AzTrials
AzTrials

Limited Stage Small Cell Lung CancerPhase 3DeLLphi-306NCT06117774

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

A Phase 3 study testing Tarlatamab in people with Limited Stage Small Cell Lung Cancer and Small Cell Lung Cancer, run by Amgen at 204 sites in 27 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 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
204 sitesin 27 countries
Study dates
20 Feb 2024to 20 Apr 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

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.

Trial locations and contacts

204 sites in 27 countries.

204 sites in 27 countries

China23 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

  • Jiangxi Cancer hospital

    Nanchang, Jiangxi, 330029

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315016

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030009

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Zhejiang Taizhou Hospital

    Taizhou, Zhejiang, 317099

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

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

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430070

  • Northern Jiangsu Peoples hospital

    Yangzhou, Jiangsu, 225009

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Japan20 sites

  • 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

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806

  • 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

  • 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

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi, 321-0293

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States18 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Spokenword Clinical Trials

    Easton, Pennsylvania, 18045

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • University of Louisville James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • 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

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374

  • Boca Raton Clinical Research Global South Florida

    Plantation, Florida, 33322

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • US Oncology Research Investigational Products Center

    The Woodlands, Texas, 77380

Other trials in United States

Brazil15 sites

  • Fundacao pio xII Barretos

    Barretos, São Paulo, 14784-400

  • Centro Catarinense de Pesquisa LTDA

    Blumenau, Santa Catarina, 89015-200

  • Oncoclinicas Onco Vida Distrito Federal

    Brasília, Federal District, 70200-730

  • Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner

    Curitba, Paraná, 81520-060

  • Fundacao Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Londrina Cancer Hospital

    Londrina, Paraná, 86015-520

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Cipo - Centro Integrado de Pesquisa em Oncologia

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Dor de Pesquisa e Ensino

    Rio de Janeiro, 22793-080

  • Centro de pesquisa em oncologia Hospital Ana Nery

    Santa Cruz do Sul, Rio Grande do Sul, 96835-090

  • Cepho

    Santo André, São Paulo, 09060-650

  • Instituto Cancer Sao Paulo Icesp

    São Paulo, 01246-000

  • Hospital Santa Rita

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

Spain15 sites

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Canary Islands, 35016

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Instituto Valenciano de Oncologia

    Valencia, Valencia, 46009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

Turkey (Türkiye)12 sites

  • Ankara Etlik Sehir Hastanesi

    Ankara, 06200

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Marmara Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34890

  • Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35110

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli, 41380

  • Medical Park Seyhan Hastanesi

    Mersin, 33200

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55200

Other trials in Turkey (Türkiye)

Italy10 sites

  • Centro di Riferimento Oncologico di Aviano

    Aviano PN, 33081

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IRCCS Istituto Oncologico Europeo

    Milan, 20141

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06156

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • IRCCS Istituto Clinico Humanitas

    Rozzano MI, 20089

  • Ospedale San Giuseppe Moscati

    Statte, 74010

Other trials in Italy

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Gyeongsang National University Hospital

    Jinju, 52727

  • Cha Bundang Medical Center, Cha University

    Seongnam-si, Gyeonggi-do, 13496

  • 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

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

Argentina8 sites

  • Instituto Argentino de Diagnóstico y Tratamiento

    Buenos Aires, C1122AAL

  • Hospital Aleman Buenos Aires

    CABA, Distrito Federal, C1118AAT

  • Fundacion Respirar

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP

  • Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo

    Córdoba, Córdoba Province, 5003

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

  • Sanatorio 9 de Julio Cice 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Greece8 sites

  • Agios Savvas Anticancer Hospital

    Athens, 11522

  • Henry Dunant Hospital Center

    Athens, 11526

  • Sotiria General Hospital

    Athens, 11527

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

    Athens, 12462

  • Metropolitan General

    Athens, 15562

  • Metropolitan Hospital

    Athens, 18547

  • Saint Luke Hospital

    Thessaloniki, 55236

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-540

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra, 43-360

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-090

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

    Poznan, 60-569

  • Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia

    Prabuty, 82-550

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemyśl, 37-700

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Bulgaria7 sites

  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD

    Panagyurishte, 4500

  • Complex Oncology Center Plovdiv EOOD

    Plovdiv, 4004

  • Complex Oncology Center Shumen EOOD

    Shumen, 9700

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD

    Sofia, 1113

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment Serdikamed EOOD

    Sofia, 1632

Other trials in Bulgaria

Romania7 sites

  • Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu

    Balotesti, Ilfov, 077015

  • Institutul Oncologic, Prof Dr Alexandru Trestioreanu

    Bucharest, 022328

  • 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

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Australia5 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Colombia5 sites

  • Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic

    Bogota, Cundinamarca, 0129

  • Instituto Nacional de Cancerologia

    Bogota, Cundinamarca, 111711

  • Fundacion cardiovascular de Colombia

    Bucaramanga, Santander Department, 681017

  • Instituto Medico de Alta Tecnologia sas - Imat sas

    Montería, Departamento de Córdoba

  • Oncologos del Occidente SAS

    Pereira, Risaralda Department, 660001

Other trials in Colombia

France5 sites

  • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

    Lille, 59037

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, 06002

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Hopital Nord Ouest Villefranche sur Saone

    Villefranche-sur-Saône, 69400

Other trials in France

Mexico4 sites

  • Centro Oncologico Personalizado

    Cuauhtémoc, Mexico City, 06760

  • Oncare

    Mexico City, Mexico City, 03810

  • Oncocenter Clinica Integral Internacional de Oncologia

    Puebla City, 72530

  • Phylasis Clinicas Research Toluca

    Toluca, 50090

Other trials in Mexico

Germany3 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsmedizin Goettingen

    Göttingen, 37075

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Portugal3 sites

  • Unidade Local de Saude de Braga, EPE

    Braga, 4710-243

  • Hospital da Luz, SA

    Lisbon, 1500-650

  • Hospital Cuf porto

    Porto, 4100-180

Other trials in Portugal

Switzerland3 sites

  • Kantonsspital Baden

    Baden, 5404

  • Universitaetsspital Basel

    Basel, 4052

  • Ospedale Regionale di Bellinzona e Vali

    Mendrisio, 6850

Other trials in Switzerland

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Institut Jules Bordet

    Brussels, B-1070

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Hong Kong2 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

Singapore2 sites

  • National Cancer Centre Singapore

    Singapore, 168583

  • Icon - Mount Alvernia

    Singapore, 217562

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Norrlands Universitetssjukhus

    Umeå, 901 85

Other trials in Sweden

United Kingdom2 sites

  • Guys Hospital

    London, SE1 9RT

  • Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: 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).

Being tested
Tarlatamab, Placebo
Keywords
Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer, LS SCLC, 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

    Intravenous (IV) infusion

  • PlaceboDrug

    IV infusion

Study groups in NCT06117774
Study groupRoleWhat they receive
TarlatamabExperimentalParticipants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Receives: Drug: Tarlatamab
PlaceboPlacebo comparatorParticipants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
Receives: Drug: Placebo

What is being measured

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

  1. PFS as Determined by BICR

    Measured: Up to approximately 6 years

  2. OS Over the Whole Trial

    Measured: Up to approximately 6 years

Secondary outcomes (10)

  1. PFS Determined by Investigator Assessment

    Measured: Up to approximately 6 years

  2. Complete Response (CR) Rate

    Measured: Up to approximately 6 years

  3. CR + non-CR/non-Progressive Disease (PD) Rate

    Measured: Up to approximately 6 years

  4. Duration of Complete Response

    Measured: Up to approximately 6 years

  5. PFS at 6 months, 1 year, 2 years

    Measured: 6 months, 1 year, 2 years

  6. OS at 6 months, 1 year, 2 years, 3 years

    Measured: 6 months, 1 year, 2 years, 3 years

  7. Time to Progression (TTP)

    Measured: Up to approximately 6 years

  8. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 6 years

  9. Serum Concentration of Tarlatamab

    Measured: Up to approximately 4 months

  10. Incidence of Anti-tarlatamab Antibody Formation

    Measured: Up to approximately 1 year

Timeline

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

  1. First posted7 Nov 2023
  2. Study start20 Feb 2024
  3. Primary completion20 Apr 2030 (estimated)
  4. Study completion20 Apr 2030 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06117774
Sponsor's protocol ID
20230016
Other IDs
2023-506235-15, 2023
Acronym
DeLLphi-306
Status last verified
Apr 2026
First submitted
31 Oct 2023
Last updated
29 Apr 2026
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarlatamab in people with Limited Stage Small Cell Lung Cancer and Small Cell Lung Cancer, run by Amgen at 204 sites in 27 countries.

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

Who may be eligible to take part?

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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in China, Japan, United States, Brazil, Spain and 22 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

PFS as Determined by BICR (time frame: Up to approximately 6 years). The study lists 2 primary outcomes in all. 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 NCT06117774.

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 29 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in