New hope for aggressive lung cancer: Immune-Boosting combo trial launches

NCT ID NCT07005128

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether adding the drug tarlatamab to standard chemotherapy and immunotherapy helps people with extensive-stage small-cell lung cancer live longer. About 330 participants will be randomly assigned to receive either the new combination or standard treatment alone. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tarlatamab (a drug that helps the immune system attack cancer cells) combined with durvalumab, carboplatin, and etoposide
What this could lead to: If successful, this could offer a new first-line treatment option that extends survival for people with extensive-stage small-cell lung cancer.
What could go wrong: This is an early-phase 3 trial, so results are not yet known. The added drug may cause more side effects, and the benefit over standard therapy is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

350 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extensive-stage small-cell lung cancer Small cell lung cancer

Contacts and locations

Locations

AZ Delta Campus Rumbeke

Roeselare, 8800, Belgium
Alexandra Hospital

Athens, 11528, Greece
Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States
Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)
Asklepios Fachkliniken Muenchen Gauting

Gauting, 82130, Germany
Azienda Ospedaliera San Giovanni Addolorata

Roma, 00184, Italy
Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)
Baptist Cancer Center

Memphis, Tennessee, 38120, United States
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100080, China
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Cancer Care Specialists of Illinois

Decatur, Illinois, 62526, United States
Cancer Center of Kansas, Heritage Plaza Medical Building

Wichita, Kansas, 67214, United States
Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States
Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, 32256, United States
Cancer and Blood Specialists of Arizona

Casa Grande, Arizona, 85222, United States
Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais, 30130-090, Brazil
Central Georgia Cancer Care PC

Macon, Georgia, 31210, United States
Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France
Centre Hospitalier Universitaire Nord

Marseille, 13915, France
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Saint-Herblain, 44800, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, 5530, Belgium
Centre Leon Berard

Lyon, 69008, France
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, 37126, Italy
Centro de Pesquisa do Hospital Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil
Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43-360, Poland
Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia
Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea
City of Hope Atlanta

Newnan, Georgia, 30265, United States
City of Hope Cancer Center Phoenix

Goodyear, Arizona, 85338, United States
Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, 81505, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States
Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)
Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands
European Interbalkan Medical Center

Thessaloniki, 57001, Greece
Florida Oncology and Hematology

Fort Myers, Florida, 33912, United States
Fujian Cancer Hospital

Fuzhou, 350011, China
Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil
Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

New Britain, Connecticut, 06053, United States
Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States
Health Pharma Professional Research SA de CV

Mexico City, Mexico City, 03100, Mexico
Hematology Oncology Association of Central New York

East Syracuse, New York, 13057, United States
Hematology Oncology of Indiana

Indianapolis, Indiana, 46260, United States
Henan Cancer Hospital

Zhengzhou, Henan, 450003, China
Henry Dunant Hospital Center

Athens, 11526, Greece
Hopital d instruction des armees sainte anne

Toulon, 83800, France
Hopitaux universitaires de Geneve

Geneva, 1211, Switzerland
Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain
Hospital Cuf Tejo

Lisbon, 1350-352, Portugal
Hospital Regional Universitario de Malaga

Málaga, Andalusia, 29010, Spain
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain
Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Austral

Pilar, Buenos Aires, B1629ODT, Argentina
Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital da Luz, SA

Lisbon, 1500-650, Portugal
Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain
Humanitas Gavazzeni

Bergamo, 24125, Italy
Hyogo Cancer Center

Akashi-shi, Hyōgo, 673-8558, Japan
IRCCS Istituto Oncologico Europeo

Milan, 20141, Italy
IRCCS Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy
Iatriko Diavalkaniko Thessalonikis

Thessaloniki, 57001, Greece
Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Institut Curie

Paris, 75005, France
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania
Instytut Gruzlicy i Chorob Pluc

Warsaw, 01-138, Poland
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), 47014, Italy
Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium
Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, 154007, China
Jiangxi Cancer hospital

Nanchang, Jiangxi, 330029, China
Kaiser Permanente Medical Center

Portland, Oregon, 97227, United States
Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan
Kantonsspital Graubuenden

Chur, 7000, Switzerland
Kindai University Hospital

Sakai-shi, Osaka, 590-0197, Japan
Klinikum Chemnitz GmbH

Chemnitz, 09113, Germany
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH

Cologne, 51109, Germany
Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany
Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan
Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan
Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59062-000, Brazil
LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany
Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX, Netherlands
Matrai Gyogyintezet

Gyöngyös, 3200, Hungary
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medizinische Universitaet Graz

Graz, 8036, Austria
Meir Medical Center

Kfar Saba, 4428164, Israel
Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)
Midwestern Regional Medical Center dba City of Hope Chicago

Rockford, Illinois, 61108, United States
Minnesota Oncology Hematology PA

Edina, Minnesota, 55435, United States
Monash Medical Centre

Clayton, Victoria, 3168, Australia
National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea
National Cheng Kung University Hospital

Tainan, 70403, Taiwan
National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan
National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan
Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States
New England Cancer Specialists

Westbrook, Maine, 04092, United States
New York Cancer and Blood Specialists

Shirley, New York, 11967, United States
New York Oncology Hematology PC

Albany, New York, 12206, United States
Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan
Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States
Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan
Oncology Consultants

Houston, Texas, 77030, United States
Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States
Orlando Health Cancer Institute

Kissimmee, Florida, 34744, United States
Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan
Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, 90602, United States
Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong
Providence Saint Jude Medical Center

Fullerton, California, 92835, United States
Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong
Rabin Medical Center

Petah Tikva, 4941492, Israel
Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary
Regionshospitalet Godstrup

Herning, 7400, Denmark
Rigshospitalet

Copenhagen, 2100, Denmark
Saint Bernards Medical Center

Jonesboro, Arkansas, 72401, United States
Saitama Medical University International Medical Center

Hidaka-shi, Saitama, 350-1298, Japan
Sakarya Egitim ve Arastirma Hastanesi

Sakarya, 54290, Turkey (Türkiye)
Sanatorio Parque SA

Rosario, Santa Fe Province, 2000, Argentina
Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea
Shandong Cancer Hospital

Jinan, Shandong, 250117, China
Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China
Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030009, China
Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan
Swedish Cancer Institute Medical Oncology

Seattle, Washington, 98104, United States
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246, United States
Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States
The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330209, China
The Second Attached Hospital Of Fujian Medical University

Quanzhou, Fujian, 362002, China
Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China
Tianjin Peoples Hospital

Tianjin, Tianjin Municipality, 300121, China
Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, 90095, United States
US Oncology Research Investigational Products Center

Irving, Texas, 75063, United States
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal
United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203, United States
Universitaetsklinikum Dresden

Dresden, 01307, Germany
Universitaetsklinikum Essen

Essen, 45147, Germany
Universitaetsklinikum Krems

Krems, 3500, Austria
Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, 24105, Germany
Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, 23538, Germany
Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany
Universitaetsspital Basel

Basel, 4052, Switzerland
Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands
Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of California Los Angeles

Santa Monica, California, 90404, United States
University of Illinois Chicago

Chicago, Illinois, 60612, United States
University of Texas Health Science Center at Tyler

Tyler, Texas, 75701, United States
Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland
Virginia Cancer Specialists PC

Fairfax, Virginia, 22031, United States
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan
West China Hospital of Sichuan University

Chengdu, Sichuan, 611135, China
West Virginia University Health Sciences Center

Morgantown, West Virginia, 26506, United States
Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401, United States
Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

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