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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2029-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small-cell Lung Cancer Extensive Stage Small-cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tarlatamab + Durvalumab + Carboplatin + Etoposide

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

Group Type EXPERIMENTAL

Tarlatamab

Intervention Type DRUG

Tarlatamab will be administered as an intravenous (IV) infusion.

Durvalumab

Intervention Type DRUG

Durvalumab will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Etoposide

Intervention Type DRUG

Etoposide will be administered as an IV infusion.

Durvalumab + Carboplatin + Etoposide

Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

Group Type ACTIVE_COMPARATOR

Durvalumab

Intervention Type DRUG

Durvalumab will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Etoposide

Intervention Type DRUG

Etoposide will be administered as an IV infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tarlatamab

Tarlatamab will be administered as an intravenous (IV) infusion.

Intervention Type DRUG

Durvalumab

Durvalumab will be administered as an IV infusion.

Intervention Type DRUG

Carboplatin

Carboplatin will be administered as an IV infusion.

Intervention Type DRUG

Etoposide

Etoposide will be administered as an IV infusion.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMG 757 Imdelltra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saint Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status RECRUITING

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, United States

Site Status RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

University of Illinois Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status RECRUITING

Cancer Center of Kansas, Heritage Plaza Medical Building

Wichita, Kansas, United States

Site Status RECRUITING

Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota, United States

Site Status RECRUITING

Kaiser Permanente Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status RECRUITING

Swedish Cancer Institute Medical Oncology

Seattle, Washington, United States

Site Status RECRUITING

West Virginia University Health Sciences Center

Morgantown, West Virginia, United States

Site Status RECRUITING

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Site Status RECRUITING

Monash Medical Centre

Clayton, Victoria, Australia

Site Status RECRUITING

Medizinische Universitaet Graz

Graz, , Austria

Site Status RECRUITING

Universitaetsklinikum Krems

Krems, , Austria

Site Status RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

Site Status RECRUITING

AZ Delta Campus Rumbeke

Roeselare, , Belgium

Site Status RECRUITING

Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, , Belgium

Site Status RECRUITING

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The Second Attached Hospital Of Fujian Medical University

Quanzhou, Fujian, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Jiangxi Cancer hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Tianjin Peoples Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

Fujian Cancer Hospital

Fuzhou, , China

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Regionshospitalet Godstrup

Herning, , Denmark

Site Status RECRUITING

Centre Hospitalier Intercommunal de Creteil

Créteil, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Centre Hospitalier Universitaire Nord

Marseille, , France

Site Status RECRUITING

Institut Curie

Paris, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Saint-Herblain, , France

Site Status RECRUITING

Hopital d instruction des armees sainte anne

Toulon, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, , France

Site Status RECRUITING

Klinikum Chemnitz GmbH

Chemnitz, , Germany

Site Status RECRUITING

Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Dresden

Dresden, , Germany

Site Status RECRUITING

Krankenhaus Nordwest

Frankfurt am Main, , Germany

Site Status RECRUITING

Asklepios Fachkliniken Muenchen Gauting

Gauting, , Germany

Site Status RECRUITING

LungenClinic Grosshansdorf GmbH

Großhansdorf, , Germany

Site Status RECRUITING

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, , Germany

Site Status RECRUITING

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, , Germany

Site Status RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Henry Dunant Hospital Center

Athens, , Greece

Site Status RECRUITING

Alexandra Hospital

Athens, , Greece

Site Status RECRUITING

European Interbalkan Medical Center

Thessaloniki, , Greece

Site Status RECRUITING

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, , Greece

Site Status RECRUITING

Queen Mary Hospital, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, , Hong Kong

Site Status RECRUITING

Matrai Gyogyintezet

Gyöngyös, , Hungary

Site Status RECRUITING

Reformatus Pulmonologiai Centrum

Törökbálint, , Hungary

Site Status RECRUITING

IRCCS Istituto Tumori Giovanni Paolo II

Bari, , Italy

Site Status RECRUITING

Humanitas Gavazzeni

Bergamo, , Italy

Site Status RECRUITING

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), , Italy

Site Status RECRUITING

IRCCS Istituto Oncologico Europeo

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliera San Giovanni Addolorata

Roma, , Italy

Site Status RECRUITING

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, , Italy

Site Status RECRUITING

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Site Status RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

Site Status RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, Japan

Site Status RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Site Status RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status RECRUITING

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Site Status RECRUITING

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Site Status RECRUITING

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Site Status RECRUITING

Maastricht Universitair Medisch Centrum

Maastricht, , Netherlands

Site Status RECRUITING

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status RECRUITING

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, , Poland

Site Status RECRUITING

Instytut Gruzlicy i Chorob Pluc

Warsaw, , Poland

Site Status RECRUITING

Hospital Cuf Tejo

Lisbon, , Portugal

Site Status RECRUITING

Hospital da Luz, SA

Lisbon, , Portugal

Site Status RECRUITING

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Site Status RECRUITING

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju Chungbuk, , South Korea

Site Status RECRUITING

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Site Status RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Universitaetsspital Basel

Basel, , Switzerland

Site Status RECRUITING

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status RECRUITING

Hopitaux universitaires de Geneve

Geneva, , Switzerland

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Brazil China Denmark France Germany Greece Hong Kong Hungary Italy Japan Netherlands Poland Portugal Romania South Korea Spain Switzerland Taiwan Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amgen Call Center

Role: CONTACT

866-572-6436

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20240178

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of AZD2811 + Durvalumab in ES-SCLC
NCT04745689 ACTIVE_NOT_RECRUITING PHASE2