Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
NCT ID: NCT06211036
Last Updated: 2025-12-17
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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ACTIVE_NOT_RECRUITING
PHASE3
563 participants
INTERVENTIONAL
2024-06-05
2028-09-30
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 in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Tarlatamab
Intravenous (IV) infusion
Durvalumab
IV infusion
Durvalumab Alone
Participants will receive durvalumab Q4W alone.
Durvalumab
IV infusion
Interventions
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Tarlatamab
Intravenous (IV) infusion
Durvalumab
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years (or \>= legal adult age within the country if it is older than 18 years).
* Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
* Minimum life expectancy \> 12 weeks.
* Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
* Adequate organ function.
* Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (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. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is \> 6 months since the end of previous therapy and progression, in discussion with the medical monitor.
Exclusion
* Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* History of other malignancy within the past 2 years, with some exceptions as per protocol.
* Active or prior documented autoimmune or inflammatory disorders as per protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months of first dose of study treatment.
* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
* Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* Major surgical procedures within 28 days of first dose of study treatment.
* Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen \[HBsAg\] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
* History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
* Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
* Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
* Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Treatment in an alternative investigational trial within 28 days prior to enrollment.
* Has received or is planning to receive consolidative chest radiation for extensive stage disease.
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
* Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
* Female participants planning to become pregnant or donate eggs while on study as per protocol.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
* Male participants unwilling to abstain from donating sperm during treatment as per protocol.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. Participants who are unable to complete clinical outcome assessments are eligible.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Infirmary Cancer Center
Mobile, Alabama, United States
University of Southern California
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Illinois Chicago
Chicago, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Allina Health System dba Allina Health Cancer Institute
Saint Paul, Minnesota, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Montefiore Medical Center - Bronx
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Oncology Hematology Care Incorporated
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oncology Associates of Oregon, PC
Eugene, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Cancer Center Memphis Thoracic
Memphis, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States
US Oncology Research Investigational Products Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires
CABA, Buenos Aires, Argentina
Instituto Alexander Fleming
Capital Federal, Buenos Aires, Argentina
Fundacion Medica de Rio Negro y Neuquen
Cipolletti, Río Negro Province, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, Argentina
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
La Rioja, , Argentina
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Medizinische Universitaet Graz
Graz, , Austria
Universitaetsklinikum Krems
Krems, , Austria
Landeskrankenhaus Feldkirch
Rankweil, , Austria
Azorg Campus Aalst - Moorselbaan
Aalst, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, , Belgium
Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
Mons, , Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, , Belgium
Hospital Sao Rafael-Idor
Salvador, Estado de Bahia, Brazil
Cenantron Centro Avançado de Tratamento Oncologico Ltda
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericordia de Passos
Passos, Minas Gerais, Brazil
Hospital Uopeccan
Cascavel, Paraná, Brazil
Hospital de Clinicas de Ijui
Ijuí, Rio Grande do Sul, Brazil
Hospital de Clinicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
São Paulo, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, , Brazil
London Health Sciences Centre
London, Ontario, Canada
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, Canada
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Second Attached Hospital Of Fujian Medical University
Quanzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Cangzhou Peoples Hospital
Cangzhou, Hebei, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Nanjing Chest Hospital
Nanjing, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Cancer hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Peoples Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
the First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Nemocnice Agel Ostrava-Vitkovice as
Ostrava-Vitkovice, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
Regionshospitalet Godstrup
Herning, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Centre Hospitalier - Le Mans
Le Mans, , France
Centre Leon Berard
Lyon, , France
Centre Hospitalier Universitaire Nord
Marseille, , France
Institut regional du Cancer Montpellier
Montpellier, , France
Hopital Cochin
Paris, , France
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Saint-Herblain, , France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, , France
Clinique Teissier
Valenciennes, , France
Kliniken der Stadt Koeln gGmbH
Cologne, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, , Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
University Hospital Muenster
Münster, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Henry Dunant Hospital Center
Athens, , Greece
Sotiria General Hospital
Athens, , Greece
Attikon University Hospital
Athens, , Greece
Metropolitan General
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
Saint Lukes Hospital SA
Thessaloniki, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Princess Margaret Hospital
Kowloon, , Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, , Hong Kong
Semmelweis Egyetem
Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest, , Hungary
Matrai Gyogyintezet
Gyöngyös, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, , Hungary
Beaumont Hospital
Dublin, , Ireland
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
IRCCS Istituto Oncologico Europeo
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, , Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
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
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 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
Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, Mexico
Oncare
Mexico City, Mexico City, Mexico
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Poznan, , Poland
Instytut Gruzlicy i Chorob Pluc
Warsaw, , Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, , Poland
Hospital da Luz, SA
Lisbon, , Portugal
Hospital Cuf Descobertas
Lisbon, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Hospital Cuf porto
Porto, , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Municipal Ploiesti
Ploieşti, , Romania
Chungbuk National University Hospital
Cheongju Chungbuk, , South Korea
National Cancer Center
Goyang-si Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, 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
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Universitaetsspital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Ospedale Regionale di Bellinzona e Vali
Mendrisio, , Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
Izmir, , Turkey (Türkiye)
Medical Park Seyhan Hastanesi
Mersin, , Turkey (Türkiye)
VM Medical Park Mersin Hastanesi
Mersin, , Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, , Turkey (Türkiye)
Countries
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References
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Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-505989-29
Identifier Type: OTHER
Identifier Source: secondary_id
20200041
Identifier Type: -
Identifier Source: org_study_id