Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) (DeLLphi-306)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Tarlatamab

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122AAL
    • Instituto Argentino de Diagnostico y Tratamiento
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundación Respirar
    • La Plata, Buenos Aires, Argentina, 1900
      • Hospital Italiano de La Plata
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 5003
      • Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo
  • Distrito Federal
    • CABA, Distrito Federal, Argentina, C1118AAT
      • Hospital Aleman Buenos Aires
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500ACE
      • Clínica Viedma
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Sanatorio 9 de Julio Cice 9 de Julio
• Australia
  • New South Wales
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Vienna, Austria, 1090
    • Universitaetsklinikum Allgemeines Krankenhaus Wien
• Belgium
  • Brussels, Belgium, B-1070
    • Institut Jules Bordet
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto Dor de Pesquisa E Ensino
  • São Paulo, Brazil, 01246-000
    • Instituto Cancer Sao Paulo Icesp
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29043-260
      • Hospital Santa Rita
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Oncoclinicas Onco Vida Distrito Federal
  • Paraná
    • Curitba, Paraná, Brazil, 81520-060
      • Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
    • Londrina, Paraná, Brazil, 86015-520
      • Londrina Cancer Hospital
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Liga Norte-Riograndense Contra O Cancer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Cipo - Centro Integrado de Pesquisa em Oncologia
    • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96835-090
      • Centro de pesquisa em oncologia Hospital Ana Nery
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89015-200
      • Centro Catarinense de Pesquisa LTDA
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundacao pio xII Barretos
    • Jaú, São Paulo, Brazil, 17210-120
      • Fundacao Amaral Carvalho
    • Santo André, São Paulo, Brazil, 09060-650
      • Cepho
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center Plovdiv EOOD
  • Shumen, Bulgaria, 9700
    • Complex Oncology Center Shumen EOOD
  • Sofia, Bulgaria, 1527
    • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
  • Sofia, Bulgaria, 1113
    • University Multiprofile Hospital for Active Treatment Sofiamed OOD
  • Sofia, Bulgaria, 1632
    • Multiprofile Hospital for Active Treatment Serdikamed EOOD
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430070
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225009
      • Northern Jiangsu Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Cancer Hospital of Shandong First Medical University
    • Qingdao, Shandong, China, 266000
      • Qingdao Municipal Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China, 030009
      • Shanxi Provincial Cancer Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin cancer hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • The first affiliated hospital of Xinjiang medical university
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315016
      • Ningbo medical center lihuili hospital
    • Taizhou, Zhejiang, China, 317099
      • Zhejiang Taizhou Hospital
• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0129
      • Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC
    • Bogota, Cundinamarca, Colombia, 111711
      • Instituto Nacional de Cancerologia
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia
      • Instituto Medico de Alta Tecnologia sas - Imat sas
  • Risaralda Department
    • Pereira, Risaralda Department, Colombia, 660001
      • Oncologos del Occidente SAS
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 681017
      • Fundacion Cardiovascular de Colombia
• France
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
  • Marseille, France, 13915
    • Centre Hospitalier Universitaire Nord
  • Nice, France, 06002
    • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Villefranche-sur-Saône, France, 69400
    • Hopital Nord Ouest Villefranche sur Saone
• Germany
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Göttingen, Germany, 37075
    • Universitaetsmedizin Goettingen
  • Würzburg, Germany, 97078
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens, Greece, 18547
    • Metropolitan Hospital
  • Athens, Greece, 15562
    • Metropolitan General
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center
  • Athens, Greece, 11527
    • Sotiria General Hospital
  • Athens, Greece, 11522
    • Agios Savvas Anticancer Hospital
  • Athens, Greece, 12462
    • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
  • Thessaloniki, Greece, 57001
    • European Interbalkan Medical Center
  • Thessaloniki, Greece, 55236
    • Saint Luke Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital, Chinese University of Hong Kong
• Italy
  • Aviano PN, Italy, 33081
    • Centro di Riferimento Oncologico di Aviano
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20141
    • IRCCS Istituto Oncologico Europeo
  • Orbassano, Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana
  • Reggio Emilia, Italy, 42123
    • Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
  • Rozzano MI, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
  • Statte, Italy, 74010
    • Ospedale San Giuseppe Moscati
• Japan
  • Wakayama, Japan, 641-8509
    • Wakayama Medical University Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Miyagi
    • Sendai, Miyagi, Japan, 981-0914
      • Sendai Kousei Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Osaka, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Saitama
    • Hidaka-Shi, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Mexico
  • Puebla City, Mexico, 72530
    • Oncocenter Clinica Integral Internacional de Oncologia
  • Toluca, Mexico, 50090
    • Phylasis Clinicas Research Toluca
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06760
      • Centro Oncologico Personalizado
    • Mexico City, Mexico City, Mexico, 03810
      • Oncare
• Poland
  • Bialystok, Poland, 15-540
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Bystra, Poland, 43-360
    • Centrum Pulmonologii i Torakochirurgii w Bystrej
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Lublin, Poland, 20-090
    • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
  • Prabuty, Poland, 82-550
    • Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia
  • Przemyśl, Poland, 37-700
    • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
• Portugal
  • Braga, Portugal, 4710-243
    • Unidade Local de Saude de Braga, EPE
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, SA
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
• Romania
  • Balotesti, Ilfov, Romania, 077015
    • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
  • Bucharest, Romania, 022328
    • Institutul Oncologic, Prof Dr Alexandru Trestioreanu
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
  • Craiova, Romania, 200542
    • Centrul de Oncologie Sf Nectarie SRL
  • Iași, Romania, 700483
    • Institutul Regional de Oncologie Iasi
  • Ploieşti, Romania, 100337
    • Spitalul Municipal Ploiesti
  • Timișoara, Romania, 300239
    • SC Oncomed SRL
• Singapore
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
  • Singapore, Singapore, 217562
    • Icon - Mount Alvernia
• South Korea
  • Cheongju Chungbuk, South Korea, 28644
    • Chungbuk National University Hospital
  • Goyang-si Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Incheon, South Korea, 405-760
    • Gachon University Gil Medical Center
  • Jinju, South Korea, 52727
    • Gyeongsang National University Hospital
  • Seongnam-si, Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seongnam-si, Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center, CHA University
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 110-744
    • Seoul National University Hospital
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañón
  • Andalusia
    • Málaga, Andalusia, Spain, 29011
      • Hospital Regional Universitario de Malaga
    • Seville, Andalusia, Spain, 41013
      • Hospital Universitario Virgen del Rocio
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Clinico Universitario Lozano Blesa
  • Canary Islands
    • Las Palmas de Gran Canaria, Canary Islands, Spain, 35016
      • Hospital Universitario Insular de Gran Canaria
  • Catalonia
    • Badalona, Catalonia, Spain, 08916
      • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
    • Barcelona, Catalonia, Spain, 08003
      • Hospital del Mar
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic i Provincial de Barcelona
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall d Hebron
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Hospital Clinico Universitario de Santiago
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
  • Valencia
    • Valencia, Valencia, Spain, 46009
      • Instituto Valenciano de Oncología
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset
  • Umeå, Sweden, 901 85
    • Norrlands Universitetssjukhus
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Basel, Switzerland, 4052
    • Universitaetsspital Basel
  • Mendrisio, Switzerland, 6850
    • Ospedale Regionale di Bellinzona e Vali
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
  • Ankara, Turkey (Türkiye), 06200
    • Ankara Etlik Şehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34214
    • Bagcilar Medipol Mega Universite Hastanesi
  • Istanbul, Turkey (Türkiye), 34890
    • Marmara Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35575
    • Izmir Ekonomi Universitesi Medical Point Hastanesi
  • Izmir, Turkey (Türkiye), 35110
    • Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi Hastanesi
  • Mersin, Turkey (Türkiye), 33200
    • Medical Park Seyhan Hastanesi
  • Samsun, Turkey (Türkiye), 55200
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guys Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital
• United States
  • California
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Plantation, Florida, United States, 33322
      • Boca Raton Clinical Research Global South Florida
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville James Graham Brown Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Cancer Institute
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University Grossman School of Medicine and New York University Langone Hospitals
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center at New York University Langone Hospital - Long Island
    • The Bronx, New York, United States, 10461
      • Montefiore Einstein Center for Cancer Care
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Easton, Pennsylvania, United States, 18045
      • Spokenword Clinical Trials
  • Texas
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
    • The Woodlands, Texas, United States, 77380
      • US Oncology Research Investigational Products Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: -Participants are eligible to be included in the study only if all of the following criteria apply:

• Participant has provided informed consent prior to 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 confirmed small-cell lung cancer (SCLC).
• Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
• Has completed chemoradiotherapy without progression per RECIST 1.1 (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]).
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.
• Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.

Exclusion Criteria: -Participants are excluded from the study if any of the following criteria apply:

Disease Related

• Extensive-stage SCLC (ES-SCLC).
• Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
• Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
• History of other malignancy within the past 2 years, with certain exceptions.
• History of solid organ transplantation.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
• Exclusion of human immunodeficiency virus (HIV) or active hepatitis infection based on criteria per protocol.
• 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.

Prior/Concomitant Therapy

• Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
• Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
• Prior history of severe or life-threatening events from any immune-mediated therapy.
• Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
• Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
• Major surgical procedures within 28 days prior to first dose of study treatment.
• Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

Other Exclusions

• Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.
• Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
• Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
• 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 and for an additional 60 days after the last dose of study treatment.
• Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.
• Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
• Participant has known sensitivity to any of the products or components to be administered during dosing.
• Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
• History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tarlatamab; Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).	Drug: Tarlatamab; Intravenous (IV) infusion; Other Names: AMG 757
Placebo Comparator: Placebo; Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).	Drug: Placebo; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS as Determined by BICR	Up to approximately 6 years
OS Over the Whole Trial	Up to approximately 6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
PFS Determined by Investigator Assessment	Up to approximately 6 years
PFS at 6 months, 1 year, 2 years	6 months, 1 year, 2 years
OS at 6 months, 1 year, 2 years, 3 years	6 months, 1 year, 2 years, 3 years
Time to Progression (TTP)	Up to approximately 6 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to approximately 6 years
Serum Concentration of Tarlatamab	Up to approximately 4 months
Incidence of Anti-tarlatamab Antibody Formation	Up to approximately 1 year
Complete Response (CR) Rate	Up to approximately 6 years
CR + non-CR/non-Progressive Disease (PD) Rate	Up to approximately 6 years
Duration of Complete Response	Up to approximately 6 years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): April 20, 2030
• Study Completion (Estimated): April 20, 2030

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer; SCLC; AMG 757; Tarlatamab; Limited Stage Small Cell Lung Cancer; LS SCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Substandard Drugs; Pharmaceutical Preparations; AMG 757
• Other Study ID Numbers: 20230016; 2023-506235-15 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No