Studie som sammenligner Tarlatamab og Durvalumab versus Durvalumab alene i førstelinjes omfattende småcellet lungekreft (ES-SCLC) etter platina, etoposid og durvalumab (DeLLphi-305)
5. november 2026 oppdatert av: Amgen
En fase 3, åpen, multisenter, randomisert studie av Tarlatamab i kombinasjon med Durvalumab vs Durvalumab alene hos pasienter med omfattende småcellet lungekreft etter platina, etoposid og durvalumab
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
563
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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La Rioja, Argentina, F5300COE
- Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1426ANZ
- Instituto Alexander Fleming
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Río Negro Province
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Cipolletti, Río Negro Province, Argentina, 8324
- Fundacion Medica de Rio Negro y Neuquen
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Exelsus Oncologia Clinica
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris OBrien Lifehouse
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Wollongong, New South Wales, Australia, 2500
- Wollongong Hospital
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Queensland
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Greenslopes, Queensland, Australia, 4120
- Greenslopes Private Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Cancer Research South Australia
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Aalst, Belgia, 9300
- Azorg Campus Aalst - Moorselbaan
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Brussels, Belgia, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgia, B-1070
- Institut Jules Bordet
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Brussels, Belgia, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Edegem, Belgia, 2650
- Universitair Ziekenhuis Antwerpen
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Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgia, 9000
- Algemeen Ziekenhuis Maria Middelares
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Mons, Belgia, 7000
- Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
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Yvoir, Belgia, 5530
- Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
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Rio de Janeiro, Brasil, 22250-905
- Oncoclinicas Rio de Janeiro S A
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40170-110
- Hospital Sao Rafael-Idor
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30130-090
- Cenantron Centro Avançado de Tratamento Oncologico Ltda
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Passos, Minas Gerais, Brasil, 37904-020
- Santa Casa de Misericordia de Passos
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Paraná
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Cascavel, Paraná, Brasil, 85806-300
- Hospital Uopeccan
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasil, 98700-000
- Hospital de Clinicas de Ijui
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Passo Fundo, Rio Grande do Sul, Brasil, 99010-260
- Hospital de Clinicas de Passo Fundo
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Porto Alegre, Rio Grande do Sul, Brasil, 90020-090
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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São Paulo
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São Paulo, São Paulo, Brasil, 01509-900
- Fundacao Antonio Prudente AC Camargo Cancer Center
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São Paulo, São Paulo, Brasil, 05652-900
- Hospital Israelita Albert Einstein
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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Quebec
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Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec Hopital de l Enfant Jesus
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Herning, Danmark, 7400
- Regionshospitalet Godstrup
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Odense C, Danmark, 5000
- Odense Universitetshospital
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Alabama
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Mobile, Alabama, Forente stater, 36607
- Infirmary Cancer Center
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California
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Los Angeles, California, Forente stater, 90033
- University of Southern California
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale New Haven Hospital
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Georgia
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Athens, Georgia, Forente stater, 30607
- University Cancer and Blood Center LLC
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Atlanta, Georgia, Forente stater, 30322
- Emory University
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Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois Chicago
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Indiana
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Indianapolis, Indiana, Forente stater, 46237
- Franciscan Health Indianapolis
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Our Lady of the Lake Cancer Institute
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Dana-Farber Cancer Institute
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Michigan
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Grand Rapids, Michigan, Forente stater, 49503
- Cancer and Hematology Centers of Western Michigan
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Saint Paul, Minnesota, Forente stater, 55102
- Allina Health System dba Allina Health Cancer Institute
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Missouri
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Springfield, Missouri, Forente stater, 65807
- Oncology Hematology Associates
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Nebraska
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Omaha, Nebraska, Forente stater, 68130
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, Forente stater, 08816
- Astera Cancer Care
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New Brunswick, New Jersey, Forente stater, 08901
- Rutgers Cancer Institute of New Jersey
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New York
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The Bronx, New York, Forente stater, 10461
- Montefiore Medical Center - Bronx
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- Oncology Hematology Care Incorporated
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University
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Oregon
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Eugene, Oregon, Forente stater, 97401
- Oncology Associates of Oregon, PC
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Forente stater, 38120
- Baptist Cancer Center Memphis Thoracic
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Nashville, Tennessee, Forente stater, 37203
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, Forente stater, 75246
- Texas Oncology - Dallas Fort Worth
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Dallas, Texas, Forente stater, 75246
- US Oncology Research Investigational Products Center
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Houston, Texas, Forente stater, 77030
- University of Texas MD Anderson Cancer Center
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Virginia
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Newport News, Virginia, Forente stater, 23606
- Virginia Oncology Associates
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Richmond, Virginia, Forente stater, 23298
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, Forente stater, 98104
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- The Medical College of Wisconsin
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Bordeaux, Frankrike, 33000
- Institut Bergonie
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Brest, Frankrike, 29200
- Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
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Créteil, Frankrike, 94010
- Centre Hospitalier Intercommunal de Creteil
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Le Mans, Frankrike, 72000
- Centre Hospitalier - Le Mans
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Lyon, Frankrike, 69008
- Centre Leon Berard
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Marseille, Frankrike, 13915
- Centre Hospitalier Universitaire Nord
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Montpellier, Frankrike, 34298
- Institut regional du Cancer Montpellier
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Paris, Frankrike, 75014
- Hopital Cochin
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Saint-Herblain, Frankrike, 44800
- Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
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Strasbourg, Frankrike, 67091
- Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
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Toulouse, Frankrike, 31059
- Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
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Valenciennes, Frankrike, 59300
- Clinique Teissier
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Athens, Hellas, 18547
- Metropolitan Hospital
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Athens, Hellas, 15562
- Metropolitan General
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Athens, Hellas, 12462
- Attikon University Hospital
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Athens, Hellas, 11526
- Henry Dunant Hospital Center
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Athens, Hellas, 11527
- Sotiria General Hospital
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Thessaloniki, Hellas, 55236
- Saint Lukes Hospital SA
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Thessaloniki, Hellas, 57001
- European Interbalkan Medical Center
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Kowloon, Hong Kong
- Princess Margaret Hospital
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Shatin, New Territories, Hong Kong
- Prince of Wales Hospital, Chinese University of Hong Kong
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Dublin, Irland, 9
- Beaumont Hospital
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Haifa, Israel, 3109601
- Rambam Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Bari, Italia, 70124
- IRCCS Istituto Tumori Giovanni Paolo II
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Milan, Italia, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Milan, Italia, 20141
- IRCCS Istituto Oncologico Europeo
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Verona, Italia, 37126
- Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Kurume-shi, Fukuoka, Japan, 830-0011
- Kurume University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Akashi-shi, Hyōgo, Japan, 673-8558
- Hyogo Cancer Center
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
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Niigata
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Niigata, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama-ken
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Okayama, Okayama-ken, Japan, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata-shi, Osaka, Japan, 573-1191
- Kansai Medical University Hospital
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Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Osakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital
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Saitama
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Hidaka-shi, Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Koto-ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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Wakayama
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Wakayama, Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Beijing, Kina, 100142
- Beijing Cancer Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100020
- Beijing Chaoyang Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400037
- Xinqiao Hospital
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Fujian Cancer Hospital
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Quanzhou, Fujian, Kina, 362002
- The Second Attached Hospital Of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Sun Yat-sen University Cancer Center
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Guangxi
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Guilin, Guangxi, Kina, 541001
- Affiliated Hospital of Guilin Medical University
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Nanning, Guangxi, Kina, 530201
- Guangxi Medical University Affiliated Tumor Hospital
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Hebei
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Cangzhou, Hebei, Kina, 061011
- Cangzhou Peoples Hospital
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Heilongjiang
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Jiamusi, Heilongjiang, Kina, 154007
- Jiamusi Cancer Hospital
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Henan
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Zhengzhou, Henan, Kina, 450003
- Henan Cancer Hospital
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Zhengzhou, Henan, Kina, 450066
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Kina, 430070
- Hubei Cancer Hospital
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina, 010010
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- Nanjing Chest Hospital
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Xuzhou, Jiangsu, Kina, 221009
- Xuzhou Central Hospital
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Jiangxi Cancer hospital
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Jilin
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Changchun, Jilin, Kina, 130012
- Jilin Cancer Hospital
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Shandong
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Jinan, Shandong, Kina, 250117
- The Affiliated Cancer Hospital of Shandong First Medical University
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Linyi, Shandong, Kina, 276000
- Linyi Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
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Shanxi
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Taiyuan, Shanxi, Kina, 030009
- Shanxi Provincial Cancer Hospital
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Xi’an, Shanxi, Kina, 710065
- The First Affiliated Hospital of Xian Jiaotong University
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Sichuan
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Chengdu, Sichuan, Kina, 611135
- West China Hospital of Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300121
- Tianjin Peoples Hospital
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Xinjiang
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Ürümqi, Xinjiang, Kina, 830054
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
- the First Affiliated Hospital Zhejiang University School of Medicine
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Ningbo, Zhejiang, Kina, 315010
- The First Affiliated Hospital Of Ningbo University
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Wenzhou, Zhejiang, Kina, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Mexico City
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Mexico City, Mexico City, Mexico, 03810
- Oncare
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Mexico City, Mexico City, Mexico, 03100
- Health Pharma Professional Research SA de CV
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Groningen, Nederland, 9713 GZ
- Universitair Medisch Centrum Groningen
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Maastricht, Nederland, 6229 HX
- Maastricht Universitair Medisch Centrum
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Rotterdam, Nederland, 3015 GD
- Erasmus Medisch Centrum
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Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
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Poznan, Polen, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
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Warsaw, Polen, 01-138
- Instytut Gruzlicy i Chorob Pluc
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Wroclaw, Polen, 53-439
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
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Lisbon, Portugal, 1500-650
- Hospital da Luz, SA
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Lisbon, Portugal, 1998-018
- Hospital Cuf Descobertas
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Matosinhos Municipality, Portugal, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Porto, Portugal, 4100-180
- Hospital Cuf porto
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Cluj-Napoca, Romania, 400015
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
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Ploieşti, Romania, 100337
- Spitalul Municipal Ploiesti
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Madrid, Spania, 28034
- Hospital Universitario Ramon y Cajal
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Andalusia
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Málaga, Andalusia, Spania, 29011
- Hospital Regional Universitario de Malaga
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Seville, Andalusia, Spania, 41009
- Hospital Universitario Virgen Macarena
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Catalonia
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Barcelona, Catalonia, Spania, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, Catalonia, Spania, 08035
- Hospital Universitari Vall d Hebron
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Barcelona, Catalonia, Spania, 08041
- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Catalonia, Spania, 08908
- Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
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Navarre
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Pamplona, Navarre, Spania, 31008
- Clinica Universidad de Navarra
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Valencia
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Valencia, Valencia, Spania, 46026
- Hospital Universitari i Politecnic La Fe
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Basel, Sveits, 4052
- Universitaetsspital Basel
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Bern, Sveits, 3010
- Inselspital Bern
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Mendrisio, Sveits, 6850
- Ospedale Regionale di Bellinzona e Vali
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Sankt Gallen, Sveits, 9007
- Kantonsspital Sankt Gallen
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-
-
-
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Cheongju Chungbuk, Sør -Korea, 28644
- Chungbuk National University Hospital
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Goyang-si Gyeonggi-do, Sør -Korea, 10408
- National Cancer Center
-
Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
-
Seoul, Sør -Korea, 05505
- Asan Medical Center
-
Seoul, Sør -Korea, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, Sør -Korea, 06351
- Samsung Medical Center
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-
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-
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Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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-
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Brno, Tsjekkia, 625 00
- Fakultni nemocnice Brno
-
Olomouc, Tsjekkia, 779 00
- Fakultni nemocnice Olomouc
-
Ostrava-Vitkovice, Tsjekkia, 703 00
- Nemocnice Agel Ostrava-Vitkovice as
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Prague, Tsjekkia, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Prague, Tsjekkia, 150 06
- Fakultni nemocnice v Motole
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-
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Ankara, Tyrkia (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Tyrkia (Türkiye), 34214
- Bagcilar Medipol Mega Universite Hastanesi
-
Izmir, Tyrkia (Türkiye), 35150
- Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
-
Mersin, Tyrkia (Türkiye), 33200
- Medical Park Seyhan Hastanesi
-
Mersin, Tyrkia (Türkiye), 33200
- VM Medical Park Mersin Hastanesi
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Sakarya, Tyrkia (Türkiye), 54290
- Sakarya Egitim ve Arastirma Hastanesi
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-
-
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Cologne, Tyskland, 51109
- Kliniken der Stadt Koeln gGmbH
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Dresden, Tyskland, 01307
- Universitaetsklinikum Dresden
-
Essen, Tyskland, 45147
- Universitaetsklinikum Essen
-
Gauting, Tyskland, 82130
- Asklepios Fachkliniken Muenchen Gauting
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Großhansdorf, Tyskland, 22927
- LungenClinic Grosshansdorf GmbH
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Heidelberg, Tyskland, 69126
- Universitaetsklinikum Heidelberg
-
Münster, Tyskland, 48149
- University Hospital Muenster
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Würzburg, Tyskland, 97078
- Universitaetsklinikum Wuerzburg
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-
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Budapest, Ungarn, 1083
- Semmelweis Egyetem
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Budapest, Ungarn, 1121
- Orszagos Koranyi Pulmonologiai Intezet
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Gyöngyös, Ungarn, 3200
- Matrai Gyogyintezet
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Győr, Ungarn, 9024
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
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Székesfehérvár, Ungarn, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
-
Törökbálint, Ungarn, 2045
- Reformatus Pulmonologiai Centrum
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-
-
-
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Graz, Østerrike, 8036
- Medizinische Universitaet Graz
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Krems, Østerrike, 3500
- Universitaetsklinikum Krems
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Rankweil, Østerrike, 6830
- Landeskrankenhaus Feldkirch
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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 til 99 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
- Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
- Adequate organ function.
- Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is > 6 months since the end of previous therapy and progression, in discussion with the medical monitor.
Exclusion
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- History of other malignancy within the past 2 years, with some exceptions as per protocol.
- Active or prior documented autoimmune or inflammatory disorders as per protocol.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within 28 days of first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
- Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
- Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- Treatment in an alternative investigational trial within 28 days prior to enrollment.
- Has received or is planning to receive consolidative chest radiation for extensive stage disease.
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
- Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
- Female participants planning to become pregnant or donate eggs while on study as per protocol.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol.
- Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
- Male participants unwilling to abstain from donating sperm during treatment as per protocol.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. Participants who are unable to complete clinical outcome assessments are eligible.
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: Tarlatamab in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W). |
Intravenous (IV) infusion
Andre navn:
IV infusion |
|
Aktiv komparator: Durvalumab Alone
Participants will receive durvalumab Q4W alone. |
IV infusion |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
OS
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
OS på 2 år
Tidsramme: 2 år
|
2 år
|
|
Progresjonsfri overlevelse (PFS)
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Samlet respons (OR)
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Disease Control (DC) Rate
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Varighet av respons (DoR)
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
PFS ved 6 måneder
Tidsramme: 6 måneder
|
6 måneder
|
|
PFS ved 1 år
Tidsramme: 1 år
|
1 år
|
|
PFS ved 2 år
Tidsramme: 2 år
|
2 år
|
|
OS ved 6 måneder
Tidsramme: 6 måneder
|
6 måneder
|
|
OS på 1 år
Tidsramme: 1 år
|
1 år
|
|
OS på 3 år
Tidsramme: 3 år
|
3 år
|
|
Tid til progresjon (TTP)
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med behandlingsfremkomne bivirkninger (TEAE)
Tidsramme: Opptil ca 9 måneder
|
Opptil ca 9 måneder
|
|
Antall deltakere med TEAEs grad 3 eller høyere i henhold til Common Terminology Criteria for Adverse Events (CTCAE) versjon 5.0.
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med alvorlige TEAE
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med TEAE som fører til seponering av behandling
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med dødelige TEAE
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med behandlingsrelaterte bivirkninger (AE)
Tidsramme: Opptil ca 9 måneder
|
Opptil ca 9 måneder
|
|
Antall deltakere med uønskede hendelser av interesse (EOI)
Tidsramme: Opptil ca 9 måneder
|
Opptil ca 9 måneder
|
|
Serumkonsentrasjoner av Tarlatamab
Tidsramme: Dag 1 opptil ca. 6 måneder
|
Dag 1 opptil ca. 6 måneder
|
|
Antall deltakere med antitarlatamab-antistoffdannelse
Tidsramme: Opptil ca 9 måneder
|
Opptil ca 9 måneder
|
|
Tid til første forverring (TTD) for fysisk funksjon målt med European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Tidsramme: Baseline til uke 13 og uke 25
|
Baseline til uke 13 og uke 25
|
|
Endring i sykdomssymptomer på hoste målt ved bruk av EORTC-QLQ LC13
Tidsramme: Baseline til uke 13 og uke 25
|
Baseline til uke 13 og uke 25
|
|
Endring i sykdomssymptomer på brystsmerte målt med EORTC-QLQ LC13
Tidsramme: Baseline til uke 13 og uke 25
|
Baseline til uke 13 og uke 25
|
|
Endring i sykdomssymptomer på dyspné målt ved bruk av EORTC-QLQ LC13
Tidsramme: Baseline til uke 13 og uke 25
|
Baseline til uke 13 og uke 25
|
|
TTD for global helsetilstand målt med EORTC-QLQ-C30
Tidsramme: Utgangspunkt til uke 13 og uke 25
|
Utgangspunkt til uke 13 og uke 25
|
|
TTD for livskvalitet målt med EORTC-QLQ-C30
Tidsramme: Baseline til uke 13 og uke 25
|
Baseline til uke 13 og uke 25
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: MD, Amgen
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.
Generelle publikasjoner
- Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.
- Perol M, Yoshida T, Ahn MJ, Gay CM, Schuler M, Liu H, Sezer A, Bilici A, Korantzis I, Lim SM, Otsubo K, Juan-Vidal O, Chen Y, Schvartsman G, Wang H, Dingemans AC, Clarke JM, Desai A, Marigil M, Chen Y, Abidi B, Wang J, Sands J; DeLLphi-305 Investigators. Tarlatamab-Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2026 Oct 24. doi: 10.1056/NEJMoa2609482. Online ahead of print.
Hjelpsomme linker
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)
5. juni 2024
Primær fullføring (Antatt)
2. april 2030
Studiet fullført (Antatt)
2. april 2030
Datoer for studieregistrering
Først innsendt
8. januar 2024
Først innsendt som oppfylte QC-kriteriene
8. januar 2024
Først lagt ut (Faktiske)
18. januar 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20200041
- 2023-505989-29 (Annen identifikator: EU CT Number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Tilgangskriterier for IPD-deling
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .