Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (DeLLphi-304)

A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer (SCLC)
• Intervention / Treatment: Drug: Tarlatamab; Drug: Lurbinectedin; Drug: Topotecan; Drug: Amrubicin

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122AAL
    • Instituto Argentino de Diagnostico y Tratamiento IADT
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
      • CEMIC
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5004BAL
      • Sociedad de Beneficencia Hospital Italiano
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500ACE
      • Clinica Viedma
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Sanatorio Parque SA
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Krems, Austria, 3500
    • Universitaetsklinikum Krems
• Belgium
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Rumbeke
  • Sint-Niklaas, Belgium, 9100
    • VITAZ Campus Sint-Niklaas Moerland
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto Coi
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40050-410
      • Hospital Santa Izabel
    • Salvador, Estado de Bahia, Brazil
      • Instituto de Ensino e Pesquisa do Hospital da Bahia
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Liga Norte-Riograndense Contra O Cancer
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
  • Rondônia
    • Porto Velho, Rondônia, Brazil, 76834-899
      • Hospital de Amor da Amazonia
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • São Paulo, São Paulo, Brazil, 01323-900
      • Beneficencia Portuguesa de Sao Paulo - Bp
    • São Paulo, São Paulo, Brazil, 04502-001
      • Oncologia Rede D Or
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• China
  • Beijing, China, 101149
    • Beijing Chest Hospital, Capital Medical University
  • Fuzhou, China, 350011
    • Fujian Cancer Hospital
  • Tianjin, China, 300131
    • Tianjin Peoples Hospital
  • Weihai, China, 264200
    • Weihai Municipal Hospital
  • Anhui
    • Hefei, Anhui, China, 230022
      • Anhui Chest Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100010
      • Beijing Tongren Hospital Affiliated to Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • The Second Affiliated Hospital of Army Medical University, PLA
    • Chongqing, Chongqing Municipality, China, 400042
      • Army Special Medical Center of Peoples Liberation Army
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350025
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Jiangmen, Guangdong, China, 529030
      • Jiangmen Central Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The 4th Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Affiliated Cancer Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225009
      • Subei Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of NanChang University
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Jinan, Shandong, China, 250117
      • Shandong Tumor Hospital
    • Linyi, Shandong, China, 276034
      • Linyi Cancer Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 30009
      • Shanxi Province Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Taizhou, Zhejiang, China, 317099
      • Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Ostrava-Vitkovice, Czechia, 703 00
    • Nemocnice Agel Ostrava-Vitkovice as
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• France
  • Grenoble, France, 38700
    • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
  • Limoges, France, 87042
    • Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 13915
    • Centre Hospitalier Universitaire Nord
  • Paris, France, 75005
    • Institut Curie
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67091
    • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin, Campus Virchow
  • Cologne, Germany, 50937
    • Universitaetsklinikum Koeln
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Gauting, Germany, 82130
    • Asklepios Fachkliniken Muenchen Gauting
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
  • Würzburg, Germany, 97078
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens, Greece, 11528
    • Alexandra Hospital
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center
  • Athens, Greece, 11527
    • Thoracic General Hospital Of Athens Sotiria
  • Athens, Greece, 11522
    • Saint Savas Hospital
  • Heraklion - Crete, Greece, 71500
    • University Hospital of Heraklion
  • Pátrai, Greece, 26443
    • Olympion Therapeftirio General Clinic Of Patras
  • Thessaloniki, Greece, 57001
    • European Interbalkan Medical Center
  • Thessaloniki, Greece, 55236
    • Saint Luke Hospital
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Pulmonologiai Intezet
  • Gyöngyös, Hungary, 3200
    • Matrai Gyogyintezet
  • Székesfehérvár, Hungary, 8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tatabánya, Hungary, 2800
    • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
  • Törökbálint, Hungary, 2045
    • Reformatus Pulmonologiai Centrum
• Ireland
  • Dublin, Ireland, 9
    • Beaumont Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Ein-Kerem Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
• Italy
  • Bergamo, Italy, 24125
    • Humanitas Gavazzeni
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliera Universitaria Renato Dulbecco
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • Meldola (FC), Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
  • Orbassano, Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Roma, Italy, 00144
    • Azienda Ospedaliera San Giovanni Addolorata
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer 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
  • Hyōgo
    • Akashi-shi, Hyōgo, Japan, 673-8558
      • Hyogo 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
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • 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
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital
• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Hospital Tengku Ampuan Afzan
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital
• Mexico
  • Jalisco
    • Tlajomulco de Zúñiga, Jalisco, Mexico, 45640
      • coi Centro Oncologico Internacional sapi de cv
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • Health Pharma Professional Research SA de CV
    • Mexico City, Mexico City, Mexico, 03810
      • Oncare
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Bystra, Poland, 43-360
    • Centrum Pulmonologii i Torakochirurgii w Bystrej
  • Krakow, Poland, 31-826
    • Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
• Portugal
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, SA
  • Matosinhos Municipality, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  • Porto, Portugal, 4100-180
    • Hospital Cuf porto
• Romania
  • 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
  • Timișoara, Romania, 300239
    • SC Oncomed SRL
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
• South Korea
  • Cheongju Chungbuk, South Korea, 28644
    • Chungbuk National University Hospital
  • Goyang-si Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Hospital
  • Jinju, South Korea, 52727
    • Gyeongsang National University Hospital
  • Seongnam-si, Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • 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, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hospital
• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Andalusia
    • Málaga, Andalusia, Spain, 29011
      • Hospital Regional Universitario de Malaga
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Clínico Universitario Lozano Blesa
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
    • Barcelona, Catalonia, Spain, 08003
      • Hospital Del Mar
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall D Hebron
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Switzerland
  • Chur, Switzerland, 7000
    • Kantonsspital Graubuenden
  • Fribourg, Switzerland, 1708
    • Freiburg Spital
  • Geneva, Switzerland, 1211
    • Hôpitaux Universitaires de Genève
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Veterans General Hospital - Taichung
  • Tainan, Taiwan, 70403
    • National Cheng Kung University 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
  • Denizli, Turkey (Türkiye), 20070
    • Pamukkale Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34214
    • Bagcilar Medipol Mega Universite Hastanesi
  • Izmir, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35575
    • Izmir Ekonomi Universitesi Medical Point Hastanesi
  • Malatya, Turkey (Türkiye), 44280
    • Inonu Universitesi Turgut Ozal Tip Merkezi
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guys Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Mitchell Cancer Institute
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Pikeville, Kentucky, United States, 41501
      • Pikeville Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health Saint Joseph Mercy Ann Arbor
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Cancer Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
  • New Jersey
    • Summit, New Jersey, United States, 91010
      • Summit Medical Group, Overlook Oncology Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • 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
    • Northport, New York, United States, 11768
      • Northport Veterans Affairs Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Roger Maris Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Oncology Clinic and Pharmacy
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center Knoxville
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Edmonds, Washington, United States, 98026
      • Swedish Cancer Institute Medical Oncology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.

Exclusion Criteria:

• Disease Related

  • Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
  • Diagnosis or evidence of leptomeningeal disease.
  • Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.

• Other Medical Conditions

  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
  • History of solid organ transplantation.
  • History of other malignancy within the past 2 years, with exceptions defined in the protocol.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
  • Presence or history of viral infection based on criteria per protocol.
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
  • Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.

• Prior/Concomitant Therapy

  • Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
  • Prior therapy with any selective inhibitor of the DLL3 pathway.
  • Participant received more than one prior systemic therapy regimen for SCLC.
  • Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
  • Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
  • Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
  • Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
  • Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
  • Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
  • Major surgical procedures within 28 days prior to first dose of study treatment.
  • Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
  • Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

• Diagnostic Assessments

  • 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, with exceptions defined in the protocol.

• 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 tarlatamab.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
  • Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening by a 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 tarlatamab.
  • 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 tarlatamab.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
  • Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
  • Participant has known sensitivity or is contraindicated 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.
  • History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tarlatamab; Participants will receive tarlatamab as an intravenous (IV) infusion.	Drug: Tarlatamab; Tarlatamab will be administered as an IV infusion.; Other Names: AMG 757
Active Comparator: Standard of Care; Participants will receive treatment per local standard of care (SOC).	Drug: Lurbinectedin; Lurbinectedin will be administered per local SOC.; Drug: Topotecan; Topotecan will be administered per local SOC.; Drug: Amrubicin; Amrubicin will be administered per local SOC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.	From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as time from randomization until disease progression (PD) or death from any cause, whichever occurs first for all participants. Progression was based on investigator assessment of disease response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: radiologic detection of ≥ 20% increase in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method.	Up to approximately 4 years
Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	The EORTC QLQ-C30 was developed to assess quality of life in cancer participants across tumor types. It was a self-reported, 30-item generic instrument that assessed five functional scales (physical, role, emotional, cognitive, social); nine disease symptom items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties); and a global health status (GHS)/quality of life (QOL) scale. Questionnaire score ranged from 0 to 100. For the functional scales, higher scores indicated high/healthy level of functioning; for the disease symptom scales, higher scores indicated greater symptom burden; and for the GHS/QoL scale, higher scores represented a high QoL. A negative change from baseline indicated reduction in functioning, improvement in symptom burden and reduction in health and quality of life.	Up to approximately 4 years
Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)	The EORTC QLQ-LC13 was a disease-specific supplement to the EORTC QLQ-C30. It included multi-item and single-item measures of lung cancer symptoms (coughing, hemoptysis, dyspnea, pain) and treatment side effects (hair loss, neuropathy, sore mouth, dysphagia). Scores ranged from 0 to 100, with higher scores indicating a greater degree of symptom severity. A negative change from baseline indicated improvement in symptom burden or side effect severity.	Up to approximately 4 years
Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to < 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. 95% CIs were calculated using the Brookmeyer and Crowley method.	Up to approximately 4 years
Disease Control Rate (DCR)	DCR was defined as the percentage of participants documented to have a CR, PR or stable disease (SD) per RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to < 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. SD: Index lesions not meeting the criteria for CR, PR, or PD or the persistence of one or more non-index lesions. Exact 95% CIs were calculated using the Clopper-Pearson method.	Up to approximately 4 years
Duration of Response (DOR)	DOR was defined as the time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first determined by the investigator per RECIST v1.1. Only participants who had achieved OR will be evaluated for DOR. PD: radiologic detection of ≥ 20% increase in in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions.	Up to approximately 4 years
PFS at Year 1	PFS was defined as time from randomization until PD or death from any cause, whichever occurs first for all participants. Progression was based on investigator assessment of disease response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: radiologic detection of ≥ 20% increase in in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method.	1 year
OS at Year 1, 2 and 3	OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% CIs were calculated using the Brookmeyer and Crowley method.	1 year, 2 years and 3 years
Number of Participants With Anti-tarlatamab Antibodies	Incidence of treatment emergent adverse events including grade ≥ 3 treatment emergent adverse events, serious treatment emergent adverse events, treatment emergent adverse events leading to treatment discontinuation, fatal treatment emergent adverse events, and treatment-related treatment emergent adverse events.	Up to approximately 4 years
Trough Concentration (Ctrough) of Tarlatamab	Blood samples were collected for measurement of serum concentrations of tarlatamab.	Up to 1 year
Number of Participants Who Experienced Anti-tarlatamab Antibodies		Up to 1 year
Change From Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)	The BPI-SF (Pain) was a valid and reliable instrument, which was a commonly used tool to capture severity of pain and its impact on daily functioning. The BPI-SF measured intensity of pain at four time points (worst, least, average, and right now), pain relief, and seven interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Scoring for pain ranged from 0 (no pain) to 10 (worst pain), and for pain interference from 0 (no interference) to 10 (complete interference). A negative change from baseline indicated a reduction in pain severity or interference.	Up to approximately 4 years
Change From Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire	PGIS was used to measure a patient's perceived severity of symptoms. PGIS scale asked respondents to describe the severity of their symptoms, overall status, etc, over the past week. The 4-level PGIS response options were: 1: none, 2: mild, 3: moderate, and 4: severe. Higher scores indicated severe condition. A negative change from baseline indicated an improvement in severity.	Up to approximately 4 years
Change From Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire	PGIC measures were used in the measurement of within-patient meaningful change (response) thresholds for disease symptoms/impacts of interest. The PGIC scale asked respondents to rate the overall change in symptoms, overall status, etc., since initiating treatment with the medication. The 5-level PGIC response options were: 1: much better, 2: a little better, 3: about the same, 4: a little worse, and 5: much worse. Higher scores indicated worsening condition. A negative change from baseline indicated an improvement in symptoms.	Up to approximately 4 years
Summary Scores of Patient-perceived Health at Each Assessment Visit Using the Visual Analogue Scale (VAS) as Measured by the 5-Level EuroQol-5 Dimension (EQ-5D-5L)	The EQ5D-5L questionnaire was a standardized instrument used as a measure of health outcome developed by the EuroQol group. It was comprised of a 5-dimension health status measure and a VAS. The 5-dimension health status measure evaluated: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicated worse health status. The VAS recorded the participant's self-rated health on a vertical VAS where the endpoints were labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranged from 0 to 100. Higher scores indicated better perceived health.	Up to approximately 4 years
Change From Baseline in Patient Perceived Health Using VAS Score as Measured by EQ5D-5L	The EQ5D-5L questionnaire was a standardized instrument used as a measure of health outcome developed by the EuroQol group. It was comprised of a 5-dimension health status measure and a VAS. The 5-dimension health status measure evaluated: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicated worse health status. The VAS recorded the participant's self-rated health on a vertical VAS where the endpoints were labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranged from 0 to 100. Higher scores indicated better Perceived health. A negative change from baseline indicated a reduction in better perceived health.	Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)	PRO-CTCAE was a 78-item library used to measure patient-reported symptomatic adverse events. Users selected items that were most relevant to the disease, treatment profile, and fit for purpose to document patients' experience. Each symptom was rated by up to 3 attributes: presence/frequency, severity, and/or interference of the adverse event. Based on the safety profile of tarlatamab and SOC therapy, the study included the following symptoms: shivering or shaking chills, anxiety, constipation, taste changes, vomiting, headache, concentration, rash, palpitations, arm or leg swelling, nausea, dizziness, bruising, fatigue, and decreased appetite, which were deemed relevant for the site of cancer as well as cancer treatment. Responses were typically scored on a 5-point ordinal scale, with values ranging from 0 to 4. Higher scores indicated greater symptom burden.	Up to approximately 4 years
Change From Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire	FACT-G was a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients: physical, social, emotional, and functional well-being. The GP5 of the FACT-G was a single item: "I am bothered by side effects of treatment", rated on a 5-point Likert scale from 0: not at all to 4: very much. Higher scores indicated greater impact of side effects. A negative change from baseline indicated improvement in impact of side effects.	Up to approximately 4 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gumus M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazieres J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2.
• Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): January 29, 2025
• Study Completion (Estimated): March 26, 2028

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer; SCLC; AMG 757; Tarlatamab
• 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; Heterocyclic Compounds; Camptothecin; Alkaloids; AMG 757; Topotecan; PM 01183; amrubicin
• Other Study ID Numbers: 20210004

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