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AzTrials

Small Cell Lung Cancer (SCLC)Phase 3DeLLphi-304NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

A Phase 3 study testing Tarlatamab, Lurbinectedin and Topotecan in people with Small Cell Lung Cancer (SCLC), run by Amgen at 223 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer (SCLC)
What is being tested?
Tarlatamab, Lurbinectedin and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
509 participants
Where
223 sitesin 31 countries
Study dates
31 May 2023to 26 Mar 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 43Show fewer
  • 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..

Trial locations and contacts

223 sites in 31 countries.

223 sites in 31 countries

China33 sites

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100010

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Affiliated Hospital of Army Medical University, PLA

    Chongqing, Chongqing Municipality, 400037

  • Army Special Medical Center of Peoples Liberation Army

    Chongqing, Chongqing Municipality, 400042

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • Fujian Cancer Hospital

    Fuzhou, 350011

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • Anhui Chest Hospital

    Hefei, Anhui, 230022

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shandong Tumor Hospital

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, Shandong, 276034

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • The 4th Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shanxi Province Cancer Hospital

    Taiyuan, Shanxi, 30009

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • Tianjin Peoples Hospital

    Tianjin, 300131

  • Weihai Municipal Hospital

    Weihai, 264200

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Subei Peoples Hospital

    Yangzhou, Jiangsu, 225009

Other trials in China

United States25 sites

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

  • Trinity Health Saint Joseph Mercy Ann Arbor

    Ann Arbor, Michigan, 48106

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • Swedish Cancer Institute Medical Oncology

    Edmonds, Washington, 98026

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58102

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Tennessee Medical Center Knoxville

    Knoxville, Tennessee, 37920

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York, New York, 10016

  • Perlmutter Cancer Center at New York University Langone Hospital----Long Island

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Northport Veterans Affairs Medical Center

    Northport, New York, 11768

  • Pikeville Medical Center

    Pikeville, Kentucky, 41501

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 57104

  • Summit Medical Group, Overlook Oncology Center

    Summit, New Jersey, 91010

Other trials in United States

Japan20 sites

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, 673-8558

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Saitama Medical University International Medical Center

    Hidaka-Shi, Saitama, 350-1298

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Sendai Kousei Hospital

    Sendai, Miyagi, 981-0914

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Brazil11 sites

  • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital de Amor da Amazonia

    Porto Velho, Rondônia, 76834-899

  • Instituto Coi

    Rio de Janeiro, 22793-080

  • Hospital Santa Izabel

    Salvador, Estado de Bahia, 40050-410

  • Instituto de Ensino e Pesquisa do Hospital da Bahia

    Salvador, Estado de Bahia

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Beneficencia Portuguesa de Sao Paulo - Bp

    São Paulo, São Paulo, 01323-900

  • Oncologia Rede D Or

    São Paulo, São Paulo, 04502-001

  • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

    São Paulo, 01246-000

Other trials in Brazil

France11 sites

  • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

    Grenoble, 38700

  • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

    Lille, 59037

  • Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69008

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915

  • Institut Curie

    Paris, 75005

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Gachon University Gil Hospital

    Incheon, 21565

  • Gyeongsang National University Hospital

    Jinju, 52727

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Spain10 sites

  • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

    A Coruña, Galicia, 15006

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

Turkey (Türkiye)9 sites

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Pamukkale Universitesi Tip Fakultesi Hastanesi

    Denizli, 20070

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280

Other trials in Turkey (Türkiye)

Germany8 sites

  • Charite Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82130

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Greece8 sites

  • Saint Savas Hospital

    Athens, 11522

  • Henry Dunant Hospital Center

    Athens, 11526

  • Thoracic General Hospital Of Athens Sotiria

    Athens, 11527

  • Alexandra Hospital

    Athens, 11528

  • University Hospital of Heraklion

    Heraklion - Crete, 71500

  • Olympion Therapeftirio General Clinic Of Patras

    Pátrai, 26443

  • Saint Luke Hospital

    Thessaloniki, 55236

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Argentina7 sites

  • Instituto Argentino de Diagnostico y Tratamiento IADT

    Buenos Aires, C1122AAL

  • Cemic

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • Sociedad de Beneficencia Hospital Italiano

    Córdoba, Córdoba Province, X5004BAL

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

  • Sanatorio Parque SA

    Rosario, Santa Fe Province, 2000

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, 1121

  • Matrai Gyogyintezet

    Gyöngyös, 3200

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045

Other trials in Hungary

Italy6 sites

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC), 47014

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00144

Other trials in Italy

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Nemocnice Agel Ostrava-Vitkovice as

    Ostrava-Vitkovice, 703 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Switzerland5 sites

  • Kantonsspital Graubuenden

    Chur, 7000

  • Freiburg Spital

    Fribourg, 1708

  • Hopitaux universitaires de Geneve

    Geneva, 1211

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

  • Kantonsspital Winterthur

    Winterthur, 8401

Other trials in Switzerland

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Veterans General Hospital - Taichung

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia4 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Belgium4 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • AZ Delta Campus Rumbeke

    Roeselare, 8800

  • Vitaz campus Sint-Niklaas Moerland

    Sint-Niklaas, 9100

Other trials in Belgium

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Netherlands4 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal4 sites

  • Hospital da Luz, SA

    Lisbon, 1500-650

  • Hospital Cuf Descobertas

    Lisbon, 1998-018

  • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

  • Hospital Cuf porto

    Porto, 4100-180

Other trials in Portugal

Romania4 sites

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200542

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Malaysia3 sites

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

Other trials in Malaysia

Mexico3 sites

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100

  • Oncare

    Mexico City, Mexico City, 03810

  • coi Centro Oncologico Internacional sapi de cv

    Tlajomulco de Zúñiga, Jalisco, 45640

Other trials in Mexico

Poland3 sites

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra, 43-360

  • Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

    Krakow, 31-826

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

    Poznan, 60-569

Other trials in Poland

United Kingdom3 sites

  • University College London Hospital

    London, NW1 2PG

  • Guys Hospital

    London, SE1 9RT

  • Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Universitaetsklinikum Krems

    Krems, 3500

Other trials in Austria

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Singapore2 sites

  • National Cancer Centre Singapore

    Singapore, 168583

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Ireland1 site

  • Beaumont Hospital

    Dublin, 9

Other trials in Ireland

About this study

Official title: 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).

Being tested
Tarlatamab, Lurbinectedin, Topotecan, Amrubicin
Keywords
Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    Also called AMG 757

    Tarlatamab will be administered as an IV infusion.

  • LurbinectedinDrug

    Lurbinectedin will be administered per local SOC.

  • TopotecanDrug

    Topotecan will be administered per local SOC.

  • AmrubicinDrug

    Amrubicin will be administered per local SOC.

Study groups in NCT05740566
Study groupRoleWhat they receive
TarlatamabExperimentalParticipants will receive tarlatamab as an intravenous (IV) infusion.
Receives: Drug: Tarlatamab
Standard of CareActive comparatorParticipants will receive treatment per local standard of care (SOC).
Receives: Drug: Lurbinectedin; Drug: Topotecan; Drug: Amrubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (18)

  1. 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.

    Measured: Up to approximately 4 years

  2. 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.

    Measured: Up to approximately 4 years

  3. 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.

    Measured: Up to approximately 4 years

  4. 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.

    Measured: Up to approximately 4 years

  5. 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.

    Measured: Up to approximately 4 years

  6. 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.

    Measured: Up to approximately 4 years

  7. 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.

    Measured: 1 year

  8. 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.

    Measured: 1 year, 2 years and 3 years

  9. 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.

    Measured: Up to approximately 4 years

  10. Trough Concentration (Ctrough) of Tarlatamab

    Blood samples were collected for measurement of serum concentrations of tarlatamab.

    Measured: Up to 1 year

  11. Number of Participants Who Experienced Anti-tarlatamab Antibodies

    Measured: Up to 1 year

  12. 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.

    Measured: Up to approximately 4 years

  13. 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.

    Measured: Up to approximately 4 years

  14. 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.

    Measured: Up to approximately 4 years

  15. 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.

    Measured: Up to approximately 4 years

  16. 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.

    Measured: Up to approximately 4 years

  17. 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.

    Measured: Up to approximately 4 years

  18. 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.

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start31 May 2023
  3. Primary completion29 Jan 2025
  4. Study completion26 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740566
Sponsor's protocol ID
20210004
Acronym
DeLLphi-304
Status last verified
Nov 2025
First submitted
7 Feb 2023
Last updated
5 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Expanded access
Available

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.

    PubMed 40454646

  • Dirnberger F, Patel S, Boyne DJ, Lan Z, Uyei J, Wang J, Cho S, DeCosta L, Bridges IM, Tapan U. Matching-Adjusted Indirect Comparison of Tarlatamab for Patients with Platinum-Refractory or Platinum-Resistant Extensive-Stage Small-Cell Lung Cancer. Adv Ther. 2026 Sep;43(9):4282-4298. doi: 10.1007/s12325-026-03659-4. Epub 2026 Jun 30.

    PubMed 42377743

  • 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.

    PubMed 39530627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarlatamab, Lurbinectedin and Topotecan in people with Small Cell Lung Cancer (SCLC), run by Amgen at 223 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in China, United States, Japan, Brazil, France and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05740566, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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