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 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20240178
• Study Type: interventional
• Target: 350
• Locations: 25 countries
• Sites: 162

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• PFS (Investigator Assessed)

  Up to approximately 4 years

• Objective Response (OR)

  Up to approximately 4 years

• Disease Control

  Up to approximately 4 years

• Duration of Response (DOR)

  Up to approximately 4 years

• PFS Rate

  6 months, 1 year, and 2 years

Study Arms (2)

Tarlatamab + Durvalumab + Carboplatin + Etoposide

EXPERIMENTAL

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

Drug: Tarlatamab; Drug: Durvalumab; Drug: Carboplatin; Drug: Etoposide

Durvalumab + Carboplatin + Etoposide

ACTIVE COMPARATOR

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

Drug: Durvalumab; Drug: Carboplatin; Drug: Etoposide

Interventions

Tarlatamab DRUG

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

Also known as: AMG 757, Imdelltra

Tarlatamab + Durvalumab + Carboplatin + Etoposide

Durvalumab DRUG

Durvalumab will be administered as an IV infusion.

Durvalumab + Carboplatin + Etoposide; Tarlatamab + Durvalumab + Carboplatin + Etoposide

Carboplatin DRUG

Carboplatin will be administered as an IV infusion.

Durvalumab + Carboplatin + Etoposide; Tarlatamab + Durvalumab + Carboplatin + Etoposide

Etoposide DRUG

Etoposide will be administered as an IV infusion.

Durvalumab + Carboplatin + Etoposide; Tarlatamab + Durvalumab + Carboplatin + Etoposide

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• AstraZeneca: collaborator

Study Sites (164)

Cancer and Blood Specialists of Arizona

Casa Grande, Arizona, 85222, United States

Location

City of Hope Cancer Center Phoenix

Goodyear, Arizona, 85338, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Saint Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Providence Saint Jude Medical Center

Fullerton, California, 92835, United States

Location

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, 90095, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, 90602, United States

Location

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

Location

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

New Britain, Connecticut, 06053, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Florida Oncology and Hematology

Fort Myers, Florida, 33912, United States

Location

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, 32256, United States

Location

Orlando Health Cancer Institute

Kissimmee, Florida, 34744, United States

Location

Central Georgia Cancer Care PC

Macon, Georgia, 31210, United States

Location

City of Hope Atlanta

Newnan, Georgia, 30265, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526, United States

Location

Midwestern Regional Medical Center dba City of Hope Chicago

Rockford, Illinois, 61108, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Hematology Oncology of Indiana

Indianapolis, Indiana, 46260, United States

Location

Cancer Center of Kansas, Heritage Plaza Medical Building

Wichita, Kansas, 67214, United States

Location

New England Cancer Specialists

Westbrook, Maine, 04092, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Minnesota Oncology Hematology PA

Edina, Minnesota, 55435, United States

Location

Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

New York Oncology Hematology PC

Albany, New York, 12206, United States

Location

Hematology Oncology Association of Central New York

East Syracuse, New York, 13057, United States

Location

New York Cancer and Blood Specialists

Shirley, New York, 11967, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401, United States

Location

Kaiser Permanente Medical Center

Portland, Oregon, 97227, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

US Oncology Research Investigational Products Center

Irving, Texas, 75063, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75701, United States

Location

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Swedish Cancer Institute Medical Oncology

Seattle, Washington, 98104, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University Health Sciences Center

Morgantown, West Virginia, 26506, United States

Location

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina

Location

Hospital Universitario Austral

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Sanatorio Parque SA

Rosario, Santa Fe Province, 2000, Argentina

Location

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Universitaetsklinikum Krems

Krems, 3500, Austria

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

AZ Delta Campus Rumbeke

Roeselare, 8800, Belgium

Location

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

Yvoir, 5530, Belgium

Location

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Centro de Pesquisa do Hospital Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100080, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The Second Attached Hospital Of Fujian Medical University

Quanzhou, Fujian, 362002, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, 154007, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Jiangxi Cancer hospital

Nanchang, Jiangxi, 330029, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330209, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030009, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 611135, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Tianjin Peoples Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Fujian Cancer Hospital

Fuzhou, 350011, China

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Regionshospitalet Godstrup

Herning, 7400, Denmark

Location

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Centre Hospitalier Universitaire Nord

Marseille, 13915, France

Location

Institut Curie

Paris, 75005, France

Location

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Saint-Herblain, 44800, France

Location

Hopital d instruction des armees sainte anne

Toulon, 83800, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Klinikum Chemnitz GmbH

Chemnitz, 09113, Germany

Location

Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH

Cologne, 51109, Germany

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

Asklepios Fachkliniken Muenchen Gauting

Gauting, 82130, Germany

Location

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, 24105, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, 23538, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

Location

Henry Dunant Hospital Center

Athens, 11526, Greece

Location

Alexandra Hospital

Athens, 11528, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Location

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, 57001, Greece

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Matrai Gyogyintezet

Gyöngyös, 3200, Hungary

Location

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

IRCCS Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

Location

Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), 47014, Italy

Location

IRCCS Istituto Oncologico Europeo

Milan, 20141, Italy

Location

Azienda Ospedaliera San Giovanni Addolorata

Roma, 00184, Italy

Location

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, 37126, Italy

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Hyogo Cancer Center

Akashi-shi, Hyōgo, 673-8558, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Kindai University Hospital

Sakai-shi, Osaka, 590-0197, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

Location

Health Pharma Professional Research SA de CV

Mexico City, Mexico City, 03100, Mexico

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43-360, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Instytut Gruzlicy i Chorob Pluc

Warsaw, 01-138, Poland

Location

Hospital Cuf Tejo

Lisbon, 1350-352, Portugal

Location

Hospital da Luz, SA

Lisbon, 1500-650, Portugal

Location

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

Matosinhos Municipality, 4464-513, Portugal

Location

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea

Location

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Hospital Regional Universitario de Malaga

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Universitaetsspital Basel

Basel, 4052, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hopitaux universitaires de Geneve

Geneva, 1211, Switzerland

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

Location

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Location

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, 54290, Turkey (Türkiye)

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

AMG 757; durvalumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): August 15, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

IL (2); JP (13); NL (3); BR (5); GR (4); CH (3); TU (6); TW (2); ME (1); AU (2); PL (3); US (50); PT (3); FR (7); HK (2); DK (2); IT (6); ES (8); BE (4); RO (1); CN (17); AR (3); KR (3); HU (2); DE (10)