Utprøving av terapeutisk kreftvaksine OSE2101 hos pasienter med ikke-småcellet lungekreft og sekundær motstand mot immunsjekkpunkthemmer (ARTEMIA)
1. oktober 2026 oppdatert av: OSE Immunotherapeutics
En randomisert, åpen fase 3-studie som sammenligner effektiviteten og sikkerheten til OSE2101 versus Docetaxel hos HLA-A2-positive pasienter med metastatisk ikke-småcellet lungekreft (NSCLC) med sekundær motstand mot immunsjekkpunkthemmere
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
363
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Caroline Chevalier, MSc, MPH
- Telefonnummer: +33 630 842 002
- E-post: caroline.chevalier@ose-immuno.com
Studer Kontakt Backup
- Navn: Bérangère Vasseur, MD
- Telefonnummer: +33 676 448 160
- E-post: berangere.vasseur@ose-immuno.com
Studiesteder
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Antwerpen
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Brasschaat, Antwerpen, Belgia, 2930
- Rekruttering
- Algemeen Ziekenhuis Klina
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Flemish Brabant
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Leuven, Flemish Brabant, Belgia, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Limburg
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Hasselt, Limburg, Belgia, 3500
- Rekruttering
- Jessa Ziekenhuis - Campus Virga Jesse
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Oost-Vlaaderen
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Ghent, Oost-Vlaaderen, Belgia, 9000
- Rekruttering
- Algemeen Ziekenhuis Maria Middelares
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Wallonia
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Namur, Wallonia, Belgia, B-5000
- Rekruttering
- Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgia, 8500
- Rekruttering
- Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
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Roeselare, West-Vlaanderen, Belgia, 8800
- Rekruttering
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Roeselare, West-Vlaanderen, Belgia, 8800
- Aktiv, ikke rekrutterende
- Algemeen Ziekenhuis Delta - Campus Rembert Torhout
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Roeselare, West-Vlaanderen, Belgia
- Aktiv, ikke rekrutterende
- Algemeen Ziekenhuis Delta - Campus Menen
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Rekruttering
- Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
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Montreal, Quebec, Canada, H4A 3J1
- Avsluttet
- McGill University Health Centre
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Rimouski, Quebec, Canada, G5L 5T1
- Rekruttering
- Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
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California
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Beverly Hills, California, Forente stater, 90211
- Rekruttering
- Clinical Research Advisors, LLC
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Encino, California, Forente stater, 90211
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - Encino
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Los Angeles, California, Forente stater, 90048
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - West Hollywood
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Los Angeles, California, Forente stater, 90211
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - Korea Town
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Colorado
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Littleton, Colorado, Forente stater, 80218
- Tilbaketrukket
- SCL Health - Saint Joseph Hospital Cancer Center
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Wheat Ridge, Colorado, Forente stater, 80033-6013
- Rekruttering
- Lutheran Medical Center - Cancer Centers of Colorado
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Connecticut
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Norwich, Connecticut, Forente stater, 06360
- Rekruttering
- Eastern Connecticut Hematology and Oncology Associates
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- Georgetown Lombardi Comprehensive Cancer Center
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Florida
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Bradenton, Florida, Forente stater, 34210
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Bradenton Clinic
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Brandon, Florida, Forente stater, 33511
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Brandon Clinic
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Fleming Island, Florida, Forente stater, 32003
- Rekruttering
- Cancer Specialists of North Florida - Fleming Island
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Jacksonville, Florida, Forente stater, 32258
- Aktiv, ikke rekrutterende
- Cancer Specialists of North Florida - Baptist South
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Jacksonville, Florida, Forente stater, 32256-6932
- Rekruttering
- Cancer Specialists of North Florida - Southpoint
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Jacksonville, Florida, Forente stater, 32204
- Rekruttering
- Cancer Specialists of North Florida - Riverside
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Jacksonville, Florida, Forente stater, 32218
- Rekruttering
- Cancer Specialists of North Florida - Northside
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Jacksonville, Florida, Forente stater, 32207
- Rekruttering
- Cancer Specialists of North Florida Southside
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Jacksonville Beach, Florida, Forente stater, 32250
- Rekruttering
- Cancer Specialists of North Florida
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Largo, Florida, Forente stater, 33770
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Largo Clinic
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Neptune Beach, Florida, Forente stater, 32266
- Aktiv, ikke rekrutterende
- Cancer Specialists of North Florida - Beaches
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Palm Harbor, Florida, Forente stater, 34685
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Palm Harbor Clinic
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Saint Augustine, Florida, Forente stater, 32086
- Rekruttering
- Cancer Specialists Of North Florida - St. Augustine
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St. Petersburg, Florida, Forente stater, 33709
- Rekruttering
- Comprehensive Hematology Oncology
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St. Petersburg, Florida, Forente stater, 33709
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Bayfront Clinic
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Trinity, Florida, Forente stater, 34655
- Rekruttering
- Comprehensive Hematology Oncology - Trinity Clinic
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois Cancer Center
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Kansas
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Merriam, Kansas, Forente stater, 66204
- Tilbaketrukket
- Alliance for Multispecialty Research (AMR) - Kansas City Oncology
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Aktiv, ikke rekrutterende
- Mary Bird Perkins Cancer Center - Baton Rouge
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Covington, Louisiana, Forente stater, 70433
- Rekruttering
- Pontchartrain Cancer Center - Covington Office
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Hammond, Louisiana, Forente stater, 70403-1452
- Rekruttering
- Pontchartrain Cancer Center - Hammond Office
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Maryland
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Baltimore, Maryland, Forente stater, 21229
- Rekruttering
- Ascension Saint Agnes Hospital
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- Rekruttering
- University of Massachusetts Memorial Medical Center
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Nebraska
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Lincoln, Nebraska, Forente stater, 68506
- Rekruttering
- Nebraska Hematology-Oncology - Revive Research Institute LLC
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New York
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Babylon, New York, Forente stater, 11702
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Babylon Medical Oncology
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Brewster, New York, Forente stater, 10509
- Avsluttet
- Optum Medical Care - Carmel/Brewster Campus
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Brooklyn, New York, Forente stater, 11201
- Avsluttet
- Brooklyn Radiation Oncology
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Fishkill, New York, Forente stater, 12524
- Avsluttet
- Optum Medical Care - Fishkill Westage Campus
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Lake Success, New York, Forente stater, 11042
- Avsluttet
- Clinical Research Alliance
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Mount Kisco, New York, Forente stater, 10549
- Avsluttet
- Optum Medical Care - Mount Kisco Campus 90
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New Hyde Park, New York, Forente stater, 11042
- Avsluttet
- Optum Hematology Oncology - Lake Success
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New Hyde Park, New York, Forente stater, 11042
- Rekruttering
- New York Cancer & Blood Specialists - New Hyde Park
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New York, New York, Forente stater, 10028
- Rekruttering
- New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
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New York, New York, Forente stater, 10028
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Central Park Medical Oncology
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Patchogue, New York, Forente stater, 11772
- Rekruttering
- New York Cancer & Blood Specialists - Patchogue Medical Oncology
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Port Jefferson Station, New York, Forente stater, 11776
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
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Port Jefferson Station, New York, Forente stater, 11776
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
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Poughkeepsie, New York, Forente stater, 12601
- Avsluttet
- Optum Medical Care - Poughkeepsie
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The Bronx, New York, Forente stater, 10469
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Eastchester Cancer Care Center
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The Bronx, New York, Forente stater, 10469
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Riverhead Medical Oncology
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Ohio
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Perrysburg, Ohio, Forente stater, 43551
- Aktiv, ikke rekrutterende
- Mercy Health - Perrysburg Cancer Center
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Toledo, Ohio, Forente stater, 43623
- Aktiv, ikke rekrutterende
- Mercy Health - St. Anne Cancer Center
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South Carolina
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Greenville, South Carolina, Forente stater, 29607
- Rekruttering
- Bon Secours Hematology and Oncology
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Tennessee
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Chattanooga, Tennessee, Forente stater, 36404
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Chattanooga - Medical Park II
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Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Tennessee Oncology - Chattanooga - Memorial Plaza
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Chattanooga, Tennessee, Forente stater, 37403
- Rekruttering
- Tennessee Oncology - Chattanooga - Downtown
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Chattanooga, Tennessee, Forente stater, 37403
- Rekruttering
- Tennessee Oncology - Chattanooga - GHCR Site I
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Cleveland, Tennessee, Forente stater, 37311
- Rekruttering
- Tennessee Oncology - Cleveland Clinic
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Cookeville, Tennessee, Forente stater, 38501
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Cookeville Clinic
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Dickson, Tennessee, Forente stater, 37055
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Dickson Clinic
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Franklin, Tennessee, Forente stater, 37067
- Rekruttering
- Tennessee Oncology - Franklin Clinic
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Gallatin, Tennessee, Forente stater, 37066
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Gallatin Clinic
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Hendersonville, Tennessee, Forente stater, 37075
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Hendersonville Clinic
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Hermitage, Tennessee, Forente stater, 37076
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Hermitage - Summit Clinic
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Lebanon, Tennessee, Forente stater, 37090
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Lebanon Clinic
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Murfreesboro, Tennessee, Forente stater, 37129
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Murfreesboro Clinic
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Nashville, Tennessee, Forente stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
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Nashville, Tennessee, Forente stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
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Nashville, Tennessee, Forente stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
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Nashville, Tennessee, Forente stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
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Nashville, Tennessee, Forente stater, 37207
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Skyline Clinic
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Nashville, Tennessee, Forente stater, 37211
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Southern Hills Clinic
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
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Nashville, Tennessee, Forente stater, 37205
- Rekruttering
- Tennessee Oncology - Nashville - St. Thomas West Clinic
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Shelbyville, Tennessee, Forente stater, 37160
- Rekruttering
- Tennessee Oncology - Shelbyville Clinic
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Smyrna, Tennessee, Forente stater, 37167
- Rekruttering
- Tennessee Oncology - Smyrna Clinic
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Washington
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Bonney Lake, Washington, Forente stater, 98391
- Aktiv, ikke rekrutterende
- Northwest Medical Specialties - Bonney Lake
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Federal Way, Washington, Forente stater, 98003
- Aktiv, ikke rekrutterende
- Northwest Medical Specialties - Federal Way
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Gig Harbor, Washington, Forente stater, 98332
- Rekruttering
- Northwest Medical Specialties - Gig Harbor
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Puyallup, Washington, Forente stater, 98373
- Rekruttering
- Northwest Medical Specialties - Puyallup Medical Oncology
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Tacoma, Washington, Forente stater, 98405
- Rekruttering
- Northwest Medical Specialties - Tacoma
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La Roche-sur-Yon, Frankrike, 85000
- Rekruttering
- Centre Hospitalier Départemental Vendée
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Le Mans, Frankrike, 72037
- Rekruttering
- Centre Hospitalier Le Mans
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Nantes, Frankrike, 44093
- Rekruttering
- Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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Alpes-de-Haute-Provence
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Toulon, Alpes-de-Haute-Provence, Frankrike, 83800
- Rekruttering
- Hôpital d'Instruction des Armées Sainte-Anne
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Alsace
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Strasbourg, Alsace, Frankrike, 67091
- Rekruttering
- Nouvel Hôpital Civil
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Auvergne-Rhône-Alpes
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Bron, Auvergne-Rhône-Alpes, Frankrike, 69500
- Aktiv, ikke rekrutterende
- Hôpital Louis Pradel
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Lyon, Auvergne-Rhône-Alpes, Frankrike, 69317
- Rekruttering
- Centre Hospitalier Lyon-Sud
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Lyon, Auvergne-Rhône-Alpes, Frankrike, 69317
- Rekruttering
- Hôpital de la Croix Rousse
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike, 13273
- Rekruttering
- Institut Paoli-Calmettes
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Doubs
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Besançon, Doubs, Frankrike, 25030
- Rekruttering
- Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
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Finistère
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Brest, Finistère, Frankrike, 29200
- Rekruttering
- Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
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Grand Est
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Mulhouse, Grand Est, Frankrike, 68100
- Rekruttering
- Hôpital Emile Muller
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Nancy, Grand Est, Frankrike, 54035
- Rekruttering
- Centre Hospitalier Régional Universitaire de Nancy
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Haute-Vienne
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Limoges, Haute-Vienne, Frankrike, 87000
- Rekruttering
- Centre Hospitalier Universitaire Dupuytren 1
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Hérault
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Montpellier, Hérault, Frankrike, 34295
- Rekruttering
- Hôpital Arnaud de Villeneuve
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35033
- Rekruttering
- Hôpital Pontchaillou
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Loire-Atlantique
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Saint-Herblain, Loire-Atlantique, Frankrike, 44805
- Rekruttering
- Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
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Maine-et-Loire
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Cholet, Maine-et-Loire, Frankrike, 49325
- Rekruttering
- Centre Hospitalier (Ch) De Cholet
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Midi-pyrenees
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Toulouse, Midi-pyrenees, Frankrike, 31059
- Rekruttering
- Hôpital Larrey
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New Aquitaine
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Pessac, New Aquitaine, Frankrike, 33604
- Rekruttering
- Hôpital Haut-Lévêque
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, Frankrike, 13015
- Rekruttering
- Hôpital Nord de Marseille
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Pyrénées-Atlantiques
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Bayonne, Pyrénées-Atlantiques, Frankrike, 64109
- Rekruttering
- Centre Hospitalier de la Côte Basque
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Rhône
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La Tronche, Rhône, Frankrike, 38700
- Rekruttering
- Hôpital Michallon
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Val-de-Marne
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Villejuif, Val-de-Marne, Frankrike, 94805
- Rekruttering
- Gustave Roussy
-
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Vaucluse
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Avignon, Vaucluse, Frankrike, 84000
- Rekruttering
- Institut Sainte Catherine
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Vienne
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Poitiers, Vienne, Frankrike, 86021
- Rekruttering
- Centre Hospitalier Universitaire de Poitiers
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Île-de-France Region
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Bobigny, Île-de-France Region, Frankrike, 93000
- Rekruttering
- Hôpital Avicenne
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Créteil, Île-de-France Region, Frankrike, 94000
- Rekruttering
- Centre Hospitalier Intercommunal de Créteil
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Paris, Île-de-France Region, Frankrike, 75014
- Rekruttering
- Hôpital Cochin
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Paris, Île-de-France Region, Frankrike, 75014
- Rekruttering
- Groupe Hospitalier Paris Saint-Joseph
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Paris, Île-de-France Region, Frankrike, 75020
- Rekruttering
- Hôpital Tenon
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Athens
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Piraeus, Athens, Hellas, 185 47
- Rekruttering
- Metropolitan Hospital
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Attica
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Athens, Attica, Hellas, 11527
- Rekruttering
- General Hospital for Thoracic Diseases Sotiria
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Athens, Attica, Hellas, 11522
- Rekruttering
- Saint Savvas Anticancer - Oncological Hospital of Athens
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Athens, Attica, Hellas, 11526
- Rekruttering
- Henry Dunant Hospital Center
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Nea Kifissia, Attica, Hellas, 14564
- Rekruttering
- Agii Anargiri Cancer Hospital
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Central Macedonia
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Thessaloniki, Central Macedonia, Hellas, 55236
- Rekruttering
- Clinic Agios Loukas
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Crete
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Heraklion, Crete, Hellas, 711 10
- Rekruttering
- University General Hospital of Heraklion (PAGNI)
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Macedoni
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Thessaloniki, Macedoni, Hellas, TK 56403
- Aktiv, ikke rekrutterende
- General Hospital of Thessaloniki Papageorgiou
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Peloponnese
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Patra, Peloponnese, Hellas, 26504
- Rekruttering
- University General Hospital of Patras
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Thessaloniki
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Thessaloniki, Thessaloniki, Hellas, 546 39
- Rekruttering
- Theagenio Anti-Cancer Hospital of Thessaloniki
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Thessaly
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Larissa, Thessaly, Hellas, 411 10
- Rekruttering
- University General Hospital of Larissa
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-
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-
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Genova, Italia, 16132
- Rekruttering
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
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Lecce, Italia, 73100
- Rekruttering
- Ospedale Vito Fazzi Lecce
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Milan, Italia, 20132
- Rekruttering
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS - Istituto Nazionale dei Tumori
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Novara, Italia, 28100
- Rekruttering
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
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Padova, Italia, 35128
- Rekruttering
- Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
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Pisa, Italia, 56126
- Rekruttering
- Azienda Ospedaliero-Universitaria Pisana
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Rimini, Italia, 47923
- Aktiv, ikke rekrutterende
- Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
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Roma, Italia, 00144
- Rekruttering
- IRCCS Istituto Nazionale Tumori Regina Elena
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Rome, Italia, 00152
- Rekruttering
- Azienda Ospedaliera San Camillo Forlanini
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Siena, Italia, 53100
- Rekruttering
- Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italia, 47014
- Rekruttering
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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Lucca
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San Filippo, Lucca, Italia, 55100
- Rekruttering
- Presidio Ospedaliero di Lucca
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Milan
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Rozzano, Milan, Italia, 20089
- Aktiv, ikke rekrutterende
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
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Naples
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Naples, Naples, Italia, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
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Torino
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Orbassano, Torino, Italia, 10043
- Rekruttering
- Azienda Ospedaliero - Universitaria San Luigi Gonzaga
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Verona
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Legnago, Verona, Italia, 37045
- Rekruttering
- Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
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-
-
-
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Groningen, Nederland, 9713 GZ
- Rekruttering
- Universitair Medisch Centrum Groningen
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Gelderland
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Nijmegen, Gelderland, Nederland, 6525 GA
- Rekruttering
- Radboud Universitair Medisch Centrum
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South Holland
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Rotterdam, South Holland, Nederland, 3015 GD
- Rekruttering
- Erasmus Medisch Centrum
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Greater Poland Voivodeship
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Konin, Greater Poland Voivodeship, Polen, 62-500
- Rekruttering
- Przychodnia Lekarska KOMED Roman Karaszewski
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Poznan, Greater Poland Voivodeship, Polen, 60-569
- Rekruttering
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-796
- Rekruttering
- Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-090
- Rekruttering
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
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Lódzkie
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Lodz, Lódzkie, Polen, 93-338
- Rekruttering
- Instytut Centrum Zdrowia Matki Polki
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-210
- Rekruttering
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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-
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Coimbra, Portugal, 3000-075
- Rekruttering
- Unidade Local de Saúde de Coimbra
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Lisbon, Portugal, 1769-001
- Rekruttering
- Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
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Lisbon, Portugal, 1769-001
- Rekruttering
- Hospital CUF Descobertas
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Porto, Portugal, 14341
- Rekruttering
- Hospital CUF Porto
-
Vila Nova de Gaia, Portugal, 4434-502
- Rekruttering
- Unidade Local de Saúde de Gaia/Espinho, E. P. E
-
-
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400015
- Rekruttering
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
-
Dolj
-
Craiova, Dolj, Romania, 200746
- Rekruttering
- Centrul de Oncologie Sf Nectarie
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300239
- Rekruttering
- SC OncoMed SRL
-
-
-
-
-
Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Barcelona, Spania, 08028
- Rekruttering
- Hospital Universitari Dexeus
-
Barcelona, Spania, 08017
- Rekruttering
- Clínica Mi Tres Torres
-
Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebrón
-
Córdoba, Spania, 14004
- Rekruttering
- Hospital Universitario Reina Sofía
-
Girona, Spania, 17007
- Rekruttering
- Hospital Universitari de Girona Dr. Josep Trueta
-
Lugo, Spania, 27004
- Rekruttering
- Hospital Universitario Lucus Augusti
-
Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Madrid, Spania, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañón
-
Madrid, Spania, 28034
- Rekruttering
- Hospital Universitario Ramón y Cajal
-
Málaga, Spania, 29011
- Rekruttering
- Hospital Regional Universitario de Málaga - Hospital General
-
Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spania, 07198
- Rekruttering
- Hospital Son Llàtzer
-
-
Barcelona
-
Badalona, Barcelona, Spania, 08916
- Rekruttering
- Hospital Germans Trias i Pujol
-
L'Hospitalet de Llobregat, Barcelona, Spania, 08907
- Rekruttering
- Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
-
-
Biscay
-
Barakaldo, Biscay, Spania, 48903
- Rekruttering
- Biocruces Bizkaia Instituto de Investigación Sanitaria
-
-
La Coruña
-
A Coruña, La Coruña, Spania, 15006
- Rekruttering
- Complejo Hospitalario Universitario A Coruña
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spania, 35016
- Rekruttering
- Complejo Hospitalario Universitario Insular Materno Infantil
-
-
Madrid
-
Majadahonda, Madrid, Spania, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro - Majadahonda
-
-
Malaga
-
Marbella, Malaga, Spania, 29660
- Rekruttering
- HC Marbella
-
-
-
-
England
-
Leicester, England, Storbritannia, LE2 9LX
- Rekruttering
- University Hospitals of Leicester NHS Trust
-
Manchester, England, Storbritannia, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
-
Metropolitan Borough of Wirral, England, Storbritannia, CH63 4JY
- Rekruttering
- The Clatterbridge Cancer Centre NHS Foundation Trust
-
Sutton, England, Storbritannia, SM2 5PT
- Rekruttering
- The Royal Marsden NHS Foundation Trust
-
-
Scotland
-
Aberdeen, Scotland, Storbritannia, AB25 2ZN
- Rekruttering
- NHS Grampian
-
-
-
-
-
Berlin, Tyskland, 13353
- Rekruttering
- Charité - Universitätsmedizin Berlin
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Tyskland, 69126
- Rekruttering
- Thoraxklinik-Heidelberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70376
- Rekruttering
- Robert-Bosch-Krankenhaus
-
-
Bavaria
-
Gauting, Bavaria, Tyskland, 82131
- Rekruttering
- Asklepios Fachkliniken München-Gauting
-
München, Bavaria, Tyskland, 81925
- Rekruttering
- München Klinik Bogenhausen
-
-
Hesse
-
Kassel, Hesse, Tyskland, 34125
- Aktiv, ikke rekrutterende
- Klinikum Kassel
-
-
North Rhine-Westphalia
-
Aachen, North Rhine-Westphalia, Tyskland, 52074
- Avsluttet
- Universitätsklinikum Aachen
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Rekruttering
- Universitätsklinikum Bonn
-
Essen, North Rhine-Westphalia, Tyskland, 45147
- Rekruttering
- Universitätsklinikum Essen
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Rekruttering
- Universitätsklinikum Gießen und Marburg - Gießen
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland, 06120
- Rekruttering
- Krankenhaus Martha-Maria Halle-Dölau
-
-
Schleswig-Holstein
-
Großhansdorf, Schleswig-Holstein, Tyskland, 22927
- Rekruttering
- LungenClinic Grosshansdorf
-
-
-
-
-
Budapest, Ungarn, 1121
- Rekruttering
- Országos Korányi Pulmonológiai Intézet
-
Gyöngyös, Ungarn, 3200
- Rekruttering
- Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
-
-
Heves County
-
Gyöngyös, Heves County, Ungarn, 3200
- Avsluttet
- Mátrai Gyógyintézet
-
-
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
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:
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
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)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. |
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant. Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. |
|
Aktiv komparator: Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks. |
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. |
|
Annen: GenDx CDx Tedopi
System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi. |
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OS defined as time from randomization to death
Tidsramme: From randomization date through study completion, an average of 3 years
|
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date |
From randomization date through study completion, an average of 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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)
3. desember 2024
Primær fullføring (Antatt)
15. desember 2027
Studiet fullført (Antatt)
15. desember 2028
Datoer for studieregistrering
Først innsendt
7. juni 2024
Først innsendt som oppfylte QC-kriteriene
21. juni 2024
Først lagt ut (Faktiske)
25. juni 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Organiske kjemikalier
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Taxoider
- Cyclodecanes
- Diterpenes
- Docetaxel
Andre studie-ID-numre
- OSE2101C302
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .