RecruitingPhase 3NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

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)

Sponsor

Amgen

Enrollment

330 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

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).

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment combinations for extensive-stage small-cell lung cancer (ES-SCLC): one group receives tarlatamab (a newer immunotherapy), durvalumab, carboplatin, and etoposide, while the other receives just durvalumab, carboplatin, and etoposide as standard first-line treatment. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have extensive-stage small-cell lung cancer (spread beyond the chest) - You have measurable tumors on imaging - Your doctor believes you are suitable to receive the standard chemotherapy/immunotherapy regimen - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have had another cancer in the last 2 years - You have active or symptomatic brain metastases - You have a history of severe reactions to immunotherapy - You have had a stroke or blood clot in an artery within the last 6 months - You have an active autoimmune condition, active HIV, or active hepatitis B or C - You have interstitial lung disease or active pneumonitis - You have had a solid organ transplant - You have had a recent heart attack or severe heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

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

DRUGDurvalumab

Durvalumab will be administered as an IV infusion.

DRUGCarboplatin

Carboplatin will be administered as an IV infusion.

DRUGEtoposide

Etoposide will be administered as an IV infusion.

Locations(150)

City of Hope Cancer Center Phoenix

Goodyear, Arizona, United States

Saint Bernards Medical Center

Jonesboro, Arkansas, United States

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, United States

University of California Los Angeles

Santa Monica, California, United States

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, United States

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Orlando Health Cancer Institute

Kissimmee, Florida, United States

City of Hope Atlanta

Newnan, Georgia, United States

University of Illinois Chicago

Chicago, Illinois, United States

Cancer Care Specialists of Illinois

Decatur, Illinois, United States

City of Hope Chicago

Rockford, 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

New England Cancer Specialists

Westbrook, Maine, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Minnesota Oncology Hematology PA

Edina, Minnesota, United States

Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Oncology Hematology Care, Inc

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, United States

Kaiser Permanente Medical Center

Portland, Oregon, United States

Baptist Cancer Center

Memphis, Tennessee, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Texas Oncology

Dallas, Texas, United States

Oncology Consultants

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Texas Oncology Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Swedish Cancer Institute Medical Oncology

Seattle, Washington, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

West Virginia University Health Sciences Center

Morgantown, West Virginia, United States

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, 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

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

AZ Delta Campus Rumbeke

Roeselare, Belgium

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

Yvoir, Belgium

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, Brazil

Centro de Pesquisa do Hospital Albert Einstein

São Paulo, 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

Universitaetsklinikum Essen

Essen, 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

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

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

Kindai University Hospital

Sakai-shi, 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

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 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 Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 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)

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NCT07005128