Clinical trial NCT06452277: 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 of the Human Epidermal Growth Factor Receptor 2 (HER2)
Official title: A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Non-small Cell Lung Cancer
HER2 Mutation
Keywords: NSCLC
ERBB2 mutation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Primary outcomes:
measure: Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 4 years.
measure: Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
timeFrame: Up to approximately 4 years
measure: Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator
timeFrame: Up to approximately 4 years
measure: Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator
timeFrame: Up to approximately 4 years
measure: Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
timeFrame: Up to approximately 4 years
measure: Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
timeFrame: Up to approximately 4 years
measure: Duration of response (DOR) as assessed by BICR
timeFrame: Up to approximately 4 years
measure: Duration of response (DOR) as assessed by the investigator
timeFrame: Up to approximately 4 years
measure: Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity
timeFrame: Up to approximately 4 years
measure: Change from baseline in NSCLC-SAQ total score
timeFrame: Up to approximately 4 years
measure: Change from baseline in NSCLC-SAQ individual domain scores
timeFrame: Up to approximately 4 years
measure: Time to deterioration in NSCLC-SAQ total score
timeFrame: Up to approximately 4 years
measure: Time to deterioration in NSCLC-SAQ individual domain scores
timeFrame: Up to approximately 4 years
measure: Time to deterioration in EORTC QLQ-C30 physical functioning domain score
timeFrame: Up to approximately 4 years
measure: Change from baseline in EORTC QLQ-C30 physical functioning domain score
timeFrame: Up to approximately 4 years
measure: Change from baseline in EORTC QLQ-C30 global health status/QoL
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Patty & George Hoag Cancer Center
state: California
city: San Diego
country: United States
facility: UC San Diego Health - Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF) - Thoracic Surgery and Oncology Clinic
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Miramar
country: United States
facility: Memorial Cancer Institute at Miramar
state: Florida
city: Orlando
country: United States
facility: AdventHealth Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center - Magnolia Campus
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute - Atlanta
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: The U Chicago Medicine Comprehensive Cancer Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center - University Campus
state: Massachusetts
city: Farmington Hills
country: United States
facility: Profound Research -OMG - TriAtria Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: Profound Research - OMG - Royal Oak Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: New Hyde Park
country: United States
facility: R.J. Zuckerberg Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute - Franz Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Caba
country: Argentina
facility: Fundación Cenit para la Investigación en Neurociencias
state: Ciudad Auton. De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
city: Córdoba
country: Argentina
facility: Centro Médico Privado CEMAIC
city: TBC
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento (IADT)
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clínicas, Clínica Viedma
city: Blacktown
country: Australia
facility: Blacktown Cancer & Haematology Centre
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Hospital Newcastle
state: New South Wales
city: Buderim
country: Australia
facility: University of the Sunshine Coast
city: Garran
country: Australia
facility: The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC)
city: Heidelberg
country: Australia
facility: Austin Hospital - Olivia Newton John Cancer Research Institute
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
city: Wien
country: Austria
facility: Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
city: Wien
country: Austria
facility: Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg - Pneumology Department
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta | Clinical Trial Center - Pneumology
state: West-Flanders
city: Antwerpen
country: Belgium
facility: Antwerp University Hospital | Oncology Department
city: Recife
country: Brazil
facility: Rede DoR Recife - PE
state: Pernambuco
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Centro de Pesquisa da Clínica de Oncologia Reichow
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base | Integrated Research Center
state: Sao Paulo
city: Bauru
country: Brazil
facility: NAIC - Instituto do Cancer
city: Brasilia
country: Brazil
facility: Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
city: Fortaleza
country: Brazil
facility: Pronutrir Fortaleza - CE
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes
city: Sao Paulo
country: Brazil
facility: A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
city: Sao Paulo
country: Brazil
facility: Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
city: Panagyurishte
country: Bulgaria
facility: MHAT Uni Hospital
state: Pazardzhik
city: Pleven
country: Bulgaria
facility: MHAT "Heart and brain" Pleven
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT Park Hospital EOOD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Sveta Sofia"
city: Sofia
country: Bulgaria
facility: MHAT Serdika
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
city: Varna
country: Bulgaria
facility: MHAT Sveta Marina EAD
city: Brampton
country: Canada
facility: Brampton Civic Hospital - Oncology
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital - Department of Pulmonary Oncology
state: Quebec
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiaotong University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: The People's Liberation Army General Hospital (Beijing 301 Hospital)
city: Beijing
country: China
facility: Beijing chest hospital, Capital Medical University
city: Chengdu
country: China
facility: University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
city: Guangzhou
country: China
facility: Guangzhou Medical University - The First Affiliated Hospital
city: Jinan
country: China
facility: Shandong University - Shandong Cancer Hospital
city: Linyi
country: China
facility: LinYi Cancer Hospital (Linyi Tumor Hospital)
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
city: Nanning
country: China
facility: Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
city: Shanghai
country: China
facility: Fudan University - Zhongshan Hospital
city: Xiamen
country: China
facility: Xiamen University - The First Affiliated Hospital
city: Zlin
country: Czechia
facility: Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
state: Zlinsky Kraj
city: Brno
country: Czechia
facility: Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
city: Nový Jicín
country: Czechia
facility: Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologie
city: Olomouc
country: Czechia
facility: Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
city: Ostrava - Vítkovice
country: Czechia
facility: Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddelení
city: Aalborg
country: Denmark
facility: Aalborg University hospital - oncology department
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen OE
country: Denmark
facility: Rigshospitalet - Kræftbehandling
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup - Medicinsk afdeling
city: Odense C
country: Denmark
facility: Odense University Hospital - Oncology Department
city: Helsinki
country: Finland
facility: Docrates Mehiläinen Syöpäsairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Bordeaux
country: France
facility: Institut Bergonie - Unicancer Nouvelle Aquitaine
city: Brest
country: France
facility: Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Creteil - Service de pneumologie
city: La Tronche
country: France
facility: Centre Hospitalier Michallon Grenoble - Service pneumologie
city: Lille
country: France
facility: Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
city: Montpellier
country: France
facility: hopital Arnaud de Villeneuve CHU Montpellier - service oncologie thoracique
city: Mulhouse
country: France
facility: hopital Emile Muller - Service Pneumologie
city: Nantes
country: France
facility: Hopital Nord Laennec - Oncologie medicale thoracique et digestive
city: Nice
country: France
facility: Centre Antoine Lacassagne - Departement Oncologie
city: Paris
country: France
facility: hopital cochin APHP - service de pneumologie
city: Paris
country: France
facility: Institut Curie - Paris - Oncologie medicale
city: Pierre Bénite
country: France
facility: hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
city: Rouen
country: France
facility: CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
city: Saint-Herblain
country: France
facility: Institut de Cancerologie Ouest - Saint-Herblain
city: Suresnes
country: France
facility: Hopital Foch - Oncologie digestive et thoracique
city: Villejuif Cedex
country: France
facility: Gustave Roussy - Departement Oncologie-Radiotherapie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
state: Hessen
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
city: Hemer
country: Germany
facility: Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
city: Athens
country: Greece
facility: ?enry Durant Hospital Center-4th Oncology Department and Clinical Trials Unit
city: Athens
country: Greece
facility: University of Athens Medical School-Sotiria General Hospital - 3rd Dept of Medicine & Medical Oncology
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
city: Chaidari
country: Greece
facility: University General Hospital ATTIKON, Department of Internal Medicine IV
city: Chaidari
country: Greece
facility: University General Hospital of Athens "ATTIKON"
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Piraeus
country: Greece
facility: Metropolitan Hospital- 4th Oncology Clinic
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloniki
country: Greece
facility: PAPANIKOLAOU General Hospital of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital Hong Kong
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Ashdod
country: Israel
facility: Assuta Ashdod Public Hospital (R.A)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center- Legacy Heritage Cancer Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center (SZMC)
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Avellino
country: Italy
facility: AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
state: Piemonte
city: Padova
country: Italy
facility: Istituto Oncologico Veneto_Padova - UOC Oncologia 2
state: Veneto
city: Firenze
country: Italy
facility: Careggi University Hospital - Oncologia Clinica
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi Lecce - Oncologia
city: Milano
country: Italy
facility: Ospedale San Raffaele s.r.l. - Oncologia Medica
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
city: Varese
country: Italy
facility: ASST Sette Laghi_Ospedale Macchi - Oncologia
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School - Nippon Medical School Hospital - Cancer Center
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube
country: Japan
facility: National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbugdo
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital
state: Selangor
city: Shah Alam
country: Malaysia
facility: Columbia Asia Hospital Bukit Rimau
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Sunway Medical Centre
state: Selangor
city: Cheras
country: Malaysia
facility: University Hospital Kebangsaan Malaysia
city: George Town,
country: Malaysia
facility: Gleneagles Penang Medical Center
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Perai
country: Malaysia
facility: Sunway Medical Centre Penang
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerología
state: Distrito Federal
city: Cdmx
country: Mexico
facility: Oncare Viaducto Nápoles
city: Naucalpan
country: Mexico
facility: Oncología Integral Satélite
city: Nuevo León
country: Mexico
facility: Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
city: San Pedro Garza García
country: Mexico
facility: ONCARE Treatment Center
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center | Afdeling Interne Geneeskunde
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
state: Mazowieckie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano | Clinical Research Center
state: Porto
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
city: Lisboa
country: Portugal
facility: CHULN - Hospital Pulido Valente
city: Porto
country: Portugal
facility: IPO Porto
city: Flore?ti
country: Romania
facility: Radiotherapy Center Cluj SRL
state: Comuna Floresti
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Cluj-Napoca
country: Romania
facility: CardioMed S.R.L.
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
city: Craiova
country: Romania
facility: Sc Oncolab Srl
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Ovidiu
country: Romania
facility: S.C Ovidius Clinical Hospital SRL - Oncology Department
city: Timisoara
country: Romania
facility: Oncocenter
city: Singapore
country: Singapore
facility: Raffles Cancer Centre
city: Singapore
country: Singapore
facility: OncoCare Cancer Centre | Gleneagles Medical Centre
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Curie Oncology | Farrer
city: Poprad
country: Slovakia
facility: POKO Poprad s.r.o.
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro De Majadahonda - Oncologia
state: Madrid
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna (CHUAC)
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
city: Barcelona
country: Spain
facility: Hospital Quiron Dexeus - Oncologia
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon | Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal - Oncologia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)
city: Pamplona
country: Spain
facility: Hospital Universitario De Navarra - Oncologia
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia (IVO
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe - Oncologia
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Umeå
country: Sweden
facility: Norrland University Hospital - Cancercentrum
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
city: Fribourg
country: Switzerland
facility: HFR Freiburg - Kantonsspital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Kaohsiung
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: TNN
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center, Liouyine
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH) - Cancer Research Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bilkent Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Marmara University Hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Kadikoy
country: Turkey
facility: Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi
city: Kucukcekmece
country: Turkey
facility: I.A.Ü. VM Medical Park Florya Hastanesi
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi
city: Yenimahalle
country: Turkey
facility: Ankara Etlik Sehir Hastanesi
city: Yuregir
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi
city: Dnipro
country: Ukraine
facility: LLC "RDP Ukraine" - Medical Department
city: Kropyvnytskyi
country: Ukraine
facility: Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
city: Kyiv
country: Ukraine
facility: Limited Liability Company "MedOffice Group Medical Center"
city: Kyiv
country: Ukraine
facility: Medical Center LLC "Verum Expert Clinic"
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncology Center
city: Rivne
country: Ukraine
facility: Municipal Enterprise 'Rivne Regional Antitumor Center" of the Rivne Regional Council"
city: Uzhhorod
country: Ukraine
facility: MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: Devon
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: North Ireland
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Cardiff
country: United Kingdom
facility: Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials Unit
Study officials:
References: