En studie for å lære mer om hvor godt BAY 2927088 fungerer og hvor trygt det er sammenlignet med standardbehandling, hos deltakere som har avansert ikke-småcellet lungekreft (NSCLC) med mutasjoner i genene til Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)
3. november 2026 oppdatert av: Bayer
En fase 3 åpen, randomisert, aktivt kontrollert, multisenterforsøk for å evaluere effektiviteten og sikkerheten til oral administrert BAY 2927088 sammenlignet med standardbehandling som førstelinjebehandling hos pasienter med lokalt avansert eller metastatisk ikke-småcellet lungekreft (NSCLC) Med HER2-aktiverende mutasjoner
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.
Studieoversikt
Status
Status
Rekruttering
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Intervensjonell
Registrering (Antatt)
Registrering
444
Fase
Fase
- Fase 3
Utvidet tilgang
Utvidet tilgang
Tilgjengelig
utenfor den kliniske utprøvingen.
Se utvidet tilgangspost.
Tilgjengelig
- Tilgjengelig: Utvidet tilgang er for øyeblikket tilgjengelig for denne undersøkelsesbehandlingen, og pasienter som ikke er deltakere i den kliniske studien kan kanskje få tilgang til stoffet, biologisk eller medisinsk utstyr undersøkes.
- Ikke lenger tilgjengelig: Utvidet tilgang var tilgjengelig for denne intervensjonen tidligere, men er ikke tilgjengelig for øyeblikket og vil ikke være tilgjengelig i fremtiden.
- Midlertidig ikke tilgjengelig: Utvidet tilgang er for øyeblikket ikke tilgjengelig for denne intervensjonen, men forventes å være tilgjengelig i fremtiden.
- Godkjent for markedsføring: Intervensjonen har blitt godkjent av U.S. Food and Drug Administration for bruk av publikum.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
Studiekontakt
- Navn: Bayer Clinical Trials Contact
- Telefonnummer: 18888422937
- E-post: clinical-trials-contact@bayer.com
Studiesteder
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Buenos Aires, Argentina, C1199ABB
- Tilbaketrukket
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1431FWO
- Tilbaketrukket
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
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Buenos Aires, Argentina, C1125 ABD
- Tilbaketrukket
- Fundación Cenit para la Investigación en Neurociencias
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Córdoba, Argentina, X5008HHW
- Tilbaketrukket
- Centro Médico Privado CEMAIC
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Buenos Aires
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TBC, Buenos Aires, Argentina, B1841
- Tilbaketrukket
- Instituto Argentino de Diagnostico y Tratamiento (IADT)
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Río Negro Province
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Viedma, Río Negro Province, Argentina, R8500ACE
- Tilbaketrukket
- Centro de Investigaciones Clínicas, Clínica Viedma
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Aktiv, ikke rekrutterende
- NSW Health - Blacktown Hospital
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Concord, New South Wales, Australia, 2139
- Fullført
- Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit
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Waratah, New South Wales, Australia, 2298
- Aktiv, ikke rekrutterende
- Calvary Mater Hospital Newcastle - Oncology
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Queensland
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Buderim, Queensland, Australia, 4556
- Tilbaketrukket
- University of the Sunshine Coast
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Toowoomba, Queensland, Australia, 4350
- Tilbaketrukket
- Toowoomba Hospital Oncology Clinical Trials
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Aktiv, ikke rekrutterende
- Austin Hospital - Olivia Newton John Cancer Research Institute
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Antwerp
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Antwerp, Antwerp, Belgia, 2650
- Tilbaketrukket
- Antwerp University Hospital | Oncology Department
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Flemish Brabant
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Leuven, Flemish Brabant, Belgia, 3000
- Aktiv, ikke rekrutterende
- UZ Leuven Gasthuisberg - Pneumology Department
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West Flanders
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Roeselare, West Flanders, Belgia, 8800
- Aktiv, ikke rekrutterende
- AZ Delta | Clinical Trial Center - Pneumology
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-
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São Paulo, Brasil, 01323-030
- Rekruttering
- A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante
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São Paulo, Brasil, 90020-090
- Rekruttering
- Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
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São Paulo, Brasil, 01308-050
- Rekruttering
- Hospital Sirio Libanes
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São Paulo, Brasil, 71635-610
- Tilbaketrukket
- Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
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Ceará
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Fortaleza, Ceará, Brasil, 60810-180
- Rekruttering
- Pronutrir Fortaleza - CE
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Federal District
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Brasília, Federal District, Brasil, 04538-132
- Rekruttering
- Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima
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Pernambuco
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Recife, Pernambuco, Brasil, 50070-480
- Rekruttering
- Rede DoR Recife - PE
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59040-000
- Rekruttering
- Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
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Santa Catarina
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Blumenau, Santa Catarina, Brasil, 89010-340
- Rekruttering
- Centro de Pesquisa da Clínica de Oncologia Reichow
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São Paulo
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Bauru, São Paulo, Brasil, 17033-490
- Rekruttering
- NAIC - Instituto do Cancer
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Jaú, São Paulo, Brasil, 14784-400
- Rekruttering
- Fundacao Pio XII - Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Tilbaketrukket
- Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
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Pazardzhik Province
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Panagyurishte, Pazardzhik Province, Bulgaria, 4500
- Har ikke rekruttert ennå
- MHAT Uni Hospital
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Pleven Province
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Pleven, Pleven Province, Bulgaria, 5804
- Har ikke rekruttert ennå
- MHAT "Heart and brain" Pleven
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Plovdiv Province
-
Plovdiv, Plovdiv Province, Bulgaria, 4109
- Tilbaketrukket
- MHAT Park Hospital EOOD
-
Plovdiv, Plovdiv Province, Bulgaria, 4004
- Har ikke rekruttert ennå
- Complex Oncology Center - Plovdiv EOOD
-
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Sofia City Province
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Sofia, Sofia City Province, Bulgaria, 1404
- Rekruttering
- Multiprofile Hospital for Active Treatment "Sveta Sofia"
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Sofia, Sofia City Province, Bulgaria, 1797
- Tilbaketrukket
- Specialized Hospital for Active Treatment of Oncology
-
Sofia, Sofia City Province, Bulgaria, 1797
- Har ikke rekruttert ennå
- University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia
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Sofia, Sofia City Province, Bulgaria, 1303
- Aktiv, ikke rekrutterende
- MHAT Serdikamed
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Varna Province
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Varna, Varna Province, Bulgaria, 9010
- Har ikke rekruttert ennå
- MHAT Sveta Marina EAD
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- Fullført
- BC Cancer | Vancouver
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- Rekruttering
- Brampton Civic Hospital | Oncology
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Toronto, Ontario, Canada, M5G 2C4
- Rekruttering
- Princess Margaret Cancer Centre | Medical Oncology and Hematology
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Rekruttering
- Jewish General Hospital | Pulmonary Oncology
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-
-
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Capital Region / Region Hovedstaden
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Copenhagen, Capital Region / Region Hovedstaden, Danmark, 2100
- Aktiv, ikke rekrutterende
- 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
- Fullført
- Aarhus Universitetshospital
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Herning, Central Denmark Region / Region Midtjylland, Danmark, 7400
- Tilbaketrukket
- 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
- Tilbaketrukket
- 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, ikke rekrutterende
- Odense University Hospital | Svendborg Sygehus - Oncology Department
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-
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
- Tilbaketrukket
- Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka
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Uusimaa
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Helsinki, Uusimaa, Finland, 00180
- Tilbaketrukket
- Docrates Mehiläinen Syöpäsairaala
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California
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Newport Beach, California, Forente stater, 92663
- Tilbaketrukket
- Patty & George Hoag Cancer Center
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San Diego, California, Forente stater, 92037
- Tilbaketrukket
- UC San Diego Health - Moores Cancer Center
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San Francisco, California, Forente stater, 94158
- Rekruttering
- UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
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Santa Monica, California, Forente stater, 90404
- Rekruttering
- UCLA Health Santa Monica Cancer Care
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Florida
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Fort Lauderdale, Florida, Forente stater, 33316
- Rekruttering
- The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
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Miramar, Florida, Forente stater, 33029
- Tilbaketrukket
- Memorial Cancer Institute at Miramar
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Orlando, Florida, Forente stater, 32804
- Har ikke rekruttert ennå
- AdventHealth Cancer Institute Orlando
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Tampa, Florida, Forente stater, 33612
- Tilbaketrukket
- Moffitt Cancer Center - Magnolia Campus
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Georgia
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Atlanta, Georgia, Forente stater, 30318
- Rekruttering
- Piedmont Healthcare - Atlanta
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Columbus, Georgia, Forente stater, 31904
- Rekruttering
- John B. Amos Cancer Center
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois Hospital - Outpatient Cancer Care Center
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Chicago, Illinois, Forente stater, 60637
- Tilbaketrukket
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Har ikke rekruttert ennå
- UM Greenebaum Comprehensive Cancer Center
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- Tilbaketrukket
- UMass Memorial Medical Center - University Campus - Hematology/Oncology
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Michigan
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Farmington Hills, Michigan, Forente stater, 48334
- Tilbaketrukket
- Profound Research -OMG - TriAtria Cancer Center
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Royal Oak, Michigan, Forente stater, 48073
- Tilbaketrukket
- Profound Research - OMG - Royal Oak Cancer Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Tilbaketrukket
- 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, Forente stater, 11042
- Tilbaketrukket
- R.J. Zuckerberg Cancer Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Rekruttering
- UC Medical Center - Oncology
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Maumee, Ohio, Forente stater, 43537
- Rekruttering
- Taylor Cancer Research Center
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Oregon
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Portland, Oregon, Forente stater, 97213
- Tilbaketrukket
- Providence Cancer Institute - Franz Clinic
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Portland, Oregon, Forente stater, 97225
- Tilbaketrukket
- Providence Oncology and Hematology Care Clinic Westside
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Rekruttering
- Allegheny General Hospital
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Texas
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Dallas, Texas, Forente stater, 75235
- Tilbaketrukket
- University Hospital Simmons Cancer Center Lung/Head Neck Clinic
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Houston, Texas, Forente stater, 77030
- Rekruttering
- The University of Texas MD Anderson Cancer Center - Texas Medical Center
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Auvergne-Rhône-Alpes
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La Tronche, Auvergne-Rhône-Alpes, Frankrike, 38700
- Fullført
- Centre Hospitalier Michallon Grenoble - Service pneumologie
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Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrike, 69310
- Aktiv, ikke rekrutterende
- 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, ikke rekrutterende
- 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
- Tilbaketrukket
- hopital Emile Muller - Service Pneumologie
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Hauts-de-France
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Lille, Hauts-de-France, Frankrike, 59000
- Aktiv, ikke rekrutterende
- 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, ikke rekrutterende
- Institut Bergonie - Unicancer Nouvelle Aquitaine
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Limoges, New Aquitaine, Frankrike, 87000
- Aktiv, ikke rekrutterende
- Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique
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Normandy
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Rouen, Normandy, Frankrike, 76031
- Tilbaketrukket
- CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie
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Occitanie
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Montpellier, Occitanie, Frankrike, 34091
- Aktiv, ikke rekrutterende
- 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, ikke rekrutterende
- Hopital Nord Laennec - Oncologie medicale thoracique et digestive
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Saint-Herblain, Pays de la Loire Region, Frankrike, 44800
- Aktiv, ikke rekrutterende
- 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, ikke rekrutterende
- 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, ikke rekrutterende
- Centre Hospitalier Intercommunal Creteil - Service de pneumologie
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Paris, Île-de-France Region, Frankrike, 75014
- Tilbaketrukket
- APHP - Hopital Cochin - Service de Pneumologie
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Paris, Île-de-France Region, Frankrike, 75248
- Aktiv, ikke rekrutterende
- Institut Curie - Paris - Oncologie medicale
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Suresnes, Île-de-France Region, Frankrike, 92150
- Tilbaketrukket
- Hopital Foch - Oncologie digestive et thoracique
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Villejuif, Île-de-France Region, Frankrike, 94800
- Aktiv, ikke rekrutterende
- Gustave Roussy - Departement Oncologie-Radiotherapie
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-
-
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Athens, Hellas, 11526
- Aktiv, ikke rekrutterende
- Ηenry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit
-
Athens, Hellas, 11527
- Aktiv, ikke rekrutterende
- Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine
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Athens, Hellas, 11528
- Aktiv, ikke rekrutterende
- General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA
-
Athens, Hellas, 12462
- Aktiv, ikke rekrutterende
- University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine
-
Larissa, Hellas, 41110
- Tilbaketrukket
- University General Hospital Of Larissa | Medical Oncology
-
Piraeus, Hellas, 18547
- Tilbaketrukket
- Metropolitan Hospital- 4th Oncology Clinic
-
Pylaia Thessaloniki, Hellas, 555 35
- Tilbaketrukket
- Genesis Hospital- Department of Pathological Oncology
-
Thessaloniki, Hellas, 57010
- Aktiv, ikke rekrutterende
- Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department
-
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Attica
-
Chaïdári, Attica, Hellas, 12462
- Tilbaketrukket
- University General Hospital Attikon-4th Department of Internal Medicine
-
-
-
-
-
Kowloon, Hong Kong, 00000
- Aktiv, ikke rekrutterende
- Hong Kong United Oncology Centre
-
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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
- Har ikke rekruttert ennå
- Queen Mary Hospital
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-
-
-
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Jerusalem, Israel, 91031
- Aktiv, ikke rekrutterende
- Shaare Zedek Medical Center - Oncology Institute
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Tel Aviv, Israel, 6423906
- Fullført
- Tel Aviv Sourasky Medical Center - Oncology Department
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Central District
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Ashdod, Central District, Israel, 7747629
- Aktiv, ikke rekrutterende
- Assuta Ashdod Public Hospital (R.A)
-
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Southern District
-
Beersheba, Southern District, Israel, 8410101
- Fullført
- Clalit Health | Soroka Medical Center - Oncology department
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-
-
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Apulia
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Lecce, Apulia, Italia, 73100
- Tilbaketrukket
- Ospedale Vito Fazzi Lecce - Oncologia
-
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Campania
-
Avellino, Campania, Italia, 83100
- Fullført
- AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica
-
-
Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40138
- Aktiv, ikke rekrutterende
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica
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Meldola, Emilia-Romagna, Italia, 47014
- Aktiv, ikke rekrutterende
- 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, Italia, 33081
- Aktiv, ikke rekrutterende
- Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
-
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Lazio
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Rome, Lazio, Italia, 00144
- Aktiv, ikke rekrutterende
- I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2
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Rome, Lazio, Italia, 00168
- Aktiv, ikke rekrutterende
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare
-
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Lombardy
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Milan, Lombardy, Italia, 20132
- Fullført
- Ospedale San Raffaele s.r.l. - Oncologia Medica
-
Milan, Lombardy, Italia, 20133
- Aktiv, ikke rekrutterende
- Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
-
Milan, Lombardy, Italia, 20141
- Aktiv, ikke rekrutterende
- Istituto Europeo di Oncologia s.r.l - Oncologia Toracica
-
Rozzano, Lombardy, Italia, 20089
- Aktiv, ikke rekrutterende
- Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
-
Varese, Lombardy, Italia, 21100
- Tilbaketrukket
- ASST Sette Laghi_Ospedale Macchi - Oncologia
-
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Piedmont
-
Orbassano, Piedmont, Italia, 10043
- Aktiv, ikke rekrutterende
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
-
-
Sicily
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Palermo, Sicily, Italia, 90146
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica
-
-
Tuscany
-
Florence, Tuscany, Italia, 50134
- Aktiv, ikke rekrutterende
- Careggi University Hospital - Oncologia Clinica
-
-
Veneto
-
Padova, Veneto, Italia, 35128
- Aktiv, ikke rekrutterende
- Istituto Oncologico Veneto_Padova - UOC Oncologia 2
-
Verona, Veneto, Italia, 37134
- Tilbaketrukket
- Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
-
-
-
-
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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
- Har ikke rekruttert ennå
- 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
- Har ikke rekruttert ennå
- Kindai University Hospital
-
-
Saitama
-
Kitaadachi, Saitama, Japan, 362-0806
- Aktiv, ikke rekrutterende
- Saitama Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8603
- Har ikke rekruttert ennå
- 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)
-
-
-
-
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
- Har ikke rekruttert ennå
- The People's Liberation Army General Hospital (Beijing 301 Hospital)
-
Beijing, Beijing Municipality, Kina, 100021
- Har ikke rekruttert ennå
- 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
- Fullført
- 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
- Tilbaketrukket
- 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
-
-
-
-
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
- Tilbaketrukket
- University Hospital Kebangsaan Malaysia
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Malaysia, 10050
- Har ikke rekruttert ennå
- Gleneagles Penang Medical Center
-
Perai, Pulau Pinang, Malaysia, 13700
- Aktiv, ikke rekrutterende
- Sunway Medical Centre Penang
-
-
Selangor
-
Petaling Jaya, Selangor, Malaysia, 46050
- Har ikke rekruttert ennå
- Beacon Hospital
-
Shah Alam, Selangor, Malaysia, 40460
- Har ikke rekruttert ennå
- Columbia Asia Hospital Bukit Rimau
-
Subang Jaya, Selangor, Malaysia, 47500
- Aktiv, ikke rekrutterende
- Sunway Medical Centre
-
-
-
-
-
Puebla City, Mexico, 72530
- Har ikke rekruttert ennå
- Clinica Integral Internacional de Oncologia S. de R.L. de C.V.
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 14080
- Fullført
- 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
-
-
-
-
Gelderland
-
Nijmegen, Gelderland, Nederland, 6500 HB
- Tilbaketrukket
- Radboud University Medical Center | Afdeling Interne Geneeskunde
-
-
North Holland
-
Amsterdam, North Holland, Nederland, 1066 CX
- Aktiv, ikke rekrutterende
- Nederlands Kanker Instituut
-
-
-
-
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
- Tilbaketrukket
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
Masovian Voivodeship
-
Otwock, Masovian Voivodeship, Polen, 05-400
- Tilbaketrukket
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Tilbaketrukket
- Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej
-
Warsaw, Masovian Voivodeship, Polen, 01-138
- Tilbaketrukket
- Instytut Gruzlicy i Chorob Pluc
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-276
- Tilbaketrukket
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 92-213
- Fullført
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
-
-
Świętokrzyskie Voivodeship
-
Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
- Tilbaketrukket
- Swietokrzyskie Centrum Onkologii
-
-
-
-
-
Lisbon, Portugal, 1769-001
- Rekruttering
- CHULN - Hospital Pulido Valente
-
Lisbon, Portugal, 1400-038
- Fullført
- Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
-
Porto, Portugal, 4200-072
- Rekruttering
- IPO Porto
-
-
Beira Litoral
-
Coimbra, Beira Litoral, Portugal, 3004-561
- Fullført
- 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
-
-
-
-
Bucharest Municipality
-
Bucharest, Bucharest Municipality, Romania, 22328
- Aktiv, ikke rekrutterende
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II
-
Bucharest, Bucharest Municipality, Romania, 30171
- Tilbaketrukket
- Spitalul Clinic Coltea
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400015
- Tilbaketrukket
- CardioMed S.R.L.
-
Cluj-Napoca, Cluj, Romania, 400015
- Aktiv, ikke rekrutterende
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
-
Comuna Floresti
-
Florești, Comuna Floresti, Romania, 407280
- Aktiv, ikke rekrutterende
- Radiotherapy Center Cluj SRL
-
-
Constanța County
-
Ovidiu, Constanța County, Romania, 905900
- Tilbaketrukket
- S.C Ovidius Clinical Hospital SRL - Oncology Department
-
-
Dolj
-
Craiova, Dolj, Romania, 200385
- Tilbaketrukket
- Sc Oncolab Srl
-
Craiova, Dolj, Romania, 200745
- Aktiv, ikke rekrutterende
- Centrul de Oncologie Sfantul Nectarie
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300166
- Tilbaketrukket
- Oncocenter
-
-
-
-
-
Singapore, Singapore, 308433
- Fullført
- Tan Tock Seng Hospital
-
Singapore, Singapore, 168583
- Aktiv, ikke rekrutterende
- National Cancer Center Singapore - Oncology Department
-
Singapore, Singapore, 188770
- Fullført
- Raffles Cancer Centre
-
Singapore, Singapore, 258499
- Aktiv, ikke rekrutterende
- OncoCare Cancer Centre | Gleneagles Medical Centre
-
Singapore, Singapore, 329563
- Fullført
- Curie Oncology | Farrer
-
-
-
-
-
Trnava, Slovakia, 917 75
- Fullført
- Fakultna nemocnica Trnava
-
-
Presov
-
Poprad, Presov, Slovakia, 058 01
- Tilbaketrukket
- POKO Poprad s.r.o.
-
-
-
-
-
A Coruña, Spania, 15006
- Tilbaketrukket
- Complexo Hospitalario Universitario A Coruna | Oncologia
-
Barcelona, Spania, 08028
- Aktiv, ikke rekrutterende
- Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
-
Barcelona, Spania, 08035
- Aktiv, ikke rekrutterende
- Hospital Universitari Vall D Hebron | Oncologia
-
Barcelona, Spania, 08036
- Tilbaketrukket
- Hospital Clinic De Barcelona | Oncologia
-
Madrid, Spania, 28034
- Tilbaketrukket
- Hospital Universitario Ramon Y Cajal | Oncologia
-
Madrid, Spania, 28040
- Tilbaketrukket
- Hospital Universitario Fundacion Jimenez Diaz | Oncologia
-
Madrid, Spania, 28009
- Tilbaketrukket
- Hospital General Universitario Gregorio Maranon | Oncologia
-
Valencia, Spania, 46026
- Aktiv, ikke rekrutterende
- Hospital Universitario Y Politecnico La Fe | Oncologia
-
Valencia, Spania, 46009
- Tilbaketrukket
- Fundacion Instituto Valenciano De Oncologia | Oncologia
-
-
Barcelona
-
Badalona, Barcelona, Spania, 08916
- Aktiv, ikke rekrutterende
- Hospital Germans Trias I Pujol | Oncologia
-
-
Madrid
-
Majadahonda, Madrid, Spania, 28222
- Aktiv, ikke rekrutterende
- Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia
-
-
Navarre
-
Pamplona, Navarre, Spania, 31008
- Aktiv, ikke rekrutterende
- Hospital Universitario De Navarra | Oncologia
-
-
-
-
Devon
-
Torquay, Devon, Storbritannia, TQ2 7AA
- Aktiv, ikke rekrutterende
- Torbay Hospital | Oncology
-
-
Northern Ireland
-
Belfast, Northern Ireland, Storbritannia, BT12 7AB
- Tilbaketrukket
- Belfast City Hospital | Oncology
-
-
Surrey
-
Guildford, Surrey, Storbritannia, GU2 7XX
- Aktiv, ikke rekrutterende
- Royal Surrey County Hospital | Cancer Centre
-
-
Wales
-
Cardiff, Wales, Storbritannia, CF14 2TL
- Tilbaketrukket
- Velindre Cancer Centre | Clinical Trials Unit
-
-
-
-
-
Fribourg, Sveits, 1708
- Tilbaketrukket
- HFR Freiburg - Kantonsspital
-
-
Canton of Aargau
-
Baden, Canton of Aargau, Sveits, 5404
- Aktiv, ikke rekrutterende
- Kantonsspital Baden
-
-
-
-
-
Lund, Sverige, 221 85
- Aktiv, ikke rekrutterende
- Skånes Universitetssjukhus - Lund - Lungmedicin
-
-
Västerbotten County
-
Umeå, Västerbotten County, Sverige, 901 85
- Fullført
- Norrlands Universitetssjukhus Umeå - Cancercentrum
-
-
-
-
-
Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital | Oncology
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center | Oncology
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Sør -Korea, 16247
- Har ikke rekruttert ennå
- St Vincent's Hospital | Oncology
-
-
Gyeongsangnam-do
-
Jinju, Gyeongsangnam-do, Sør -Korea, 52727
- Har ikke rekruttert ennå
- Gyeongsang National University Hospital | Oncology
-
Yangsan, Gyeongsangnam-do, Sør -Korea, 50612
- Avsluttet
- Pusan National University Yangsan Hospital | Pulmonology
-
-
Jeollanam-do
-
Hwasun-gun, Jeollanam-do, Sør -Korea, 58128
- Har ikke rekruttert ennå
- Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine
-
-
North Chungcheong
-
Chungcheongbuk-do, North Chungcheong, Sør -Korea, 28644
- Har ikke rekruttert ennå
- Chungbuk National University Hospital | Hematology and Oncology
-
-
Seoul
-
Jongno -Gu, Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital | Oncology
-
-
-
-
-
Kaohsiung City, Taiwan, 807377
- Fullført
- 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
- Fullført
- 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
-
-
-
-
Moravian-Silesian Region
-
Nový Jičín, Moravian-Silesian Region, Tsjekkia, 741 01
- Tilbaketrukket
- Nemocnice AGEL Nový Jičín a.s. - Oddělení radioterapie a onkologie
-
Ostrava - Vítkovice, Moravian-Silesian Region, Tsjekkia, 703 00
- Tilbaketrukket
- Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddělení
-
-
Olomouc Region
-
Olomouc, Olomouc Region, Tsjekkia, 779 00
- Tilbaketrukket
- Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy
-
-
South Moravian
-
Brno, South Moravian, Tsjekkia, 602 00
- Rekruttering
- Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
-
-
Zlín
-
Zlín, Zlín, Tsjekkia, 762 75
- Tilbaketrukket
- Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie
-
-
-
-
-
Istanbul, Tyrkia (Türkiye), 34899
- Fullført
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Izmir, Tyrkia (Türkiye), 35100
- Aktiv, ikke rekrutterende
- Ege Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Tyrkia (Türkiye), 54100
- Har ikke rekruttert ennå
- Sakarya Universitesi Egitim ve Arastirma Hastanesi
-
-
Adana
-
Yüreğir, Adana, Tyrkia (Türkiye), 1370
- Fullført
- Adana Sehir Egitim ve Arastirma Hastanesi
-
-
Aksaray
-
Bilkent Ankara, Aksaray, Tyrkia (Türkiye), 6800
- Aktiv, ikke rekrutterende
- Ankara Bilkent Sehir Hastanesi
-
-
Ankara
-
Yenimahalle, Ankara, Tyrkia (Türkiye), 6170
- Har ikke rekruttert ennå
- Ankara Etlik Sehir Hastanesi
-
-
Istanbul
-
Kadıköy, Istanbul, Tyrkia (Türkiye), 34722
- Aktiv, ikke rekrutterende
- İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
-
Küçükçekmece, Istanbul, Tyrkia (Türkiye), 34295
- Har ikke rekruttert ennå
- İ.A.Ü. VM Medical Park Florya Hastanesi
-
-
-
-
-
Berlin, Tyskland, 12203
- Har ikke rekruttert ennå
- Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
-
-
Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70376
- Fullført
- 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
- Har ikke rekruttert ennå
- Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie
-
Giessen, Hesse, Tyskland, 35392
- Har ikke rekruttert ennå
- 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
-
-
-
-
Dnipropetrovsk Oblast
-
Dnipro, Dnipropetrovsk Oblast, Ukraina, 49102
- Har ikke rekruttert ennå
- LLC "RDP Ukraine" - Medical Department
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraina, 25006
- Har ikke rekruttert ennå
- Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
-
-
Kyiv City
-
Kyiv, Kyiv City, Ukraina, 03115
- Har ikke rekruttert ennå
- Kyiv City Clinical Oncology Center - Department of Chemotherapy #1
-
Kyiv, Kyiv City, Ukraina, 03189
- Aktiv, ikke rekrutterende
- Limited Liability Company "MedOffice Group Medical Center"
-
Kyiv, Kyiv City, Ukraina, 3039
- Har ikke rekruttert ennå
- Medical Center LLC "Verum Expert Clinic"
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, Ukraina, 33010
- Aktiv, ikke rekrutterende
- Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department
-
-
Volyn Oblast
-
Lutsk, Volyn Oblast, Ukraina, 43018
- Har ikke rekruttert ennå
- Regional Medical Oncology Centre_Oncology Chemotherapy Department
-
-
Zakarpattia Oblast
-
Uzhhorod, Zakarpattia Oblast, Ukraina, 88000
- Har ikke rekruttert ennå
- MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department
-
-
-
-
-
Budapest, Ungarn, 1145
- Tilbaketrukket
- Budapesti Uzsoki Utcai Korhaz - Tüdőgyógyászati Osztály
-
-
Komárom-Esztergom
-
Tatabánya, Komárom-Esztergom, Ungarn, 2800
- Tilbaketrukket
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
-
-
-
-
-
Vienna, Østerrike, 1210
- Aktiv, ikke rekrutterende
- Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik
-
-
State of Salzburg
-
Vienna, State of Salzburg, Østerrike, 1090
- Tilbaketrukket
- Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III
-
Vienna, State of Salzburg, Østerrike, 1090
- Tilbaketrukket
- Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde
-
-
State of Vienna
-
Vienna, State of Vienna, Østerrike, 1090
- Tilbaketrukket
- Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
2
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Varighet av respons (DOR) som vurdert av etterforskeren
Tidsramme: Opptil ca 4 år
|
Opptil ca 4 år
|
|
|
Total Survival (OS)
Tidsramme: Opptil omtrent 4 år.
|
Opptil omtrent 4 år.
|
|
|
Objektiv svarprosent (ORR) per RECIST 1.1 som vurdert av etterforskeren
Tidsramme: Opptil omtrent 4 år
|
Opptil omtrent 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
28. august 2024
Primær fullføring (Antatt)
Primær fullføring
28. oktober 2027
Studiet fullført (Antatt)
Studiet fullført
27. juni 2029
Datoer for studieregistrering
Først innsendt
Først innsendt
5. juni 2024
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
5. juni 2024
Først lagt ut (Faktiske)
Først lagt ut
11. juni 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
4. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. november 2026
Sist bekreftet
Sist bekreftet
15. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Platinumforbindelser
- Pemetrexed
- Karboplatin
- Cisplatin
- pembrolizumab
Andre studie-ID-numre
Andre studie-ID-numre
- 22615
- 2024-511319-91-00 (Annen identifikator: CTIS (EU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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