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En undersøgelse for at lære mere om, hvor godt BAY 2927088 virker, og hvor sikker den er sammenlignet med standardbehandling, hos deltagere, der har avanceret ikke-småcellet lungekræft (NSCLC) med mutationer i generne af Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)

3. november 2026 opdateret af: Bayer

Et fase 3 åbent, randomiseret, aktivt kontrolleret, multicenterforsøg til evaluering af effektiviteten og sikkerheden af oralt administreret BAY 2927088 sammenlignet med standardbehandling som førstelinjebehandling hos patienter med lokalt avanceret eller metastatisk ikke-småcellet lungekræft (NSCLC) Med HER2-aktiverende mutationer

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 means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly.

The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing.

The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation.

The study participants will receive one of the study treatments:

Sevabertinib as a tablet taken by mouth twice a day
Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover.

Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment.

During the study, the research team will:

do scans such as CT, PET, MRI, or X-rays to check the cancer
Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram.
do pregnancy tests when needed
ask how the participants are feeling and whether they have had any adverse events or other health problems 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.

Studieoversigt

Status

Rekruttering

Betingelser

Advanced Non-small Cell Lung Cancer, HER2 Mutation

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

444

Fase

Fase 3

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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Bayer Clinical Trials Contact
Telefonnummer: 18888422937
E-mail: clinical-trials-contact@bayer.com

Studiesteder

Argentina
- - Buenos Aires, Argentina, C1199ABB
    - Trukket tilbage
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, C1431FWO
    - Trukket tilbage
    - Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
  - Buenos Aires, Argentina, C1125 ABD
    - Trukket tilbage
    - Fundación Cenit para la Investigación en Neurociencias
  - Córdoba, Argentina, X5008HHW
    - Trukket tilbage
    - Centro Médico Privado CEMAIC
- Buenos Aires
  - TBC, Buenos Aires, Argentina, B1841
    - Trukket tilbage
    - Instituto Argentino de Diagnostico y Tratamiento (IADT)
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, R8500ACE
    - Trukket tilbage
    - Centro de Investigaciones Clínicas, Clínica Viedma
Australien
- New South Wales
  - Blacktown, New South Wales, Australien, 2148
    - Aktiv, ikke rekrutterende
    - NSW Health - Blacktown Hospital
  - Concord, New South Wales, Australien, 2139
    - Afsluttet
    - Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
  - Waratah, New South Wales, Australien, 2298
    - Aktiv, ikke rekrutterende
    - Calvary Mater Hospital Newcastle - Oncology
- Queensland
  - Buderim, Queensland, Australien, 4556
    - Trukket tilbage
    - University of the Sunshine Coast
  - Toowoomba, Queensland, Australien, 4350
    - Trukket tilbage
    - Toowoomba Hospital Oncology Clinical Trials
- Victoria
  - Heidelberg, Victoria, Australien, 3084
    - Aktiv, ikke rekrutterende
    - Austin Hospital - Olivia Newton John Cancer Research Institute
Belgien
- Antwerp
  - Antwerp, Antwerp, Belgien, 2650
    - Trukket tilbage
    - Antwerp University Hospital | Oncology Department
- Flemish Brabant
  - Leuven, Flemish Brabant, Belgien, 3000
    - Aktiv, ikke rekrutterende
    - UZ Leuven Gasthuisberg - Pneumology Department
- West Flanders
  - Roeselare, West Flanders, Belgien, 8800
    - Aktiv, ikke rekrutterende
    - AZ Delta | Clinical Trial Center - Pneumology
Brasilien
- - São Paulo, Brasilien, 01323-030
    - Rekruttering
    - A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
  - São Paulo, Brasilien, 90020-090
    - Rekruttering
    - Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
  - São Paulo, Brasilien, 01308-050
    - Rekruttering
    - Hospital Sirio Libanes
  - São Paulo, Brasilien, 71635-610
    - Trukket tilbage
    - Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
- Ceará
  - Fortaleza, Ceará, Brasilien, 60810-180
    - Rekruttering
    - Pronutrir Fortaleza - CE
- Federal District
  - Brasília, Federal District, Brasilien, 04538-132
    - Rekruttering
    - Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
- Pernambuco
  - Recife, Pernambuco, Brasilien, 50070-480
    - Rekruttering
    - Rede DoR Recife - PE
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brasilien, 59040-000
    - Rekruttering
    - Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
- Santa Catarina
  - Blumenau, Santa Catarina, Brasilien, 89010-340
    - Rekruttering
    - Centro de Pesquisa da Clínica de Oncologia Reichow
- São Paulo
  - Bauru, São Paulo, Brasilien, 17033-490
    - Rekruttering
    - NAIC - Instituto do Cancer
  - Jaú, São Paulo, Brasilien, 14784-400
    - Rekruttering
    - Fundacao Pio XII - Hospital de Cancer de Barretos
  - São José do Rio Preto, São Paulo, Brasilien, 15090-000
    - Trukket tilbage
    - Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
Bulgarien
- Pazardzhik Province
  - Panagyurishte, Pazardzhik Province, Bulgarien, 4500
    - Ikke rekrutterer endnu
    - MHAT Uni Hospital
- Pleven Province
  - Pleven, Pleven Province, Bulgarien, 5804
    - Ikke rekrutterer endnu
    - MHAT "Heart and brain" Pleven
- Plovdiv Province
  - Plovdiv, Plovdiv Province, Bulgarien, 4109
    - Trukket tilbage
    - MHAT Park Hospital EOOD
  - Plovdiv, Plovdiv Province, Bulgarien, 4004
    - Ikke rekrutterer endnu
    - Complex Oncology Center - Plovdiv EOOD
- Sofia City Province
  - Sofia, Sofia City Province, Bulgarien, 1404
    - Rekruttering
    - Multiprofile Hospital for Active Treatment "Sveta Sofia"
  - Sofia, Sofia City Province, Bulgarien, 1797
    - Trukket tilbage
    - Specialized Hospital for Active Treatment of Oncology
  - Sofia, Sofia City Province, Bulgarien, 1797
    - Ikke rekrutterer endnu
    - University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
  - Sofia, Sofia City Province, Bulgarien, 1303
    - Aktiv, ikke rekrutterende
    - MHAT Serdikamed
- Varna Province
  - Varna, Varna Province, Bulgarien, 9010
    - Ikke rekrutterer endnu
    - MHAT Sveta Marina EAD
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Afsluttet
    - BC Cancer | Vancouver
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Rekruttering
    - Brampton Civic Hospital | Oncology
  - Toronto, Ontario, Canada, M5G 2C4
    - Rekruttering
    - Princess Margaret Cancer Centre | Medical Oncology and Hematology
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Rekruttering
    - Jewish General Hospital | Pulmonary Oncology
Danmark
- Capital Region / Region Hovedstaden
  - Copenhagen, Capital Region / Region Hovedstaden, Danmark, 2100
    - Aktiv, ikke rekrutterende
    - Rigshospitalet Copenhagen University Hospital | Oncology Department
- Central Denmark Region / Region Midtjylland
  - Aarhus N, Central Denmark Region / Region Midtjylland, Danmark, 8200
    - Afsluttet
    - Aarhus Universitetshospital
  - Herning, Central Denmark Region / Region Midtjylland, Danmark, 7400
    - Trukket tilbage
    - Regionshospitalet Gødstrup - Medicinsk afdeling
- North Denmark Region / Region Nordjylland
  - Aalborg, North Denmark Region / Region Nordjylland, Danmark, 9000
    - Trukket tilbage
    - Aalborg Universitetshospital - Onkologisk afdeling
- Region of Southern Denmark / Region Syddanmark
  - Odense, Region of Southern Denmark / Region Syddanmark, Danmark, 5000
    - Aktiv, ikke rekrutterende
    - Odense University Hospital | Svendborg Sygehus - Oncology Department
Det Forenede Kongerige
- Devon
  - Torquay, Devon, Det Forenede Kongerige, TQ2 7AA
    - Aktiv, ikke rekrutterende
    - Torbay Hospital | Oncology
- Northern Ireland
  - Belfast, Northern Ireland, Det Forenede Kongerige, BT12 7AB
    - Trukket tilbage
    - Belfast City Hospital | Oncology
- Surrey
  - Guildford, Surrey, Det Forenede Kongerige, GU2 7XX
    - Aktiv, ikke rekrutterende
    - Royal Surrey County Hospital | Cancer Centre
- Wales
  - Cardiff, Wales, Det Forenede Kongerige, CF14 2TL
    - Trukket tilbage
    - Velindre Cancer Centre | Clinical Trials Unit
Finland
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Trukket tilbage
    - Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00180
    - Trukket tilbage
    - Docrates Mehiläinen Syöpäsairaala
Forenede Stater
- California
  - Newport Beach, California, Forenede Stater, 92663
    - Trukket tilbage
    - Patty & George Hoag Cancer Center
  - San Diego, California, Forenede Stater, 92037
    - Trukket tilbage
    - UC San Diego Health - Moores Cancer Center
  - San Francisco, California, Forenede Stater, 94158
    - Rekruttering
    - UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
  - Santa Monica, California, Forenede Stater, 90404
    - Rekruttering
    - UCLA Health Santa Monica Cancer Care
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - Rekruttering
    - The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
  - Miramar, Florida, Forenede Stater, 33029
    - Trukket tilbage
    - Memorial Cancer Institute at Miramar
  - Orlando, Florida, Forenede Stater, 32804
    - Ikke rekrutterer endnu
    - AdventHealth Cancer Institute Orlando
  - Tampa, Florida, Forenede Stater, 33612
    - Trukket tilbage
    - Moffitt Cancer Center - Magnolia Campus
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30318
    - Rekruttering
    - Piedmont Healthcare - Atlanta
  - Columbus, Georgia, Forenede Stater, 31904
    - Rekruttering
    - John B. Amos Cancer Center
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - Rekruttering
    - University of Illinois Hospital - Outpatient Cancer Care Center
  - Chicago, Illinois, Forenede Stater, 60637
    - Trukket tilbage
    - The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Ikke rekrutterer endnu
    - UM Greenebaum Comprehensive Cancer Center
- Massachusetts
  - Worcester, Massachusetts, Forenede Stater, 01655
    - Trukket tilbage
    - UMass Memorial Medical Center - University Campus - Hematology/Oncology
- Michigan
  - Farmington Hills, Michigan, Forenede Stater, 48334
    - Trukket tilbage
    - Profound Research -OMG - TriAtria Cancer Center
  - Royal Oak, Michigan, Forenede Stater, 48073
    - Trukket tilbage
    - Profound Research - OMG - Royal Oak Cancer Center
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - Trukket tilbage
    - M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
- New York
  - New Hyde Park, New York, Forenede Stater, 11042
    - Trukket tilbage
    - R.J. Zuckerberg Cancer Center
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Rekruttering
    - UC Medical Center - Oncology
  - Maumee, Ohio, Forenede Stater, 43537
    - Rekruttering
    - Taylor Cancer Research Center
- Oregon
  - Portland, Oregon, Forenede Stater, 97213
    - Trukket tilbage
    - Providence Cancer Institute - Franz Clinic
  - Portland, Oregon, Forenede Stater, 97225
    - Trukket tilbage
    - Providence Oncology and Hematology Care Clinic Westside
- Pennsylvania
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Rekruttering
    - Allegheny General Hospital
- Texas
  - Dallas, Texas, Forenede Stater, 75235
    - Trukket tilbage
    - University Hospital Simmons Cancer Center Lung/Head Neck Clinic
  - Houston, Texas, Forenede Stater, 77030
    - Rekruttering
    - The University of Texas MD Anderson Cancer Center - Texas Medical Center
Frankrig
- Auvergne-Rhône-Alpes
  - La Tronche, Auvergne-Rhône-Alpes, Frankrig, 38700
    - Afsluttet
    - Centre Hospitalier Michallon Grenoble - Service pneumologie
  - Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrig, 69310
    - Aktiv, ikke rekrutterende
    - hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
- Brittany Region
  - Brest, Brittany Region, Frankrig, 29200
    - Aktiv, ikke rekrutterende
    - Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
- Grand Est
  - Mulhouse, Grand Est, Frankrig, 68100
    - Trukket tilbage
    - hopital Emile Muller - Service Pneumologie
- Hauts-de-France
  - Lille, Hauts-de-France, Frankrig, 59000
    - Aktiv, ikke rekrutterende
    - Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
- New Aquitaine
  - Bordeaux, New Aquitaine, Frankrig, 33076
    - Aktiv, ikke rekrutterende
    - Institut Bergonie - Unicancer Nouvelle Aquitaine
  - Limoges, New Aquitaine, Frankrig, 87000
    - Aktiv, ikke rekrutterende
    - Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
- Normandy
  - Rouen, Normandy, Frankrig, 76031
    - Trukket tilbage
    - CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
- Occitanie
  - Montpellier, Occitanie, Frankrig, 34091
    - Aktiv, ikke rekrutterende
    - CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, Frankrig, 44093
    - Aktiv, ikke rekrutterende
    - Hopital Nord Laennec - Oncologie medicale thoracique et digestive
  - Saint-Herblain, Pays de la Loire Region, Frankrig, 44800
    - Aktiv, ikke rekrutterende
    - Institut de Cancerologie Ouest - Saint-Herblain
- Provence-Alpes-Côte d'Azur Region
  - Nice, Provence-Alpes-Côte d'Azur Region, Frankrig, 06100
    - Aktiv, ikke rekrutterende
    - Centre Antoine Lacassagne - Departement Oncologie
- Île-de-France Region
  - Créteil, Île-de-France Region, Frankrig, 94010
    - Aktiv, ikke rekrutterende
    - Centre Hospitalier Intercommunal Creteil - Service de pneumologie
  - Paris, Île-de-France Region, Frankrig, 75014
    - Trukket tilbage
    - APHP - Hopital Cochin - Service de Pneumologie
  - Paris, Île-de-France Region, Frankrig, 75248
    - Aktiv, ikke rekrutterende
    - Institut Curie - Paris - Oncologie medicale
  - Suresnes, Île-de-France Region, Frankrig, 92150
    - Trukket tilbage
    - Hopital Foch - Oncologie digestive et thoracique
  - Villejuif, Île-de-France Region, Frankrig, 94800
    - Aktiv, ikke rekrutterende
    - Gustave Roussy - Departement Oncologie-Radiotherapie
Grækenland
- - Athens, Grækenland, 11526
    - Aktiv, ikke rekrutterende
    - Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
  - Athens, Grækenland, 11527
    - Aktiv, ikke rekrutterende
    - Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
  - Athens, Grækenland, 11528
    - Aktiv, ikke rekrutterende
    - General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
  - Athens, Grækenland, 12462
    - Aktiv, ikke rekrutterende
    - University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
  - Larissa, Grækenland, 41110
    - Trukket tilbage
    - University General Hospital Of Larissa | Medical Oncology
  - Piraeus, Grækenland, 18547
    - Trukket tilbage
    - Metropolitan Hospital- 4th Oncology Clinic
  - Pylaia Thessaloniki, Grækenland, 555 35
    - Trukket tilbage
    - Genesis Hospital- Department of Pathological Oncology
  - Thessaloniki, Grækenland, 57010
    - Aktiv, ikke rekrutterende
    - Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
- Attica
  - Chaïdári, Attica, Grækenland, 12462
    - Trukket tilbage
    - University General Hospital Attikon-4th Department of Internal Medicine
Holland
- Gelderland
  - Nijmegen, Gelderland, Holland, 6500 HB
    - Trukket tilbage
    - Radboud University Medical Center | Afdeling Interne Geneeskunde
- North Holland
  - Amsterdam, North Holland, Holland, 1066 CX
    - Aktiv, ikke rekrutterende
    - Nederlands Kanker Instituut
Hong Kong
- - Kowloon, Hong Kong, 00000
    - Aktiv, ikke rekrutterende
    - Hong Kong United Oncology Centre
- Hong Kong SAR
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Rekruttering
    - Prince of Wales Hospital
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Rekruttering
    - Queen Elizabeth Hospital Hong Kong
  - Hong Kong, Hong Kong SAR, Hong Kong, 00000
    - Ikke rekrutterer endnu
    - Queen Mary Hospital
Israel
- - Jerusalem, Israel, 91031
    - Aktiv, ikke rekrutterende
    - Shaare Zedek Medical Center - Oncology Institute
  - Tel Aviv, Israel, 6423906
    - Afsluttet
    - Tel Aviv Sourasky Medical Center - Oncology Department
- Central District
  - Ashdod, Central District, Israel, 7747629
    - Aktiv, ikke rekrutterende
    - Assuta Ashdod Public Hospital (R.A)
- Southern District
  - Beersheba, Southern District, Israel, 8410101
    - Afsluttet
    - Clalit Health | Soroka Medical Center - Oncology department
Italien
- Apulia
  - Lecce, Apulia, Italien, 73100
    - Trukket tilbage
    - Ospedale Vito Fazzi Lecce - Oncologia
- Campania
  - Avellino, Campania, Italien, 83100
    - Afsluttet
    - AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italien, 40138
    - Aktiv, ikke rekrutterende
    - Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
  - Meldola, Emilia-Romagna, Italien, 47014
    - Aktiv, ikke rekrutterende
    - Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
- Friuli Venezia Giulia
  - Aviano, Friuli Venezia Giulia, Italien, 33081
    - Aktiv, ikke rekrutterende
    - Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
- Lazio
  - Rome, Lazio, Italien, 00144
    - Aktiv, ikke rekrutterende
    - I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
  - Rome, Lazio, Italien, 00168
    - Aktiv, ikke rekrutterende
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
- Lombardy
  - Milan, Lombardy, Italien, 20132
    - Afsluttet
    - Ospedale San Raffaele s.r.l. - Oncologia Medica
  - Milan, Lombardy, Italien, 20133
    - Aktiv, ikke rekrutterende
    - Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
  - Milan, Lombardy, Italien, 20141
    - Aktiv, ikke rekrutterende
    - Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
  - Rozzano, Lombardy, Italien, 20089
    - Aktiv, ikke rekrutterende
    - Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
  - Varese, Lombardy, Italien, 21100
    - Trukket tilbage
    - ASST Sette Laghi_Ospedale Macchi - Oncologia
- Piedmont
  - Orbassano, Piedmont, Italien, 10043
    - Aktiv, ikke rekrutterende
    - Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
- Sicily
  - Palermo, Sicily, Italien, 90146
    - Aktiv, ikke rekrutterende
    - Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
- Tuscany
  - Florence, Tuscany, Italien, 50134
    - Aktiv, ikke rekrutterende
    - Careggi University Hospital - Oncologia Clinica
- Veneto
  - Padova, Veneto, Italien, 35128
    - Aktiv, ikke rekrutterende
    - Istituto Oncologico Veneto_Padova - UOC Oncologia 2
  - Verona, Veneto, Italien, 37134
    - Trukket tilbage
    - Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
Japan
- - Fukuoka, Japan, 810-8563
    - Aktiv, ikke rekrutterende
    - National Hospital Organization Kyushu Medical Center
  - Niigata, Japan, 951-8566
    - Aktiv, ikke rekrutterende
    - Niigata Cancer Center Hospital
  - Osaka, Japan, 541-8567
    - Aktiv, ikke rekrutterende
    - Osaka International Cancer Institute
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 460-0001
    - Aktiv, ikke rekrutterende
    - National Hospital Organization Nagoya Medical Center
- Chiba
  - Kashiwa, Chiba, Japan, 277-8577
    - Aktiv, ikke rekrutterende
    - National Cancer Center Hospital East
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Rekruttering
    - Hokkaido University Hospital
- Hyōgo
  - Himeji, Hyōgo, Japan, 670-8520
    - Ikke rekrutterer endnu
    - National Hospital Organization Himeji Medical Center
  - Kobe, Hyōgo, Japan, 650-0017
    - Aktiv, ikke rekrutterende
    - Kobe University Hospital
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0375
    - Aktiv, ikke rekrutterende
    - Kitasato University Hospital
- Miyagi
  - Sendai, Miyagi, Japan, 980-0873
    - Aktiv, ikke rekrutterende
    - Sendai Kousei Hospital
- Osaka
  - Hirakata, Osaka, Japan, 573-1191
    - Aktiv, ikke rekrutterende
    - Kansai Medical University Hospital
  - Sakai, Osaka, Japan, 590-0197
    - Ikke rekrutterer endnu
    - Kindai University Hospital
- Saitama
  - Kitaadachi, Saitama, Japan, 362-0806
    - Aktiv, ikke rekrutterende
    - Saitama Cancer Center
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8603
    - Ikke rekrutterer endnu
    - Nippon Medical School - Nippon Medical School Hospital - Cancer Center
- Tottori
  - Yonago, Tottori, Japan, 683-8504
    - Aktiv, ikke rekrutterende
    - Tottori University Hospital
- Yamaguchi
  - Ube, Yamaguchi, Japan, 755-0241
    - Aktiv, ikke rekrutterende
    - National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
Kina
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina, 100142
    - Aktiv, ikke rekrutterende
    - Beijing Cancer Hospital - Oncology Department
  - Beijing, Beijing Municipality, Kina, 100730
    - Aktiv, ikke rekrutterende
    - Beijing Hospital
  - Beijing, Beijing Municipality, Kina, 100853
    - Ikke rekrutterer endnu
    - The People's Liberation Army General Hospital (Beijing 301 Hospital)
  - Beijing, Beijing Municipality, Kina, 100021
    - Ikke rekrutterer endnu
    - Cancer Hospital, Chinese Academy of Medical Sciences
  - Beijing, Beijing Municipality, Kina, 101149
    - Aktiv, ikke rekrutterende
    - Beijing chest hospital, Capital Medical University
- Fujian
  - Fuzhou, Fujian, Kina, 350014
    - Aktiv, ikke rekrutterende
    - Fujian Cancer Hospital
  - Xiamen, Fujian, Kina, 361003
    - Afsluttet
    - Xiamen University - The First Affiliated Hospital
- Guangdong
  - Guangzhou, Guangdong, Kina, 510160
    - Aktiv, ikke rekrutterende
    - The first Affiliated Hospital of Guangzhou Medical University
- Guangxi
  - Nanning, Guangxi, Kina, 530021
    - Aktiv, ikke rekrutterende
    - Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
- Heilongjiang
  - Harbin, Heilongjiang, Kina, 150000
    - Trukket tilbage
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, Kina, 430079
    - Aktiv, ikke rekrutterende
    - Hubei Cancer Hospital
  - Wuhan, Hubei, Kina, 430023
    - Aktiv, ikke rekrutterende
    - Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
- Hunan
  - Changsha, Hunan, Kina, 410013
    - Aktiv, ikke rekrutterende
    - Hunan Cancer Hospital - Oncology Department
- Jiangsu
  - Nanjing, Jiangsu, Kina, 210029
    - Aktiv, ikke rekrutterende
    - Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
  - Nanjing, Jiangsu, Kina, 210008
    - Aktiv, ikke rekrutterende
    - Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
  - Taizhou, Jiangsu, Kina, 317000
    - Aktiv, ikke rekrutterende
    - Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
- Jilin
  - Changchun, Jilin, Kina, 130000
    - Aktiv, ikke rekrutterende
    - Jilin Cancer Hospital
- Shandong
  - Jinan, Shandong, Kina, 250117
    - Aktiv, ikke rekrutterende
    - Shandong University - Shandong Cancer Hospital
  - Linyi, Shandong, Kina, 276001
    - Aktiv, ikke rekrutterende
    - LinYi Cancer Hospital (Linyi Tumor Hospital)
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Kina, 200030
    - Aktiv, ikke rekrutterende
    - Shanghai Chest Hospital, Shanghai Jiaotong University
  - Shanghai, Shanghai Municipality, Kina, 200032
    - Aktiv, ikke rekrutterende
    - Zhongshan Hospital, Fudan University
- Sichuan
  - Chengdu, Sichuan, Kina, 610041
    - Aktiv, ikke rekrutterende
    - West China Hospital Sichuan University
  - Chengdu, Sichuan, Kina, 610041
    - Aktiv, ikke rekrutterende
    - University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
- Zhejiang
  - Hangzhou, Zhejiang, Kina, 310022
    - Aktiv, ikke rekrutterende
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, Kina, 310016
    - Aktiv, ikke rekrutterende
    - Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Malaysia
- Kuala Lumpur
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
    - Aktiv, ikke rekrutterende
    - Universiti Malaya Medical Centre
- Kuala Lumpur and Selangor
  - Cheras, Kuala Lumpur and Selangor, Malaysia, 56000
    - Trukket tilbage
    - University Hospital Kebangsaan Malaysia
- Pulau Pinang
  - George Town, Pulau Pinang, Malaysia, 10050
    - Ikke rekrutterer endnu
    - Gleneagles Penang Medical Center
  - Perai, Pulau Pinang, Malaysia, 13700
    - Aktiv, ikke rekrutterende
    - Sunway Medical Centre Penang
- Selangor
  - Petaling Jaya, Selangor, Malaysia, 46050
    - Ikke rekrutterer endnu
    - Beacon Hospital
  - Shah Alam, Selangor, Malaysia, 40460
    - Ikke rekrutterer endnu
    - Columbia Asia Hospital Bukit Rimau
  - Subang Jaya, Selangor, Malaysia, 47500
    - Aktiv, ikke rekrutterende
    - Sunway Medical Centre
Mexico
- - Puebla City, Mexico, 72530
    - Ikke rekrutterer endnu
    - Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
- Mexico City
  - Mexico City, Mexico City, Mexico, 14080
    - Afsluttet
    - Instituto Nacional de Cancerología
  - Mexico City, Mexico City, Mexico, 3810
    - Aktiv, ikke rekrutterende
    - Oncare Viaducto Nápoles
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Aktiv, ikke rekrutterende
    - Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
  - San Pedro Garza García, Nuevo León, Mexico, 66220
    - Aktiv, ikke rekrutterende
    - ONCARE Treatment Center
- State of Mexico
  - Naucalpan, State of Mexico, Mexico, 53100
    - Aktiv, ikke rekrutterende
    - Oncología Integral Satélite
Polen
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Polen, 60-569
    - Aktiv, ikke rekrutterende
    - Wielkopolskie Centrum Pulmonologii i Torakochirurgii
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Polen, 53-413
    - Trukket tilbage
    - Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
- Masovian Voivodeship
  - Otwock, Masovian Voivodeship, Polen, 05-400
    - Trukket tilbage
    - Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
  - Warsaw, Masovian Voivodeship, Polen, 02-781
    - Trukket tilbage
    - Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
  - Warsaw, Masovian Voivodeship, Polen, 01-138
    - Trukket tilbage
    - Instytut Gruzlicy i Chorob Pluc
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Polen, 15-276
    - Trukket tilbage
    - Uniwersytecki Szpital Kliniczny w Bialymstoku
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Polen, 92-213
    - Afsluttet
    - Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
- Świętokrzyskie Voivodeship
  - Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
    - Trukket tilbage
    - Swietokrzyskie Centrum Onkologii
Portugal
- - Lisbon, Portugal, 1769-001
    - Rekruttering
    - CHULN - Hospital Pulido Valente
  - Lisbon, Portugal, 1400-038
    - Afsluttet
    - Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
  - Porto, Portugal, 4200-072
    - Rekruttering
    - IPO Porto
- Beira Litoral
  - Coimbra, Beira Litoral, Portugal, 3004-561
    - Afsluttet
    - Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
- Porto District
  - Matosinhos Municipality, Porto District, Portugal, 4464-513
    - Rekruttering
    - Hospital Pedro Hispano | Clinical Research Center
Rumænien
- Bucharest Municipality
  - Bucharest, Bucharest Municipality, Rumænien, 22328
    - Aktiv, ikke rekrutterende
    - Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
  - Bucharest, Bucharest Municipality, Rumænien, 30171
    - Trukket tilbage
    - Spitalul Clinic Coltea
- Cluj
  - Cluj-Napoca, Cluj, Rumænien, 400015
    - Trukket tilbage
    - CardioMed S.R.L.
  - Cluj-Napoca, Cluj, Rumænien, 400015
    - Aktiv, ikke rekrutterende
    - Institutul Oncologic Prof. Dr. Ion Chiricuta
- Comuna Floresti
  - Florești, Comuna Floresti, Rumænien, 407280
    - Aktiv, ikke rekrutterende
    - Radiotherapy Center Cluj SRL
- Constanța County
  - Ovidiu, Constanța County, Rumænien, 905900
    - Trukket tilbage
    - S.C Ovidius Clinical Hospital SRL - Oncology Department
- Dolj
  - Craiova, Dolj, Rumænien, 200385
    - Trukket tilbage
    - Sc Oncolab Srl
  - Craiova, Dolj, Rumænien, 200745
    - Aktiv, ikke rekrutterende
    - Centrul de Oncologie Sfantul Nectarie
- Timiș County
  - Timișoara, Timiș County, Rumænien, 300166
    - Trukket tilbage
    - Oncocenter
Schweiz
- - Fribourg, Schweiz, 1708
    - Trukket tilbage
    - HFR Freiburg - Kantonsspital
- Canton of Aargau
  - Baden, Canton of Aargau, Schweiz, 5404
    - Aktiv, ikke rekrutterende
    - Kantonsspital Baden
Singapore
- - Singapore, Singapore, 308433
    - Afsluttet
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 168583
    - Aktiv, ikke rekrutterende
    - National Cancer Center Singapore - Oncology Department
  - Singapore, Singapore, 188770
    - Afsluttet
    - Raffles Cancer Centre
  - Singapore, Singapore, 258499
    - Aktiv, ikke rekrutterende
    - OncoCare Cancer Centre | Gleneagles Medical Centre
  - Singapore, Singapore, 329563
    - Afsluttet
    - Curie Oncology | Farrer
Slovakiet
- - Trnava, Slovakiet, 917 75
    - Afsluttet
    - Fakultna nemocnica Trnava
- Presov
  - Poprad, Presov, Slovakiet, 058 01
    - Trukket tilbage
    - POKO Poprad s.r.o.
Spanien
- - A Coruña, Spanien, 15006
    - Trukket tilbage
    - Complexo Hospitalario Universitario A Coruna | Oncologia
  - Barcelona, Spanien, 08028
    - Aktiv, ikke rekrutterende
    - Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
  - Barcelona, Spanien, 08035
    - Aktiv, ikke rekrutterende
    - Hospital Universitari Vall D Hebron | Oncologia
  - Barcelona, Spanien, 08036
    - Trukket tilbage
    - Hospital Clinic De Barcelona | Oncologia
  - Madrid, Spanien, 28034
    - Trukket tilbage
    - Hospital Universitario Ramon Y Cajal | Oncologia
  - Madrid, Spanien, 28040
    - Trukket tilbage
    - Hospital Universitario Fundacion Jimenez Diaz | Oncologia
  - Madrid, Spanien, 28009
    - Trukket tilbage
    - Hospital General Universitario Gregorio Maranon | Oncologia
  - Valencia, Spanien, 46026
    - Aktiv, ikke rekrutterende
    - Hospital Universitario Y Politecnico La Fe | Oncologia
  - Valencia, Spanien, 46009
    - Trukket tilbage
    - Fundacion Instituto Valenciano De Oncologia | Oncologia
- Barcelona
  - Badalona, Barcelona, Spanien, 08916
    - Aktiv, ikke rekrutterende
    - Hospital Germans Trias I Pujol | Oncologia
- Madrid
  - Majadahonda, Madrid, Spanien, 28222
    - Aktiv, ikke rekrutterende
    - Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
- Navarre
  - Pamplona, Navarre, Spanien, 31008
    - Aktiv, ikke rekrutterende
    - Hospital Universitario De Navarra | Oncologia
Sverige
- - Lund, Sverige, 221 85
    - Aktiv, ikke rekrutterende
    - Skånes Universitetssjukhus - Lund - Lungmedicin
- Västerbotten County
  - Umeå, Västerbotten County, Sverige, 901 85
    - Afsluttet
    - Norrlands Universitetssjukhus Umeå - Cancercentrum
Sydkorea
- - Seoul, Sydkorea, 03722
    - Rekruttering
    - Severance Hospital | Oncology
  - Seoul, Sydkorea, 06351
    - Rekruttering
    - Samsung Medical Center | Oncology
- Gyeonggi-do
  - Suwon, Gyeonggi-do, Sydkorea, 16247
    - Ikke rekrutterer endnu
    - St Vincent's Hospital | Oncology
- Gyeongsangnam-do
  - Jinju, Gyeongsangnam-do, Sydkorea, 52727
    - Ikke rekrutterer endnu
    - Gyeongsang National University Hospital | Oncology
  - Yangsan, Gyeongsangnam-do, Sydkorea, 50612
    - Afsluttet
    - Pusan National University Yangsan Hospital | Pulmonology
- Jeollanam-do
  - Hwasun-gun, Jeollanam-do, Sydkorea, 58128
    - Ikke rekrutterer endnu
    - Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
- North Chungcheong
  - Chungcheongbuk-do, North Chungcheong, Sydkorea, 28644
    - Ikke rekrutterer endnu
    - Chungbuk National University Hospital | Hematology and Oncology
- Seoul
  - Jongno -Gu, Seoul, Sydkorea, 03080
    - Rekruttering
    - Seoul National University Hospital | Oncology
Taiwan
- - Kaohsiung City, Taiwan, 807377
    - Afsluttet
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 40705
    - Rekruttering
    - Taichung Veterans General Hospital
  - Taichung, Taiwan, 402306
    - Aktiv, ikke rekrutterende
    - Chung Shan Medical University Hospital
  - Tainan, Taiwan, 704
    - Aktiv, ikke rekrutterende
    - National Cheng Kung University Hospital
  - Tainan, Taiwan, 73657
    - Afsluttet
    - Chi-Mei Medical Center, Liouyine
  - Taipei, Taiwan, 100
    - Rekruttering
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Aktiv, ikke rekrutterende
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 100225
    - Rekruttering
    - National Taiwan University Hospital (NTUH) - Cancer Research Center
Tjekkiet
- Moravian-Silesian Region
  - Nový Jičín, Moravian-Silesian Region, Tjekkiet, 741 01
    - Trukket tilbage
    - Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
  - Ostrava - Vítkovice, Moravian-Silesian Region, Tjekkiet, 703 00
    - Trukket tilbage
    - Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
- Olomouc Region
  - Olomouc, Olomouc Region, Tjekkiet, 779 00
    - Trukket tilbage
    - Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
- South Moravian
  - Brno, South Moravian, Tjekkiet, 602 00
    - Rekruttering
    - Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
- Zlín
  - Zlín, Zlín, Tjekkiet, 762 75
    - Trukket tilbage
    - Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
Tyrkiet (Türkiye)
- - Istanbul, Tyrkiet (Türkiye), 34899
    - Afsluttet
    - Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  - Izmir, Tyrkiet (Türkiye), 35100
    - Aktiv, ikke rekrutterende
    - Ege Universitesi Tip Fakultesi Hastanesi
  - Sakarya, Tyrkiet (Türkiye), 54100
    - Ikke rekrutterer endnu
    - Sakarya Universitesi Egitim ve Arastirma Hastanesi
- Adana
  - Yüreğir, Adana, Tyrkiet (Türkiye), 1370
    - Afsluttet
    - Adana Sehir Egitim ve Arastirma Hastanesi
- Aksaray
  - Bilkent Ankara, Aksaray, Tyrkiet (Türkiye), 6800
    - Aktiv, ikke rekrutterende
    - Ankara Bilkent Sehir Hastanesi
- Ankara
  - Yenimahalle, Ankara, Tyrkiet (Türkiye), 6170
    - Ikke rekrutterer endnu
    - Ankara Etlik Sehir Hastanesi
- Istanbul
  - Kadıköy, Istanbul, Tyrkiet (Türkiye), 34722
    - Aktiv, ikke rekrutterende
    - İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
  - Küçükçekmece, Istanbul, Tyrkiet (Türkiye), 34295
    - Ikke rekrutterer endnu
    - İ.A.Ü. VM Medical Park Florya Hastanesi
Tyskland
- - Berlin, Tyskland, 12203
    - Ikke rekrutterer endnu
    - Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
- Baden-Wurttemberg
  - Stuttgart, Baden-Wurttemberg, Tyskland, 70376
    - Afsluttet
    - Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
- Bavaria
  - Nuremberg, Bavaria, Tyskland, 90419
    - Aktiv, ikke rekrutterende
    - Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
- Hesse
  - Frankfurt am Main, Hesse, Tyskland, 60590
    - Ikke rekrutterer endnu
    - Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
  - Giessen, Hesse, Tyskland, 35392
    - Ikke rekrutterer endnu
    - Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Tyskland, 51109
    - Aktiv, ikke rekrutterende
    - Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
  - Essen, North Rhine-Westphalia, Tyskland, 45147
    - Aktiv, ikke rekrutterende
    - Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
  - Hemer, North Rhine-Westphalia, Tyskland, 58675
    - Aktiv, ikke rekrutterende
    - Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
Ukraine
- Dnipropetrovsk Oblast
  - Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
    - Ikke rekrutterer endnu
    - LLC "RDP Ukraine" - Medical Department
- Kirovohrad Oblast
  - Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
    - Ikke rekrutterer endnu
    - Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
- Kyiv City
  - Kyiv, Kyiv City, Ukraine, 03115
    - Ikke rekrutterer endnu
    - Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
  - Kyiv, Kyiv City, Ukraine, 03189
    - Aktiv, ikke rekrutterende
    - Limited Liability Company "MedOffice Group Medical Center"
  - Kyiv, Kyiv City, Ukraine, 3039
    - Ikke rekrutterer endnu
    - Medical Center LLC "Verum Expert Clinic"
- Rivne Oblast
  - Rivne, Rivne Oblast, Ukraine, 33010
    - Aktiv, ikke rekrutterende
    - Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
- Volyn Oblast
  - Lutsk, Volyn Oblast, Ukraine, 43018
    - Ikke rekrutterer endnu
    - Regional Medical Oncology Centre_Oncology Chemotherapy Department
- Zakarpattia Oblast
  - Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
    - Ikke rekrutterer endnu
    - MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
Ungarn
- - Budapest, Ungarn, 1145
    - Trukket tilbage
    - Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
- Komárom-Esztergom
  - Tatabánya, Komárom-Esztergom, Ungarn, 2800
    - Trukket tilbage
    - Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Østrig
- - Vienna, Østrig, 1210
    - Aktiv, ikke rekrutterende
    - Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
- State of Salzburg
  - Vienna, State of Salzburg, Østrig, 1090
    - Trukket tilbage
    - Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
  - Vienna, State of Salzburg, Østrig, 1090
    - Trukket tilbage
    - Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
- State of Vienna
  - Vienna, State of Vienna, Østrig, 1090
    - Trukket tilbage
    - Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Sevabertinib Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.	Medicin: Sevabertinib Tablet, oral
Aktiv komparator: Standard of care (SoC) Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.	Medicin: Pembrolizumab Intravenous (IV) infusion Medicin: Cisplatin IV infusion Medicin: Carboplatin IV infusion Medicin: Pemetrexed IV infusion

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Sevabertinib

Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.

Medicin: Sevabertinib

Tablet, oral

Aktiv komparator: Standard of care (SoC)

Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.

Medicin: Pembrolizumab

Intravenous (IV) infusion

Medicin: Cisplatin

IV infusion

Medicin: Carboplatin

IV infusion

Medicin: Pemetrexed

IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR Tidsramme: Up to approximately 2 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 2 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Varighed af respons (DOR) som vurderet af investigator Tidsramme: Op til cirka 4 år		Op til cirka 4 år
Samlet overlevelse (OS) Tidsramme: Op til cirka 4 år.		Op til cirka 4 år.
Objektiv svarprocent (ORR) pr. RECIST 1.1 som vurderet af efterforskeren Tidsramme: Op til cirka 4 år		Op til cirka 4 år
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR Tidsramme: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator Tidsramme: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR Tidsramme: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator Tidsramme: Up to approximately 4 years	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Duration of response (DOR) as assessed by BICR Tidsramme: Up to approximately 4 years	BICR = blinded independent central review (BICR)	Up to approximately 4 years
Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity Tidsramme: Up to approximately 4 years	CTCAE = common terminology criteria for adverse events; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event	Up to approximately 4 years
Change from baseline in NSCLC-SAQ total score Tidsramme: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Change from baseline in NSCLC-SAQ individual domain scores Tidsramme: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Time to deterioration in NSCLC-SAQ total score Tidsramme: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Time to deterioration in NSCLC-SAQ individual domain scores Tidsramme: Up to approximately 4 years	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Time to deterioration in EORTC QLQ-C30 physical functioning domain score Tidsramme: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30	Up to approximately 4 years
Change from baseline in EORTC QLQ-C30 physical functioning domain score Tidsramme: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years
Change from baseline in EORTC QLQ-C30 global health status/QoL Tidsramme: Up to approximately 4 years	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2024

Primær færdiggørelse (Anslået)

28. oktober 2027

Studieafslutning (Anslået)

27. juni 2029

Datoer for studieregistrering

Først indsendt

5. juni 2024

Først indsendt, der opfyldte QC-kriterier

5. juni 2024

Først opslået (Faktiske)

11. juni 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

15. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

22615
2024-511319-91-00 (Anden identifikator: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

En undersøgelse for at lære mere om, hvor godt BAY 2927088 virker, og hvor sikker den er sammenlignet med standardbehandling, hos deltagere, der har avanceret ikke-småcellet lungekræft (NSCLC) med mutationer i generne af Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Udvidet adgang

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt