City: Flore?ti
Zip: 407280
Country: Romania

Status: Not yet recruiting

Facility:
Name: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II

Address:
City: Bucuresti
Zip: 22328
Country: Romania

Status: Not yet recruiting

Facility:
Name: Spitalul Clinic Coltea

Address:
City: Bucuresti
Zip: 30171
Country: Romania

Status: Not yet recruiting

Facility:
Name: CardioMed S.R.L.

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Status: Not yet recruiting

Facility:
Name: Institutul Oncologic Prof. Dr. Ion Chiricuta

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Status: Not yet recruiting

Facility:
Name: Sc Oncolab Srl

Address:
City: Craiova
Zip: 200385
Country: Romania

Status: Not yet recruiting

Facility:
Name: Centrul de Oncologie Sfantul Nectarie

Address:
City: Craiova
Zip: 200745
Country: Romania

Status: Not yet recruiting

Facility:
Name: Raffles Cancer Centre

Address:
City: Singapore
Zip: 188770
Country: Singapore

Status: Not yet recruiting

Facility:
Name: OncoCare Cancer Centre | Gleneagles Medical Centre

Address:
City: Singapore
Zip: 258499
Country: Singapore

Status: Not yet recruiting

Facility:
Name: Tan Tock Seng Hospital

Address:
City: Singapore
Zip: 308433
Country: Singapore

Status: Not yet recruiting

Facility:
Name: Curie Oncology | Farrer

Address:
City: Singapore
Zip: 329563
Country: Singapore

Status: Not yet recruiting

Facility:
Name: POKO Poprad s.r.o.

Address:
City: Poprad
Zip: 058 01
Country: Slovakia

Status: Not yet recruiting

Facility:
Name: Fakultna nemocnica Trnava

Address:
City: Trnava
Zip: 91775
Country: Slovakia

Status: Not yet recruiting

Facility:
Name: Hospital Universitario Clinica Puerta de Hierro

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Status: Not yet recruiting

Facility:
Name: Complejo Hospitalario Universitario A Coruna (CHUAC)

Address:
City: A Coruna
Zip: 15006
Country: Spain

Status: Not yet recruiting

Facility:
Name: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location

Address:
City: Badalona
Zip: 8916
Country: Spain

Status: Not yet recruiting

Facility:
Name: Hospital Quiron Dexeus

Address:
City: Barcelona
Zip: 08028
Country: Spain

Status: Not yet recruiting

Facility:
Name: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Not yet recruiting

Facility:
Name: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Not yet recruiting

Facility:
Name: Hospital General Universitario Gregorio Maranon | Oncologia

Address:
City: Madrid
Zip: 28009
Country: Spain

Status: Not yet recruiting

Facility:
Name: Fundacion Jimenez Diaz (Clinica de la Concepcion)

Address:
City: Madrid
Zip: 28040
Country: Spain

Status: Not yet recruiting

Facility:
Name: Complejo Hospitalario de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Status: Not yet recruiting

Facility:
Name: Fundacion Instituto Valenciano de Oncologia (IVO

Address:
City: Valencia
Zip: 46009
Country: Spain

Status: Not yet recruiting

Facility:
Name: Hospital Universitari i Politecnic La Fe | Oncologia

Address:
City: Valencia
Zip: 46026
Country: Spain

Status: Not yet recruiting

Facility:
Name: Skåne University Hospital

Address:
City: Lund
Zip: 221 85
Country: Sweden

Status: Not yet recruiting

Facility:
Name: Norrland University Hospital - Cancercentrum

Address:
City: Umeå
Zip: 90185
Country: Sweden

Status: Not yet recruiting

Facility:
Name: Kantonsspital Baden

Address:
City: Baden
Zip: 5404
Country: Switzerland

Status: Not yet recruiting

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Chung Shan Medical University Hospital

Address:
City: Taichung
Zip: 402306
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Chi-Mei Medical Center, Liouyine

Address:
City: Tainan
Zip: 736
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 100229
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: National Taiwan University Hospital (NTUH) - Cancer Research Center

Address:
City: Taipei
Zip: 10051
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Ankara Bilkent Sehir Hastanesi

Address:
City: Bilkent Çankaya
Zip: 6800
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Marmara University Hospital

Address:
City: Istanbul
Zip: 34899
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Ege Universitesi Tip Fakultesi

Address:
City: Izmir
Zip: 35100
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi

Address:
City: Kadikoy
Zip: 34722
Country: Turkey

Status: Not yet recruiting

Facility:
Name: I.A.Ü. VM Medical Park Florya Hastanesi

Address:
City: Kucukcekmece
Zip: 34295
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Sakarya Universitesi Egitim ve Arastirma Hastanesi

Address:
City: Sakarya
Zip: 54100
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Ankara Etlik Sehir Hastanesi

Address:
City: Yenimahalle
Zip: 6170
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Adana Sehir Egitim ve Arastirma Hastanesi

Address:
City: Yüregir
Zip: 1370
Country: Turkey

Status: Not yet recruiting

Facility:
Name: Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Multi-Type Hospital No.4

Address:
City: Dnipropetrovsk
Zip: 49102
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Verum Clinic

Address:
City: Kiev
Zip: 3039
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: P.L. Shupyk National Medical Academy of Post-Graduate Education - Kyiv city clinical Oncology Center

Address:
City: Kiev
Zip: 3115
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: St. Luke's Hospital (Medical and Diagnostic Center "Acinus'')

Address:
City: Kirovograd
Zip: 25006
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Limited Liability Company "MedOffice Group Medical Center"

Address:
City: Kyiv
Zip: 03189
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Volyn Regional Oncology Center

Address:
City: Lutsk
Zip: 43018
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Yuri Semenyuk Rivne Regional Clinical Hospital

Address:
City: Rivne
Zip: 33007
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Uzhhorod Central City Clinical Hospital

Address:
City: Uzhgorod
Zip: 88000
Country: Ukraine

Status: Not yet recruiting

Facility:
Name: Torbay Hospital

Address:
City: Torbay
Zip: TQ2 7AA
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Belfast City Hospital

Address:
City: Belfast
Zip: BT9 7AB
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Royal Surrey County Hospital

Address:
City: Guildford
Zip: GU2 7XX
Country: United Kingdom

Status: Not yet recruiting

Start date: August 28, 2024

Completion date: May 15, 2028

Lead sponsor:
Agency: Bayer
Agency class: Industry

Source: Bayer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06452277
https://clinicaltrials.bayer.com/study/22615

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