En studie för att lära dig mer om hur bra BAY 2927088 fungerar och hur säker den är jämfört med standardbehandling, hos deltagare som har avancerad icke-småcellig lungcancer (NSCLC) med mutationer i generna hos Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)
3 november 2026 uppdaterad av: Bayer
En fas 3 öppen, randomiserad, aktivkontrollerad, multicenterstudie för att utvärdera effektiviteten och säkerheten av oralt administrerad BAY 2927088 jämfört med standardbehandling som förstahandsterapi hos patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer (NSCLC) Med HER2-aktiverande 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
444
Fas
- Fas 3
Utökad åtkomst
Tillgängligt utanför den kliniska prövningen.
Se utökad åtkomstpost.
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Bayer Clinical Trials Contact
- Telefonnummer: 18888422937
- E-post: clinical-trials-contact@bayer.com
Studieorter
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Buenos Aires, Argentina, C1199ABB
- Indragen
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1431FWO
- Indragen
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
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Buenos Aires, Argentina, C1125 ABD
- Indragen
- Fundación Cenit para la Investigación en Neurociencias
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Córdoba, Argentina, X5008HHW
- Indragen
- Centro Médico Privado CEMAIC
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Buenos Aires
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TBC, Buenos Aires, Argentina, B1841
- Indragen
- Instituto Argentino de Diagnostico y Tratamiento (IADT)
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Río Negro Province
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Viedma, Río Negro Province, Argentina, R8500ACE
- Indragen
- Centro de Investigaciones Clínicas, Clínica Viedma
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New South Wales
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Blacktown, New South Wales, Australien, 2148
- Aktiv, inte rekryterande
- NSW Health - Blacktown Hospital
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Concord, New South Wales, Australien, 2139
- Avslutad
- Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
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Waratah, New South Wales, Australien, 2298
- Aktiv, inte rekryterande
- Calvary Mater Hospital Newcastle - Oncology
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Queensland
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Buderim, Queensland, Australien, 4556
- Indragen
- University of the Sunshine Coast
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Toowoomba, Queensland, Australien, 4350
- Indragen
- Toowoomba Hospital Oncology Clinical Trials
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Aktiv, inte rekryterande
- Austin Hospital - Olivia Newton John Cancer Research Institute
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-
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Antwerp
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Antwerp, Antwerp, Belgien, 2650
- Indragen
- Antwerp University Hospital | Oncology Department
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Flemish Brabant
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Leuven, Flemish Brabant, Belgien, 3000
- Aktiv, inte rekryterande
- UZ Leuven Gasthuisberg - Pneumology Department
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West Flanders
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Roeselare, West Flanders, Belgien, 8800
- Aktiv, inte rekryterande
- AZ Delta | Clinical Trial Center - Pneumology
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São Paulo, Brasilien, 01323-030
- Rekrytering
- A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
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São Paulo, Brasilien, 90020-090
- Rekrytering
- Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
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São Paulo, Brasilien, 01308-050
- Rekrytering
- Hospital Sirio Libanes
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São Paulo, Brasilien, 71635-610
- Indragen
- Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
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Ceará
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Fortaleza, Ceará, Brasilien, 60810-180
- Rekrytering
- Pronutrir Fortaleza - CE
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Federal District
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Brasília, Federal District, Brasilien, 04538-132
- Rekrytering
- Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
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Pernambuco
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Recife, Pernambuco, Brasilien, 50070-480
- Rekrytering
- Rede DoR Recife - PE
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59040-000
- Rekrytering
- Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
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Santa Catarina
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Blumenau, Santa Catarina, Brasilien, 89010-340
- Rekrytering
- Centro de Pesquisa da Clínica de Oncologia Reichow
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São Paulo
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Bauru, São Paulo, Brasilien, 17033-490
- Rekrytering
- NAIC - Instituto do Cancer
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Jaú, São Paulo, Brasilien, 14784-400
- Rekrytering
- Fundacao Pio XII - Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Indragen
- Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
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Pazardzhik Province
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Panagyurishte, Pazardzhik Province, Bulgarien, 4500
- Har inte rekryterat ännu
- MHAT Uni Hospital
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Pleven Province
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Pleven, Pleven Province, Bulgarien, 5804
- Har inte rekryterat ännu
- MHAT "Heart and brain" Pleven
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgarien, 4109
- Indragen
- MHAT Park Hospital EOOD
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Plovdiv, Plovdiv Province, Bulgarien, 4004
- Har inte rekryterat ännu
- Complex Oncology Center - Plovdiv EOOD
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Sofia City Province
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Sofia, Sofia City Province, Bulgarien, 1404
- Rekrytering
- Multiprofile Hospital for Active Treatment "Sveta Sofia"
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Sofia, Sofia City Province, Bulgarien, 1797
- Indragen
- Specialized Hospital for Active Treatment of Oncology
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Sofia, Sofia City Province, Bulgarien, 1797
- Har inte rekryterat ännu
- University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
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Sofia, Sofia City Province, Bulgarien, 1303
- Aktiv, inte rekryterande
- MHAT Serdikamed
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Varna Province
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Varna, Varna Province, Bulgarien, 9010
- Har inte rekryterat ännu
- MHAT Sveta Marina EAD
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Capital Region / Region Hovedstaden
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Copenhagen, Capital Region / Region Hovedstaden, Danmark, 2100
- Aktiv, inte rekryterande
- Rigshospitalet Copenhagen University Hospital | Oncology Department
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Central Denmark Region / Region Midtjylland
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Aarhus N, Central Denmark Region / Region Midtjylland, Danmark, 8200
- Avslutad
- Aarhus Universitetshospital
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Herning, Central Denmark Region / Region Midtjylland, Danmark, 7400
- Indragen
- Regionshospitalet Gødstrup - Medicinsk afdeling
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North Denmark Region / Region Nordjylland
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Aalborg, North Denmark Region / Region Nordjylland, Danmark, 9000
- Indragen
- Aalborg Universitetshospital - Onkologisk afdeling
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Region of Southern Denmark / Region Syddanmark
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Odense, Region of Southern Denmark / Region Syddanmark, Danmark, 5000
- Aktiv, inte rekryterande
- Odense University Hospital | Svendborg Sygehus - Oncology Department
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
- Indragen
- Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
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Uusimaa
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Helsinki, Uusimaa, Finland, 00180
- Indragen
- Docrates Mehiläinen Syöpäsairaala
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Auvergne-Rhône-Alpes
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La Tronche, Auvergne-Rhône-Alpes, Frankrike, 38700
- Avslutad
- Centre Hospitalier Michallon Grenoble - Service pneumologie
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Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrike, 69310
- Aktiv, inte rekryterande
- hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique
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Brittany Region
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Brest, Brittany Region, Frankrike, 29200
- Aktiv, inte rekryterande
- Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
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Grand Est
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Mulhouse, Grand Est, Frankrike, 68100
- Indragen
- hopital Emile Muller - Service Pneumologie
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Hauts-de-France
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Lille, Hauts-de-France, Frankrike, 59000
- Aktiv, inte rekryterande
- Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire
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New Aquitaine
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Bordeaux, New Aquitaine, Frankrike, 33076
- Aktiv, inte rekryterande
- Institut Bergonie - Unicancer Nouvelle Aquitaine
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Limoges, New Aquitaine, Frankrike, 87000
- Aktiv, inte rekryterande
- Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
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Normandy
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Rouen, Normandy, Frankrike, 76031
- Indragen
- CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
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Occitanie
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Montpellier, Occitanie, Frankrike, 34091
- Aktiv, inte rekryterande
- CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrike, 44093
- Aktiv, inte rekryterande
- Hopital Nord Laennec - Oncologie medicale thoracique et digestive
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Saint-Herblain, Pays de la Loire Region, Frankrike, 44800
- Aktiv, inte rekryterande
- Institut de Cancerologie Ouest - Saint-Herblain
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Provence-Alpes-Côte d'Azur Region
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Nice, Provence-Alpes-Côte d'Azur Region, Frankrike, 06100
- Aktiv, inte rekryterande
- Centre Antoine Lacassagne - Departement Oncologie
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Île-de-France Region
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Créteil, Île-de-France Region, Frankrike, 94010
- Aktiv, inte rekryterande
- Centre Hospitalier Intercommunal Creteil - Service de pneumologie
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Paris, Île-de-France Region, Frankrike, 75014
- Indragen
- APHP - Hopital Cochin - Service de Pneumologie
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Paris, Île-de-France Region, Frankrike, 75248
- Aktiv, inte rekryterande
- Institut Curie - Paris - Oncologie medicale
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Suresnes, Île-de-France Region, Frankrike, 92150
- Indragen
- Hopital Foch - Oncologie digestive et thoracique
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Villejuif, Île-de-France Region, Frankrike, 94800
- Aktiv, inte rekryterande
- Gustave Roussy - Departement Oncologie-Radiotherapie
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California
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Newport Beach, California, Förenta staterna, 92663
- Indragen
- Patty & George Hoag Cancer Center
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San Diego, California, Förenta staterna, 92037
- Indragen
- UC San Diego Health - Moores Cancer Center
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San Francisco, California, Förenta staterna, 94158
- Rekrytering
- UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
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Santa Monica, California, Förenta staterna, 90404
- Rekrytering
- UCLA Health Santa Monica Cancer Care
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Florida
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Fort Lauderdale, Florida, Förenta staterna, 33316
- Rekrytering
- The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
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Miramar, Florida, Förenta staterna, 33029
- Indragen
- Memorial Cancer Institute at Miramar
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Orlando, Florida, Förenta staterna, 32804
- Har inte rekryterat ännu
- AdventHealth Cancer Institute Orlando
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Tampa, Florida, Förenta staterna, 33612
- Indragen
- Moffitt Cancer Center - Magnolia Campus
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Georgia
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Atlanta, Georgia, Förenta staterna, 30318
- Rekrytering
- Piedmont Healthcare - Atlanta
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Columbus, Georgia, Förenta staterna, 31904
- Rekrytering
- John B. Amos Cancer Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- University of Illinois Hospital - Outpatient Cancer Care Center
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Chicago, Illinois, Förenta staterna, 60637
- Indragen
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Har inte rekryterat ännu
- UM Greenebaum Comprehensive Cancer Center
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Massachusetts
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Worcester, Massachusetts, Förenta staterna, 01655
- Indragen
- UMass Memorial Medical Center - University Campus - Hematology/Oncology
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Michigan
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Farmington Hills, Michigan, Förenta staterna, 48334
- Indragen
- Profound Research -OMG - TriAtria Cancer Center
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Royal Oak, Michigan, Förenta staterna, 48073
- Indragen
- Profound Research - OMG - Royal Oak Cancer Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- Indragen
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
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New York
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New Hyde Park, New York, Förenta staterna, 11042
- Indragen
- R.J. Zuckerberg Cancer Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- UC Medical Center - Oncology
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Maumee, Ohio, Förenta staterna, 43537
- Rekrytering
- Taylor Cancer Research Center
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Oregon
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Portland, Oregon, Förenta staterna, 97213
- Indragen
- Providence Cancer Institute - Franz Clinic
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Portland, Oregon, Förenta staterna, 97225
- Indragen
- Providence Oncology and Hematology Care Clinic Westside
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Rekrytering
- Allegheny General Hospital
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Texas
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Dallas, Texas, Förenta staterna, 75235
- Indragen
- University Hospital Simmons Cancer Center Lung/Head Neck Clinic
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- The University of Texas MD Anderson Cancer Center - Texas Medical Center
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Athens, Grekland, 11526
- Aktiv, inte rekryterande
- Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
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Athens, Grekland, 11527
- Aktiv, inte rekryterande
- Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
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Athens, Grekland, 11528
- Aktiv, inte rekryterande
- General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
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Athens, Grekland, 12462
- Aktiv, inte rekryterande
- University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
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Larissa, Grekland, 41110
- Indragen
- University General Hospital Of Larissa | Medical Oncology
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Piraeus, Grekland, 18547
- Indragen
- Metropolitan Hospital- 4th Oncology Clinic
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Pylaia Thessaloniki, Grekland, 555 35
- Indragen
- Genesis Hospital- Department of Pathological Oncology
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Thessaloniki, Grekland, 57010
- Aktiv, inte rekryterande
- Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
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Attica
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Chaïdári, Attica, Grekland, 12462
- Indragen
- University General Hospital Attikon-4th Department of Internal Medicine
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-
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Kowloon, Hong Kong, 00000
- Aktiv, inte rekryterande
- Hong Kong United Oncology Centre
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Rekrytering
- Prince of Wales Hospital
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Rekrytering
- Queen Elizabeth Hospital Hong Kong
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Har inte rekryterat ännu
- Queen Mary Hospital
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-
-
-
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Jerusalem, Israel, 91031
- Aktiv, inte rekryterande
- Shaare Zedek Medical Center - Oncology Institute
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Tel Aviv, Israel, 6423906
- Avslutad
- Tel Aviv Sourasky Medical Center - Oncology Department
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Central District
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Ashdod, Central District, Israel, 7747629
- Aktiv, inte rekryterande
- Assuta Ashdod Public Hospital (R.A)
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Southern District
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Beersheba, Southern District, Israel, 8410101
- Avslutad
- Clalit Health | Soroka Medical Center - Oncology department
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-
-
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Apulia
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Lecce, Apulia, Italien, 73100
- Indragen
- Ospedale Vito Fazzi Lecce - Oncologia
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Campania
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Avellino, Campania, Italien, 83100
- Avslutad
- AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 40138
- Aktiv, inte rekryterande
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
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Meldola, Emilia-Romagna, Italien, 47014
- Aktiv, inte rekryterande
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica
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Friuli Venezia Giulia
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Aviano, Friuli Venezia Giulia, Italien, 33081
- Aktiv, inte rekryterande
- Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
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Lazio
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Rome, Lazio, Italien, 00144
- Aktiv, inte rekryterande
- I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
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Rome, Lazio, Italien, 00168
- Aktiv, inte rekryterande
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
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Lombardy
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Milan, Lombardy, Italien, 20132
- Avslutad
- Ospedale San Raffaele s.r.l. - Oncologia Medica
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Milan, Lombardy, Italien, 20133
- Aktiv, inte rekryterande
- Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
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Milan, Lombardy, Italien, 20141
- Aktiv, inte rekryterande
- Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
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Rozzano, Lombardy, Italien, 20089
- Aktiv, inte rekryterande
- Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
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Varese, Lombardy, Italien, 21100
- Indragen
- ASST Sette Laghi_Ospedale Macchi - Oncologia
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Piedmont
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Orbassano, Piedmont, Italien, 10043
- Aktiv, inte rekryterande
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
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Sicily
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Palermo, Sicily, Italien, 90146
- Aktiv, inte rekryterande
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
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-
Tuscany
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Florence, Tuscany, Italien, 50134
- Aktiv, inte rekryterande
- Careggi University Hospital - Oncologia Clinica
-
-
Veneto
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Padova, Veneto, Italien, 35128
- Aktiv, inte rekryterande
- Istituto Oncologico Veneto_Padova - UOC Oncologia 2
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Verona, Veneto, Italien, 37134
- Indragen
- Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
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-
-
-
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Fukuoka, Japan, 810-8563
- Aktiv, inte rekryterande
- National Hospital Organization Kyushu Medical Center
-
Niigata, Japan, 951-8566
- Aktiv, inte rekryterande
- Niigata Cancer Center Hospital
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Osaka, Japan, 541-8567
- Aktiv, inte rekryterande
- Osaka International Cancer Institute
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Aichi-ken
-
Nagoya, Aichi-ken, Japan, 460-0001
- Aktiv, inte rekryterande
- National Hospital Organization Nagoya Medical Center
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Aktiv, inte rekryterande
- National Cancer Center Hospital East
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Rekrytering
- Hokkaido University Hospital
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Hyōgo
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Himeji, Hyōgo, Japan, 670-8520
- Har inte rekryterat ännu
- National Hospital Organization Himeji Medical Center
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Kobe, Hyōgo, Japan, 650-0017
- Aktiv, inte rekryterande
- Kobe University Hospital
-
-
Kanagawa
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Sagamihara, Kanagawa, Japan, 252-0375
- Aktiv, inte rekryterande
- Kitasato University Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-0873
- Aktiv, inte rekryterande
- Sendai Kousei Hospital
-
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Aktiv, inte rekryterande
- Kansai Medical University Hospital
-
Sakai, Osaka, Japan, 590-0197
- Har inte rekryterat ännu
- Kindai University Hospital
-
-
Saitama
-
Kitaadachi, Saitama, Japan, 362-0806
- Aktiv, inte rekryterande
- Saitama Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8603
- Har inte rekryterat ännu
- Nippon Medical School - Nippon Medical School Hospital - Cancer Center
-
-
Tottori
-
Yonago, Tottori, Japan, 683-8504
- Aktiv, inte rekryterande
- Tottori University Hospital
-
-
Yamaguchi
-
Ube, Yamaguchi, Japan, 755-0241
- Aktiv, inte rekryterande
- National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)
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-
-
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British Columbia
-
Vancouver, British Columbia, Kanada, V5Z 4E6
- Avslutad
- BC Cancer | Vancouver
-
-
Ontario
-
Brampton, Ontario, Kanada, L6R 3J7
- Rekrytering
- Brampton Civic Hospital | Oncology
-
Toronto, Ontario, Kanada, M5G 2C4
- Rekrytering
- Princess Margaret Cancer Centre | Medical Oncology and Hematology
-
-
Quebec
-
Montreal, Quebec, Kanada, H3T 1E2
- Rekrytering
- Jewish General Hospital | Pulmonary Oncology
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Aktiv, inte rekryterande
- Beijing Cancer Hospital - Oncology Department
-
Beijing, Beijing Municipality, Kina, 100730
- Aktiv, inte rekryterande
- Beijing Hospital
-
Beijing, Beijing Municipality, Kina, 100853
- Har inte rekryterat ännu
- The People's Liberation Army General Hospital (Beijing 301 Hospital)
-
Beijing, Beijing Municipality, Kina, 100021
- Har inte rekryterat ännu
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Beijing, Beijing Municipality, Kina, 101149
- Aktiv, inte rekryterande
- Beijing chest hospital, Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Aktiv, inte rekryterande
- Fujian Cancer Hospital
-
Xiamen, Fujian, Kina, 361003
- Avslutad
- Xiamen University - The First Affiliated Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510160
- Aktiv, inte rekryterande
- The first Affiliated Hospital of Guangzhou Medical University
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530021
- Aktiv, inte rekryterande
- Guangxi Medical University (GXMU) - Affiliated Tumor Hospital
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150000
- Indragen
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina, 430079
- Aktiv, inte rekryterande
- Hubei Cancer Hospital
-
Wuhan, Hubei, Kina, 430023
- Aktiv, inte rekryterande
- Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Aktiv, inte rekryterande
- Hunan Cancer Hospital - Oncology Department
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Aktiv, inte rekryterande
- Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
-
Nanjing, Jiangsu, Kina, 210008
- Aktiv, inte rekryterande
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
-
Taizhou, Jiangsu, Kina, 317000
- Aktiv, inte rekryterande
- Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
-
-
Jilin
-
Changchun, Jilin, Kina, 130000
- Aktiv, inte rekryterande
- Jilin Cancer Hospital
-
-
Shandong
-
Jinan, Shandong, Kina, 250117
- Aktiv, inte rekryterande
- Shandong University - Shandong Cancer Hospital
-
Linyi, Shandong, Kina, 276001
- Aktiv, inte rekryterande
- LinYi Cancer Hospital (Linyi Tumor Hospital)
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200030
- Aktiv, inte rekryterande
- Shanghai Chest Hospital, Shanghai Jiaotong University
-
Shanghai, Shanghai Municipality, Kina, 200032
- Aktiv, inte rekryterande
- Zhongshan Hospital, Fudan University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Aktiv, inte rekryterande
- West China Hospital Sichuan University
-
Chengdu, Sichuan, Kina, 610041
- Aktiv, inte rekryterande
- University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310022
- Aktiv, inte rekryterande
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, Kina, 310016
- Aktiv, inte rekryterande
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
-
-
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Aktiv, inte rekryterande
- Universiti Malaya Medical Centre
-
-
Kuala Lumpur and Selangor
-
Cheras, Kuala Lumpur and Selangor, Malaysia, 56000
- Indragen
- University Hospital Kebangsaan Malaysia
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Malaysia, 10050
- Har inte rekryterat ännu
- Gleneagles Penang Medical Center
-
Perai, Pulau Pinang, Malaysia, 13700
- Aktiv, inte rekryterande
- Sunway Medical Centre Penang
-
-
Selangor
-
Petaling Jaya, Selangor, Malaysia, 46050
- Har inte rekryterat ännu
- Beacon Hospital
-
Shah Alam, Selangor, Malaysia, 40460
- Har inte rekryterat ännu
- Columbia Asia Hospital Bukit Rimau
-
Subang Jaya, Selangor, Malaysia, 47500
- Aktiv, inte rekryterande
- Sunway Medical Centre
-
-
-
-
-
Puebla City, Mexiko, 72530
- Har inte rekryterat ännu
- Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
-
-
Mexico City
-
Mexico City, Mexico City, Mexiko, 14080
- Avslutad
- Instituto Nacional de Cancerología
-
Mexico City, Mexico City, Mexiko, 3810
- Aktiv, inte rekryterande
- Oncare Viaducto Nápoles
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexiko, 64460
- Aktiv, inte rekryterande
- Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
-
San Pedro Garza García, Nuevo León, Mexiko, 66220
- Aktiv, inte rekryterande
- ONCARE Treatment Center
-
-
State of Mexico
-
Naucalpan, State of Mexico, Mexiko, 53100
- Aktiv, inte rekryterande
- Oncología Integral Satélite
-
-
-
-
Gelderland
-
Nijmegen, Gelderland, Nederländerna, 6500 HB
- Indragen
- Radboud University Medical Center | Afdeling Interne Geneeskunde
-
-
North Holland
-
Amsterdam, North Holland, Nederländerna, 1066 CX
- Aktiv, inte rekryterande
- Nederlands Kanker Instituut
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-569
- Aktiv, inte rekryterande
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 53-413
- Indragen
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
Masovian Voivodeship
-
Otwock, Masovian Voivodeship, Polen, 05-400
- Indragen
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Indragen
- Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
-
Warsaw, Masovian Voivodeship, Polen, 01-138
- Indragen
- Instytut Gruzlicy i Chorob Pluc
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-276
- Indragen
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 92-213
- Avslutad
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
-
-
Świętokrzyskie Voivodeship
-
Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
- Indragen
- Swietokrzyskie Centrum Onkologii
-
-
-
-
-
Lisbon, Portugal, 1769-001
- Rekrytering
- CHULN - Hospital Pulido Valente
-
Lisbon, Portugal, 1400-038
- Avslutad
- Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
-
Porto, Portugal, 4200-072
- Rekrytering
- IPO Porto
-
-
Beira Litoral
-
Coimbra, Beira Litoral, Portugal, 3004-561
- Avslutad
- 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
- Rekrytering
- Hospital Pedro Hispano | Clinical Research Center
-
-
-
-
Bucharest Municipality
-
Bucharest, Bucharest Municipality, Rumänien, 22328
- Aktiv, inte rekryterande
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
-
Bucharest, Bucharest Municipality, Rumänien, 30171
- Indragen
- Spitalul Clinic Coltea
-
-
Cluj
-
Cluj-Napoca, Cluj, Rumänien, 400015
- Indragen
- CardioMed S.R.L.
-
Cluj-Napoca, Cluj, Rumänien, 400015
- Aktiv, inte rekryterande
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
-
Comuna Floresti
-
Florești, Comuna Floresti, Rumänien, 407280
- Aktiv, inte rekryterande
- Radiotherapy Center Cluj SRL
-
-
Constanța County
-
Ovidiu, Constanța County, Rumänien, 905900
- Indragen
- S.C Ovidius Clinical Hospital SRL - Oncology Department
-
-
Dolj
-
Craiova, Dolj, Rumänien, 200385
- Indragen
- Sc Oncolab Srl
-
Craiova, Dolj, Rumänien, 200745
- Aktiv, inte rekryterande
- Centrul de Oncologie Sfantul Nectarie
-
-
Timiș County
-
Timișoara, Timiș County, Rumänien, 300166
- Indragen
- Oncocenter
-
-
-
-
-
Fribourg, Schweiz, 1708
- Indragen
- HFR Freiburg - Kantonsspital
-
-
Canton of Aargau
-
Baden, Canton of Aargau, Schweiz, 5404
- Aktiv, inte rekryterande
- Kantonsspital Baden
-
-
-
-
-
Singapore, Singapore, 308433
- Avslutad
- Tan Tock Seng Hospital
-
Singapore, Singapore, 168583
- Aktiv, inte rekryterande
- National Cancer Center Singapore - Oncology Department
-
Singapore, Singapore, 188770
- Avslutad
- Raffles Cancer Centre
-
Singapore, Singapore, 258499
- Aktiv, inte rekryterande
- OncoCare Cancer Centre | Gleneagles Medical Centre
-
Singapore, Singapore, 329563
- Avslutad
- Curie Oncology | Farrer
-
-
-
-
-
Trnava, Slovakien, 917 75
- Avslutad
- Fakultna nemocnica Trnava
-
-
Presov
-
Poprad, Presov, Slovakien, 058 01
- Indragen
- POKO Poprad s.r.o.
-
-
-
-
-
A Coruña, Spanien, 15006
- Indragen
- Complexo Hospitalario Universitario A Coruna | Oncologia
-
Barcelona, Spanien, 08028
- Aktiv, inte rekryterande
- Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
-
Barcelona, Spanien, 08035
- Aktiv, inte rekryterande
- Hospital Universitari Vall D Hebron | Oncologia
-
Barcelona, Spanien, 08036
- Indragen
- Hospital Clinic De Barcelona | Oncologia
-
Madrid, Spanien, 28034
- Indragen
- Hospital Universitario Ramon Y Cajal | Oncologia
-
Madrid, Spanien, 28040
- Indragen
- Hospital Universitario Fundacion Jimenez Diaz | Oncologia
-
Madrid, Spanien, 28009
- Indragen
- Hospital General Universitario Gregorio Maranon | Oncologia
-
Valencia, Spanien, 46026
- Aktiv, inte rekryterande
- Hospital Universitario Y Politecnico La Fe | Oncologia
-
Valencia, Spanien, 46009
- Indragen
- Fundacion Instituto Valenciano De Oncologia | Oncologia
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Aktiv, inte rekryterande
- Hospital Germans Trias I Pujol | Oncologia
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Aktiv, inte rekryterande
- Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Aktiv, inte rekryterande
- Hospital Universitario De Navarra | Oncologia
-
-
-
-
Devon
-
Torquay, Devon, Storbritannien, TQ2 7AA
- Aktiv, inte rekryterande
- Torbay Hospital | Oncology
-
-
Northern Ireland
-
Belfast, Northern Ireland, Storbritannien, BT12 7AB
- Indragen
- Belfast City Hospital | Oncology
-
-
Surrey
-
Guildford, Surrey, Storbritannien, GU2 7XX
- Aktiv, inte rekryterande
- Royal Surrey County Hospital | Cancer Centre
-
-
Wales
-
Cardiff, Wales, Storbritannien, CF14 2TL
- Indragen
- Velindre Cancer Centre | Clinical Trials Unit
-
-
-
-
-
Lund, Sverige, 221 85
- Aktiv, inte rekryterande
- Skånes Universitetssjukhus - Lund - Lungmedicin
-
-
Västerbotten County
-
Umeå, Västerbotten County, Sverige, 901 85
- Avslutad
- Norrlands Universitetssjukhus Umeå - Cancercentrum
-
-
-
-
-
Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital | Oncology
-
Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center | Oncology
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Sydkorea, 16247
- Har inte rekryterat ännu
- St Vincent's Hospital | Oncology
-
-
Gyeongsangnam-do
-
Jinju, Gyeongsangnam-do, Sydkorea, 52727
- Har inte rekryterat ännu
- Gyeongsang National University Hospital | Oncology
-
Yangsan, Gyeongsangnam-do, Sydkorea, 50612
- Avslutad
- Pusan National University Yangsan Hospital | Pulmonology
-
-
Jeollanam-do
-
Hwasun-gun, Jeollanam-do, Sydkorea, 58128
- Har inte rekryterat ännu
- Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
-
-
North Chungcheong
-
Chungcheongbuk-do, North Chungcheong, Sydkorea, 28644
- Har inte rekryterat ännu
- Chungbuk National University Hospital | Hematology and Oncology
-
-
Seoul
-
Jongno -Gu, Seoul, Sydkorea, 03080
- Rekrytering
- Seoul National University Hospital | Oncology
-
-
-
-
-
Kaohsiung City, Taiwan, 807377
- Avslutad
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung, Taiwan, 40705
- Rekrytering
- Taichung Veterans General Hospital
-
Taichung, Taiwan, 402306
- Aktiv, inte rekryterande
- Chung Shan Medical University Hospital
-
Tainan, Taiwan, 704
- Aktiv, inte rekryterande
- National Cheng Kung University Hospital
-
Tainan, Taiwan, 73657
- Avslutad
- Chi-Mei Medical Center, Liouyine
-
Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Aktiv, inte rekryterande
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 100225
- Rekrytering
- National Taiwan University Hospital (NTUH) - Cancer Research Center
-
-
-
-
Moravian-Silesian Region
-
Nový Jičín, Moravian-Silesian Region, Tjeckien, 741 01
- Indragen
- Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
-
Ostrava - Vítkovice, Moravian-Silesian Region, Tjeckien, 703 00
- Indragen
- Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
-
-
Olomouc Region
-
Olomouc, Olomouc Region, Tjeckien, 779 00
- Indragen
- Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
-
-
South Moravian
-
Brno, South Moravian, Tjeckien, 602 00
- Rekrytering
- Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
-
-
Zlín
-
Zlín, Zlín, Tjeckien, 762 75
- Indragen
- Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
-
-
-
-
-
Istanbul, Turkiet (Türkiye), 34899
- Avslutad
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Izmir, Turkiet (Türkiye), 35100
- Aktiv, inte rekryterande
- Ege Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Turkiet (Türkiye), 54100
- Har inte rekryterat ännu
- Sakarya Universitesi Egitim ve Arastirma Hastanesi
-
-
Adana
-
Yüreğir, Adana, Turkiet (Türkiye), 1370
- Avslutad
- Adana Sehir Egitim ve Arastirma Hastanesi
-
-
Aksaray
-
Bilkent Ankara, Aksaray, Turkiet (Türkiye), 6800
- Aktiv, inte rekryterande
- Ankara Bilkent Sehir Hastanesi
-
-
Ankara
-
Yenimahalle, Ankara, Turkiet (Türkiye), 6170
- Har inte rekryterat ännu
- Ankara Etlik Sehir Hastanesi
-
-
Istanbul
-
Kadıköy, Istanbul, Turkiet (Türkiye), 34722
- Aktiv, inte rekryterande
- İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
-
Küçükçekmece, Istanbul, Turkiet (Türkiye), 34295
- Har inte rekryterat ännu
- İ.A.Ü. VM Medical Park Florya Hastanesi
-
-
-
-
-
Berlin, Tyskland, 12203
- Har inte rekryterat ännu
- Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
-
-
Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70376
- Avslutad
- Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin
-
-
Bavaria
-
Nuremberg, Bavaria, Tyskland, 90419
- Aktiv, inte rekryterande
- Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde)
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Har inte rekryterat ännu
- Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
-
Giessen, Hesse, Tyskland, 35392
- Har inte rekryterat ännu
- Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie
-
-
North Rhine-Westphalia
-
Cologne, North Rhine-Westphalia, Tyskland, 51109
- Aktiv, inte rekryterande
- Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
-
Essen, North Rhine-Westphalia, Tyskland, 45147
- Aktiv, inte rekryterande
- Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
-
Hemer, North Rhine-Westphalia, Tyskland, 58675
- Aktiv, inte rekryterande
- Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin
-
-
-
-
Dnipropetrovsk Oblast
-
Dnipro, Dnipropetrovsk Oblast, Ukraina, 49102
- Har inte rekryterat ännu
- LLC "RDP Ukraine" - Medical Department
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraina, 25006
- Har inte rekryterat ännu
- Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
-
-
Kyiv City
-
Kyiv, Kyiv City, Ukraina, 03115
- Har inte rekryterat ännu
- Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
-
Kyiv, Kyiv City, Ukraina, 03189
- Aktiv, inte rekryterande
- Limited Liability Company "MedOffice Group Medical Center"
-
Kyiv, Kyiv City, Ukraina, 3039
- Har inte rekryterat ännu
- Medical Center LLC "Verum Expert Clinic"
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, Ukraina, 33010
- Aktiv, inte rekryterande
- Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
-
-
Volyn Oblast
-
Lutsk, Volyn Oblast, Ukraina, 43018
- Har inte rekryterat ännu
- Regional Medical Oncology Centre_Oncology Chemotherapy Department
-
-
Zakarpattia Oblast
-
Uzhhorod, Zakarpattia Oblast, Ukraina, 88000
- Har inte rekryterat ännu
- MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
-
-
-
-
-
Budapest, Ungern, 1145
- Indragen
- Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
-
-
Komárom-Esztergom
-
Tatabánya, Komárom-Esztergom, Ungern, 2800
- Indragen
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
-
-
-
-
-
Vienna, Österrike, 1210
- Aktiv, inte rekryterande
- Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
-
-
State of Salzburg
-
Vienna, State of Salzburg, Österrike, 1090
- Indragen
- Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
-
Vienna, State of Salzburg, Österrike, 1090
- Indragen
- Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
-
-
State of Vienna
-
Vienna, State of Vienna, Österrike, 1090
- Indragen
- Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sevabertinib
Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. |
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. |
Intravenous (IV) infusion IV infusion IV infusion IV infusion |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of response (DOR) som bedömts av utredaren
Tidsram: Upp till cirka 4 år
|
Upp till cirka 4 år
|
|
|
Övergripande överlevnad (OS)
Tidsram: Upp till cirka 4 år.
|
Upp till cirka 4 år.
|
|
|
Objektiv svarsfrekvens (ORR) per RECIST 1.1 som bedöms av utredaren
Tidsram: Upp till cirka 4 år
|
Upp till cirka 4 år
|
|
|
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 augusti 2024
Primärt slutförande (Beräknad)
28 oktober 2027
Avslutad studie (Beräknad)
27 juni 2029
Studieregistreringsdatum
Först inskickad
5 juni 2024
Först inskickad som uppfyllde QC-kriterierna
5 juni 2024
Första postat (Faktisk)
11 juni 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 november 2026
Senast verifierad
15 oktober 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Aminosyror, peptider och proteiner
- Organiska kemikalier
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Oorganiska kemikalier
- Klorföreningar
- Kväveföreningar
- Koordinationskomplex
- Guanin
- Hypoxantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyror, sur
- Aminosyror
- Aminosyror, dikarboxyl
- Platinaföreningar
- Pemetrexed
- Karboplatin
- Cisplatin
- pembrolizumab
Andra studie-ID-nummer
- 22615
- 2024-511319-91-00 (Annan identifierare: CTIS (EU))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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