A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
NCT ID: NCT07005128
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
330 participants
INTERVENTIONAL
2025-08-18
2029-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tarlatamab + Durvalumab + Carboplatin + Etoposide
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an IV infusion.
Carboplatin
Carboplatin will be administered as an IV infusion.
Etoposide
Etoposide will be administered as an IV infusion.
Durvalumab + Carboplatin + Etoposide
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Durvalumab
Durvalumab will be administered as an IV infusion.
Carboplatin
Carboplatin will be administered as an IV infusion.
Etoposide
Etoposide will be administered as an IV infusion.
Interventions
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Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an IV infusion.
Carboplatin
Carboplatin will be administered as an IV infusion.
Etoposide
Etoposide will be administered as an IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Saint Bernards Medical Center
Jonesboro, Arkansas, United States
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Illinois Chicago
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Cancer Center of Kansas, Heritage Plaza Medical Building
Wichita, Kansas, United States
Allina Health System dba Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Kaiser Permanente Medical Center
Portland, Oregon, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Swedish Cancer Institute Medical Oncology
Seattle, Washington, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Parque SA
Rosario, Santa Fe Province, Argentina
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Medizinische Universitaet Graz
Graz, , Austria
Universitaetsklinikum Krems
Krems, , Austria
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
AZ Delta Campus Rumbeke
Roeselare, , Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, , Belgium
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil
Fund Faculdade Regional Med Sao Jose Rio Preto
São José do Rio Preto, São Paulo, Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Second Attached Hospital Of Fujian Medical University
Quanzhou, Fujian, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangxi Cancer hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Peoples Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Fujian Cancer Hospital
Fuzhou, , China
Rigshospitalet
Copenhagen, , Denmark
Regionshospitalet Godstrup
Herning, , Denmark
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Centre Leon Berard
Lyon, , France
Centre Hospitalier Universitaire Nord
Marseille, , France
Institut Curie
Paris, , France
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Saint-Herblain, , France
Hopital d instruction des armees sainte anne
Toulon, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, , France
Klinikum Chemnitz GmbH
Chemnitz, , Germany
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH
Cologne, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Krankenhaus Nordwest
Frankfurt am Main, , Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, , Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, , Germany
Universitaetsklinikum Schleswig-Holstein - Luebeck
Lübeck, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Henry Dunant Hospital Center
Athens, , Greece
Alexandra Hospital
Athens, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, , Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, , Hong Kong
Matrai Gyogyintezet
Gyöngyös, , Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, , Hungary
IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
Humanitas Gavazzeni
Bergamo, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), , Italy
IRCCS Istituto Oncologico Europeo
Milan, , Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, , Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, , Italy
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, , Poland
Instytut Gruzlicy i Chorob Pluc
Warsaw, , Poland
Hospital Cuf Tejo
Lisbon, , Portugal
Hospital da Luz, SA
Lisbon, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Chungbuk National University Hospital
Cheongju Chungbuk, , South Korea
National Cancer Center
Goyang-si Gyeonggi-do, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Universitaetsspital Basel
Basel, , Switzerland
Kantonsspital Graubuenden
Chur, , Switzerland
Hopitaux universitaires de Geneve
Geneva, , Switzerland
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20240178
Identifier Type: -
Identifier Source: org_study_id
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