Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
December 12, 2025 updated by: Amgen
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Study Overview
Status
Status
Active, not recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
563
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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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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Graz, Austria, 8036
- Medizinische Universitaet Graz
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Krems, Austria, 3500
- Universitaetsklinikum Krems
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Rankweil, Austria, 6830
- Landeskrankenhaus Feldkirch
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Aalst, Belgium, 9300
- Azorg Campus Aalst - Moorselbaan
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Brussels, Belgium, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgium, B-1070
- Institut Jules Bordet
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Brussels, Belgium, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Edegem, Belgium, 2650
- Universitair Ziekenhuis Antwerpen
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Genk, Belgium, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgium, 9000
- Algemeen Ziekenhuis Maria Middelares
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Mons, Belgium, 7000
- Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
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Yvoir, Belgium, 5530
- Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
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Rio de Janeiro, Brazil, 22250-905
- Oncoclinicas Rio de Janeiro S A
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 40170-110
- Hospital Sao Rafael-Idor
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130-090
- Cenantron Centro Avançado de Tratamento Oncologico Ltda
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Passos, Minas Gerais, Brazil, 37904-020
- Santa Casa de Misericórdia de Passos
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Paraná
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Cascavel, Paraná, Brazil, 85806-300
- Hospital Uopeccan
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Hospital de Clinicas de Ijui
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Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
- Hospital de Clínicas de Passo Fundo
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Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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São Paulo
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São Paulo, São Paulo, Brazil, 01509-900
- Fundacao Antonio Prudente AC Camargo Cancer Center
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São Paulo, São Paulo, Brazil, 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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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100020
- Beijing Chaoyang Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400037
- Xinqiao Hospital
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Fujian
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Fuzhou, Fujian, China, 350014
- Fujian Cancer Hospital
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Quanzhou, Fujian, China, 362002
- The Second Attached Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-Sen University Cancer Center
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Guangxi
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Guilin, Guangxi, China, 541001
- Affiliated Hospital of Guilin Medical University
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Nanning, Guangxi, China, 530201
- Guangxi Medical University Affiliated Tumor Hospital
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Hebei
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Cangzhou, Hebei, China, 061011
- Cangzhou Peoples Hospital
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Heilongjiang
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Jiamusi, Heilongjiang, China, 154007
- Jiamusi Cancer Hospital
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Henan
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Zhengzhou, Henan, China, 450003
- Henan Cancer Hospital
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Zhengzhou, Henan, China, 450066
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430070
- Hubei Cancer Hospital
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Inner Mongolia
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Hohhot, Inner Mongolia, China, 010010
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Nanjing Chest Hospital
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Xuzhou, Jiangsu, China, 221009
- Xuzhou Central Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330029
- Jiangxi Cancer Hospital
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Jilin
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Changchun, Jilin, China, 130012
- Jilin Cancer Hospital
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Shandong
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Jinan, Shandong, China, 250117
- The Affiliated Cancer Hospital of Shandong First Medical University
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Linyi, Shandong, China, 276000
- Linyi Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, China, 200030
- Shanghai Chest Hospital
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Shanxi
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Taiyuan, Shanxi, China, 030009
- Shanxi Provincial Cancer Hospital
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Xi’an, Shanxi, China, 710065
- The First Affiliated Hospital of Xian Jiaotong University
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Sichuan
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Chengdu, Sichuan, China, 611135
- West China Hospital of Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300121
- Tianjin Peoples Hospital
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Xinjiang
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Ürümqi, Xinjiang, China, 830054
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Ningbo, Zhejiang, China, 315010
- The first affiliated hospital of Ningbo university
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Wenzhou, Zhejiang, China, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Brno, Czechia, 625 00
- Fakultní Nemocnice Brno
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc
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Ostrava-Vitkovice, Czechia, 703 00
- Nemocnice Agel Ostrava-Vitkovice as
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Prague, Czechia, 128 08
- Vseobecna Fakultni nemocnice v Praze
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Prague, Czechia, 150 06
- Fakultni nemocnice v Motole
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Herning, Denmark, 7400
- Regionshospitalet Godstrup
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Odense C, Denmark, 5000
- Odense Universitetshospital
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Bordeaux, France, 33000
- Institut Bergonie
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Brest, France, 29200
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
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Créteil, France, 94010
- Centre Hospitalier Intercommunal de Créteil
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Le Mans, France, 72000
- Centre Hospitalier - Le Mans
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Lyon, France, 69008
- Centre Leon Berard
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Marseille, France, 13915
- Centre Hospitalier Universitaire Nord
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Montpellier, France, 34298
- Institut regional du Cancer Montpellier
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Paris, France, 75014
- Hopital Cochin
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Saint-Herblain, France, 44800
- Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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Strasbourg, France, 67091
- Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
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Toulouse, France, 31059
- Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
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Valenciennes, France, 59300
- Clinique Teissier
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Cologne, Germany, 51109
- Kliniken der Stadt Koeln gGmbH
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Dresden, Germany, 01307
- Universitaetsklinikum Dresden
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Essen, Germany, 45147
- Universitaetsklinikum Essen
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Gauting, Germany, 82130
- Asklepios Fachkliniken Muenchen Gauting
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Großhansdorf, Germany, 22927
- LungenClinic Grosshansdorf GmbH
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Heidelberg, Germany, 69126
- Universitaetsklinikum Heidelberg
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Münster, Germany, 48149
- University Hospital Muenster
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Würzburg, Germany, 97078
- Universitaetsklinikum Wuerzburg
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Athens, Greece, 18547
- Metropolitan Hospital
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Athens, Greece, 15562
- Metropolitan General
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Athens, Greece, 12462
- Attikon University Hospital
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Athens, Greece, 11526
- Henry Dunant Hospital Center
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Athens, Greece, 11527
- Sotiria General Hospital
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Thessaloniki, Greece, 55236
- Saint Lukes Hospital SA
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Thessaloniki, Greece, 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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Budapest, Hungary, 1083
- Semmelweis Egyetem
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Budapest, Hungary, 1121
- Országos Korányi Pulmonológiai Intézet
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Gyöngyös, Hungary, 3200
- Mátrai Gyógyintézet
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Győr, Hungary, 9024
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
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Székesfehérvár, Hungary, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
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Törökbálint, Hungary, 2045
- Reformatus Pulmonologiai Centrum
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Dublin, Ireland, 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, Italy, 70124
- IRCCS Istituto Tumori Giovanni Paolo II
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Milan, Italy, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Milan, Italy, 20141
- IRCCS Istituto Oncologico Europeo
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Verona, Italy, 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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Mexico City
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Mexico City, Mexico City, Mexico, 03100
- Health Pharma Professional Research SA de CV
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Mexico City, Mexico City, Mexico, 03810
- Oncare
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Groningen, Netherlands, 9713 GZ
- Universitair Medisch Centrum Groningen
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Maastricht, Netherlands, 6229 HX
- Maastricht Universitair Medisch Centrum
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Rotterdam, Netherlands, 3015 GD
- Erasmus Medisch Centrum
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Gdansk, Poland, 80-214
- Uniwersyteckie Centrum Kliniczne
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Poznan, Poland, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
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Warsaw, Poland, 01-138
- Instytut Gruzlicy i Chorob Pluc
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Wroclaw, Poland, 53-439
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
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Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
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Lisbon, Portugal, 1500-650
- Hospital da Luz, SA
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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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Cheongju Chungbuk, South Korea, 28644
- Chungbuk National University Hospital
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Goyang-si Gyeonggi-do, South Korea, 10408
- National Cancer Center
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 05505
- Asan Medical Center
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Seoul, South Korea, 03722
- Severance Hospital Yonsei University Health System
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Seoul, South Korea, 06351
- Samsung Medical Center
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Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal
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Andalusia
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Málaga, Andalusia, Spain, 29011
- Hospital Regional Universitario de Malaga
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Seville, Andalusia, Spain, 41009
- Hospital Universitario Virgen Macarena
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Catalonia
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Barcelona, Catalonia, Spain, 08041
- Hospital de La Santa Creu I Sant Pau
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Barcelona, Catalonia, Spain, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, Catalonia, Spain, 08035
- Hospital Universitari Vall D Hebron
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L'Hospitalet de Llobregat, Catalonia, Spain, 08908
- Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
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Navarre
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Pamplona, Navarre, Spain, 31008
- Clinica Universidad de Navarra
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Valencia
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Valencia, Valencia, Spain, 46026
- Hospital Universitari I Politècnic La Fe
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Basel, Switzerland, 4052
- Universitaetsspital Basel
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Bern, Switzerland, 3010
- Inselspital Bern
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Mendrisio, Switzerland, 6850
- Ospedale Regionale di Bellinzona e Vali
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Sankt Gallen, Switzerland, 9007
- Kantonsspital Sankt Gallen
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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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Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi
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Istanbul, Turkey (Türkiye), 34214
- Bagcilar Medipol Mega Universite Hastanesi
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Izmir, Turkey (Türkiye), 35150
- Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
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Mersin, Turkey (Türkiye), 33200
- Medical Park Seyhan Hastanesi
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Mersin, Turkey (Türkiye), 33200
- VM Medical Park Mersin Hastanesi
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Sakarya, Turkey (Türkiye), 54290
- Sakarya Egitim ve Arastirma Hastanesi
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Alabama
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Mobile, Alabama, United States, 36607
- Infirmary Cancer Center
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
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Georgia
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Athens, Georgia, United States, 30607
- University Cancer and Blood Center LLC
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Atlanta, Georgia, United States, 30322
- Emory University
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Chicago
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Indiana
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Indianapolis, Indiana, United States, 46237
- Franciscan Health Indianapolis
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Our Lady of the Lake Cancer Institute
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Cancer and Hematology Centers of Western Michigan
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Saint Paul, Minnesota, United States, 55102
- Allina Health System dba Allina Health Cancer Institute
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Missouri
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Springfield, Missouri, United States, 65807
- Oncology Hematology Associates
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Nebraska
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Omaha, Nebraska, United States, 68130
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, United States, 08816
- Astera Cancer Care
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New Brunswick, New Jersey, United States, 08901
- Rutgers Cancer Institute of New Jersey
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New York
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The Bronx, New York, United States, 10461
- Montefiore Medical Center - Bronx
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care Incorporated
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Oregon
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Eugene, Oregon, United States, 97401
- Oncology Associates Of Oregon, Pc
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, United States, 38120
- Baptist Cancer Center Memphis Thoracic
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology - Dallas Fort Worth
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Dallas, Texas, United States, 75246
- US Oncology Research Investigational Products Center
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Virginia
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Newport News, Virginia, United States, 23606
- Virginia Oncology Associates
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- The Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
2
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Tarlatamab in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
|
IV infusion
Intravenous (IV) infusion
Other Names:
|
|
Active Comparator: Durvalumab Alone
Participants will receive durvalumab Q4W alone.
|
IV infusion
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
OS
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
OS at 2 Years
Time Frame: 2 years
|
2 years
|
|
Progression Free Survival (PFS)
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Overall Response (OR)
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Disease Control (DC) Rate
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Duration of Response (DoR)
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
PFS at 6 Months
Time Frame: 6 months
|
6 months
|
|
PFS at 1 Year
Time Frame: 1 year
|
1 year
|
|
PFS at 2 Years
Time Frame: 2 years
|
2 years
|
|
OS at 6 Months
Time Frame: 6 months
|
6 months
|
|
OS at 1 Year
Time Frame: 1 year
|
1 year
|
|
OS at 3 Years
Time Frame: 3 years
|
3 years
|
|
Time to Progression (TTP)
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Number of Participants with Serious TEAEs
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Number of Participants with TEAEs Leading to Discontinuation of Treatment
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Number of Participants with Fatal TEAEs
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Number of Participants with Treatment-related Adverse Events (AEs)
Time Frame: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Number of Participants with Adverse Events of Interest (EOI)
Time Frame: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Serum Concentrations of Tarlatamab
Time Frame: Day 1 up to approximately 6 months
|
Day 1 up to approximately 6 months
|
|
Number of Participants with Antitarlatamab Antibody Formation
Time Frame: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
|
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
|
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
|
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
|
TTD for Global Health Status as Measured by EORTC-QLQ-C30
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
|
TTD for Quality of Life as Measured by EORTC-QLQ-C30
Time Frame: Baseline to Week 13 and Week 25
|
Baseline to Week 13 and Week 25
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
June 5, 2024
Primary Completion (Estimated)
Primary Completion
July 5, 2027
Study Completion (Estimated)
Study Completion
September 30, 2028
Study Registration Dates
First Submitted
First Submitted
January 8, 2024
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
January 8, 2024
First Posted (Actual)
First Posted
January 18, 2024
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
December 17, 2025
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
December 12, 2025
Last Verified
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20200041
- 2023-505989-29 (Other Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.