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A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
NCT07005128 · Amgen
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
About this study
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
Eligibility criteria
Inclusion Criteria:
* Participant has provided informed consent before initiation of any study-specific activities/procedures.
* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
* Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV 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.
* Measurable disease as defined per RECIST 1.1.
* Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
* Minimum life expectancy ≥ 12 weeks.
Exclusion Criteria:
* Participants can have no history of other malignancy in the last 2 years.
* Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
* They will have no history of severe or life-threatening events to immune-mediated therapy.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
* They will have no active autoimmune or inflammatory disorders.
* Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
* Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
Study design
Enrollment target: 330 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-18
Estimated completion: 2029-07-15
Last updated: 2026-04-16
Interventions
Drug: TarlatamabDrug: DurvalumabDrug: CarboplatinDrug: Etoposide
Primary outcomes
- • Overall Survival (OS) (Up to approximately 3.5 years)
- • Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) (Up to approximately 3.5 years)
Sponsor
Amgen · industry
With: AstraZeneca
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (148)
City of Hope Cancer Center PhoenixRecruiting
Goodyear, Arizona, United States
Saint Bernards Medical CenterRecruiting
Jonesboro, Arkansas, United States
Translational Research in Oncology US Inc, Trio Central PharmacyRecruiting
Los Angeles, California, United States
University of California Los AngelesRecruiting
Santa Monica, California, United States
Presbyterian Intercommunity Hospital Health Whitter HospitalRecruiting
Whittier, California, United States
Colorado West Healthcare System dba Grand Valley OncologyRecruiting
Grand Junction, Colorado, United States
Yale New Haven HospitalRecruiting
New Haven, Connecticut, United States
Orlando Health Cancer InstituteRecruiting
Kissimmee, Florida, United States
City of Hope AtlantaRecruiting
Newnan, Georgia, United States
University of Illinois ChicagoRecruiting
Chicago, Illinois, United States
Cancer Care Specialists of IllinoisRecruiting
Decatur, Illinois, United States
City of Hope ChicagoRecruiting
Rockford, Illinois, United States
Indiana University Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
Cancer Center of Kansas, Heritage Plaza Medical BuildingRecruiting
Wichita, Kansas, United States
New England Cancer SpecialistsRecruiting
Westbrook, Maine, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Allina Health System dba Allina Health Cancer InstituteRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Cancer Partners of NebraskaRecruiting
Lincoln, Nebraska, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Oncology Hematology Care, IncRecruiting
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Willamette Valley Cancer Institute and Research Center - EugeneRecruiting
Eugene, Oregon, United States
Kaiser Permanente Medical CenterRecruiting
Portland, Oregon, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
United States Oncology Regulatory Affairs Corporate OfficeRecruiting
Nashville, Tennessee, United States
Texas OncologyRecruiting
Dallas, Texas, United States
Oncology ConsultantsRecruiting
Houston, Texas, United States
US Oncology Research Investigational Products CenterRecruiting
Irving, Texas, United States
Texas Oncology Northeast TexasRecruiting
Tyler, Texas, United States
Virginia Cancer Specialists PCRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Swedish Cancer Institute Medical OncologyRecruiting
Seattle, Washington, United States
Northwest Medical Specialties, PLLCRecruiting
Tacoma, Washington, United States
West Virginia University Health Sciences CenterRecruiting
Morgantown, West Virginia, United States
CemicRecruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario AustralRecruiting
Pilar, Buenos Aires, Argentina
Sanatorio Parque SARecruiting
Rosario, Santa Fe Province, Argentina
Chris OBrien LifehouseRecruiting
Camperdown, New South Wales, Australia
Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Medizinische Universitaet GrazRecruiting
Graz, Austria
Universitaetsklinikum KremsRecruiting
Krems, Austria
Jessa Ziekenhuis - Campus Virga JesseRecruiting
Hasselt, Belgium
Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
Leuven, Belgium
AZ Delta Campus RumbekeRecruiting
Roeselare, Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site GodinneRecruiting
Yvoir, Belgium
Cenantron Centro Avançado de Tratamento Oncologico LtdaRecruiting
Belo Horizonte, Minas Gerais, Brazil
Liga Norte-Riograndense Contra O CancerRecruiting
Natal, Rio Grande do Norte, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fund Faculdade Regional Med Sao Jose Rio PretoRecruiting
São José do Rio Preto, São Paulo, Brazil
Centro de Pesquisa do Hospital Albert EinsteinRecruiting
São Paulo, São Paulo, Brazil
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
The Second Attached Hospital Of Fujian Medical UniversityRecruiting
Quanzhou, Fujian, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Jiamusi Cancer HospitalRecruiting
Jiamusi, Heilongjiang, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Jiangxi Cancer hospitalRecruiting
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Shandong Cancer HospitalRecruiting
Jinan, Shandong, China
Shanghai Chest HospitalRecruiting
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary HospitalRecruiting
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer HospitalRecruiting
Taiyuan, Shanxi, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Tianjin Cancer HospitalRecruiting
Tianjin, Tianjin Municipality, China
Tianjin Peoples HospitalRecruiting
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China
Beijing Cancer HospitalRecruiting
Beijing, China
Fujian Cancer HospitalRecruiting
Fuzhou, China
RigshospitaletRecruiting
Copenhagen, Denmark
Regionshospitalet GodstrupRecruiting
Herning, Denmark
Centre Hospitalier Intercommunal de CreteilRecruiting
Créteil, France
Centre Leon BerardRecruiting
Lyon, France
Centre Hospitalier Universitaire NordRecruiting
Marseille, France
Institut CurieRecruiting
Paris, France
Centre Hospitalier Universitaire de Nantes - Hopital Nord LaennecRecruiting
Saint-Herblain, France
Hopital d instruction des armees sainte anneRecruiting
Toulon, France
Centre Hospitalier Universitaire de Toulouse - Hopital LarreyRecruiting
Toulouse, France
Klinikum Chemnitz GmbHRecruiting
Chemnitz, Germany
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbHRecruiting
Cologne, Germany
Universitaetsklinikum DresdenRecruiting
Dresden, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Krankenhaus NordwestRecruiting
Frankfurt am Main, Germany
Asklepios Fachkliniken Muenchen GautingRecruiting
Gauting, Germany
LungenClinic Grosshansdorf GmbHRecruiting
Großhansdorf, Germany
Universitaetsklinikum Schleswig-Holstein - KielRecruiting
Kiel, Germany
Universitaetsklinikum Schleswig-Holstein - LuebeckRecruiting
Lübeck, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
Henry Dunant Hospital CenterRecruiting
Athens, Greece
Alexandra HospitalRecruiting
Athens, Greece
European Interbalkan Medical CenterRecruiting
Thessaloniki, Greece
Iatriko Diavalkaniko ThessalonikisRecruiting
Thessaloniki, Greece
Queen Mary Hospital, The University of Hong KongRecruiting
Hong Kong, Hong Kong
Prince of Wales Hospital, Chinese University of Hong KongRecruiting
Shatin, New Territories, Hong Kong
Matrai GyogyintezetRecruiting
Gyöngyös, Hungary
Reformatus Pulmonologiai CentrumRecruiting
Törökbálint, Hungary
Meir Medical CenterRecruiting
Kfar Saba, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
IRCCS Istituto Tumori Giovanni Paolo IIRecruiting
Bari, Italy
Humanitas GavazzeniRecruiting
Bergamo, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino AmadoriRecruiting
Meldola (FC), Italy
IRCCS Istituto Oncologico EuropeoRecruiting
Milan, Italy
Azienda Ospedaliera San Giovanni AddolorataRecruiting
Roma, Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitataRecruiting
Verona, Italy
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Ehime, Japan
Kyushu University HospitalRecruiting
Fukuoka, Fukuoka, Japan
Kurume University HospitalRecruiting
Kurume-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer CenterRecruiting
Sapporo, Hokkaido, Japan
Hyogo Cancer CenterRecruiting
Akashi-shi, Hyōgo, Japan
Niigata Cancer Center HospitalRecruiting
Niigata, Niigata, Japan
Okayama University HospitalRecruiting
Okayama, Okayama-ken, Japan
Kansai Medical University HospitalRecruiting
Hirakata-shi, Osaka, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Osaka, Japan
Kindai University HospitalRecruiting
Sakai-shi, Osaka, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka-shi, Saitama, Japan
Shizuoka Cancer CenterRecruiting
Sunto-gun, Shizuoka, Japan
Wakayama Medical University HospitalRecruiting
Wakayama, Wakayama, Japan
Universitair Medisch Centrum GroningenRecruiting
Groningen, Netherlands
Maastricht Universitair Medisch CentrumRecruiting
Maastricht, Netherlands
Erasmus Medisch CentrumRecruiting
Rotterdam, Netherlands
Centrum Pulmonologii i Torakochirurgii w BystrejRecruiting
Bystra, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Instytut Gruzlicy i Chorob PlucRecruiting
Warsaw, Poland
Hospital Cuf TejoRecruiting
Lisbon, Portugal
Hospital da Luz, SARecruiting
Lisbon, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro HispanoRecruiting
Matosinhos Municipality, Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-NapocaRecruiting
Cluj-Napoca, Romania
Chungbuk National University HospitalRecruiting
Cheongju Chungbuk, South Korea
National Cancer CenterRecruiting
Goyang-si Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Hospital Regional Universitario de MalagaRecruiting
Málaga, Andalusia, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de BarcelonaRecruiting
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Catalonia, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Madrid, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Valencia, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Universitaetsspital BaselRecruiting
Basel, Switzerland
Kantonsspital GraubuendenRecruiting
Chur, Switzerland
Hopitaux universitaires de GeneveRecruiting
Geneva, Switzerland
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Memorial Ankara HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Bagcilar Medipol Mega Universite HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi HastanesiRecruiting
Izmir, Turkey (Türkiye)
Sakarya Egitim ve Arastirma HastanesiRecruiting
Sakarya, Turkey (Türkiye)