AzTrials
AzTrials

Extensive-Stage Small-Cell Lung CancerPhase 3DeLLphi-305NCT06211036

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

A Phase 3 study testing Tarlatamab and Durvalumab in people with Extensive-Stage Small-Cell Lung Cancer and Small-Cell Lung Cancer, run by Amgen at 219 sites in 29 countries.

Active, not recruiting

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

Official record
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Trial summary

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Tarlatamab and Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
563 participants
Where
219 sitesin 29 countries
Study dates
5 Jun 2024to 2 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 to 99 years
  • 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 the country if it is older than 18 years).
  • Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  • Minimum life expectancy > 12 weeks.
  • Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
  • Adequate organ function.
  • Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is > 6 months since the end of previous therapy and progression, in discussion with the medical monitor.

Who cannot join

  • Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
  • Prior history of severe or life-threatening events from any immune-mediated therapy.
  • History of other malignancy within the past 2 years, with some exceptions as per protocol.
  • Active or prior documented autoimmune or inflammatory disorders as per protocol.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
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  • Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
  • History of solid organ transplant.
  • Major surgical procedures within 28 days of first dose of study treatment.
  • Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
  • History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
  • Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
  • Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
  • Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  • Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
  • Treatment in an alternative investigational trial within 28 days prior to enrollment.
  • Has received or is planning to receive consolidative chest radiation for extensive stage disease.
  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
  • Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
  • Female participants planning to become pregnant or donate eggs while on study as per protocol.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
  • Male participants unwilling to abstain from donating sperm during treatment as per protocol.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. Participants who are unable to complete clinical outcome assessments are eligible.

Trial locations and contacts

219 sites in 29 countries.

219 sites in 29 countries

United States37 sites

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • Emory University

    Atlanta, Georgia, 30322

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • Oncology Hematology Care Incorporated

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246

  • US Oncology Research Investigational Products Center

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Oncology Associates of Oregon, PC

    Eugene, Oregon, 97401

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • University of Southern California

    Los Angeles, California, 90033

  • Baptist Cancer Center Memphis Thoracic

    Memphis, Tennessee, 38120

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Infirmary Cancer Center

    Mobile, Alabama, 36607

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Allina Health System dba Allina Health Cancer Institute

    Saint Paul, Minnesota, 55102

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

  • Montefiore Medical Center - Bronx

    The Bronx, New York, 10461

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

China31 sites

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer Hospital

    Beijing, 100142

  • Cangzhou Peoples Hospital

    Cangzhou, Hebei, 061011

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 611135

  • Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400037

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

  • the First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010010

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

  • Jiangxi Cancer hospital

    Nanchang, Jiangxi, 330029

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530201

  • The First Affiliated Hospital Of Ningbo University

    Ningbo, Zhejiang, 315010

  • The Second Attached Hospital Of Fujian Medical University

    Quanzhou, Fujian, 362002

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030009

  • Tianjin Peoples Hospital

    Tianjin, Tianjin Municipality, 300121

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430070

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710065

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450066

Other trials in China

Japan19 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

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • 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

  • 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

  • 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

France12 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan

    Brest, 29200

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

  • Centre Hospitalier - Le Mans

    Le Mans, 72000

  • Centre Leon Berard

    Lyon, 69008

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915

  • Institut regional du Cancer Montpellier

    Montpellier, 34298

  • Hopital Cochin

    Paris, 75014

  • Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

  • Clinique Teissier

    Valenciennes, 59300

Other trials in France

Brazil10 sites

  • Cenantron Centro Avançado de Tratamento Oncologico Ltda

    Belo Horizonte, Minas Gerais, 30130-090

  • Hospital Uopeccan

    Cascavel, Paraná, 85806-300

  • Hospital de Clinicas de Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital de Clinicas de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Santa Casa de Misericordia de Passos

    Passos, Minas Gerais, 37904-020

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905

  • Hospital Sao Rafael-Idor

    Salvador, Estado de Bahia, 40170-110

  • Fundacao Antonio Prudente AC Camargo Cancer Center

    São Paulo, São Paulo, 01509-900

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

Belgium9 sites

  • Azorg Campus Aalst - Moorselbaan

    Aalst, 9300

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Institut Jules Bordet

    Brussels, B-1070

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, 9000

  • Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy

    Mons, 7000

  • Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

    Yvoir, 5530

Other trials in Belgium

Spain9 sites

  • 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

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

Germany8 sites

  • Kliniken der Stadt Koeln gGmbH

    Cologne, 51109

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82130

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69126

  • University Hospital Muenster

    Münster, 48149

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Greece7 sites

  • Henry Dunant Hospital Center

    Athens, 11526

  • Sotiria General Hospital

    Athens, 11527

  • Attikon University Hospital

    Athens, 12462

  • Metropolitan General

    Athens, 15562

  • Metropolitan Hospital

    Athens, 18547

  • Saint Lukes Hospital SA

    Thessaloniki, 55236

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

South Korea7 sites

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia6 sites

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, 1121

  • Matrai Gyogyintezet

    Gyöngyös, 3200

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

    Győr, 9024

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045

Other trials in Hungary

Turkey (Türkiye)6 sites

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi

    Izmir, 35150

  • Medical Park Seyhan Hastanesi

    Mersin, 33200

  • VM Medical Park Mersin Hastanesi

    Mersin, 33200

  • Sakarya Egitim ve Arastirma Hastanesi

    Sakarya, 54290

Other trials in Turkey (Türkiye)

Argentina5 sites

  • Hospital Britanico de Buenos Aires

    CABA, Buenos Aires, C1280AEB

  • Instituto Alexander Fleming

    Capital Federal, Buenos Aires, C1426ANZ

  • Fundacion Medica de Rio Negro y Neuquen

    Cipolletti, Río Negro Province, 8324

  • Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE

  • Exelsus Oncologia Clinica

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Nemocnice Agel Ostrava-Vitkovice as

    Ostrava-Vitkovice, 703 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Italy4 sites

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • IRCCS Istituto Oncologico Europeo

    Milan, 20141

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37126

Other trials in Italy

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

    Poznan, 60-569

  • Instytut Gruzlicy i Chorob Pluc

    Warsaw, 01-138

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-439

Other trials in Poland

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

Switzerland4 sites

  • Universitaetsspital Basel

    Basel, 4052

  • Inselspital Bern

    Bern, 3010

  • Ospedale Regionale di Bellinzona e Vali

    Mendrisio, 6850

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Austria3 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Universitaetsklinikum Krems

    Krems, 3500

  • Landeskrankenhaus Feldkirch

    Rankweil, 6830

Other trials in Austria

Denmark3 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Regionshospitalet Godstrup

    Herning, 7400

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Netherlands3 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1R 2J6

Other trials in Canada

Hong Kong2 sites

  • Princess Margaret Hospital

    Kowloon

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

Mexico2 sites

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100

  • Oncare

    Mexico City, Mexico City, 03810

Other trials in Mexico

Romania2 sites

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

Other trials in Romania

Ireland1 site

  • Beaumont Hospital

    Dublin, 9

Other trials in Ireland

About this study

Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Being tested
Tarlatamab, Durvalumab
Keywords
Extensive-Stage Small-Cell Lung Cancer, ES-SCLC, Platinum, Etoposide, Durvalumab, Tarlatamab, AMG 757
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

  • DurvalumabDrug

    IV infusion

Study groups in NCT06211036
Study groupRoleWhat they receive
Tarlatamab in Combination With DurvalumabExperimentalParticipants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Receives: Drug: Tarlatamab; Drug: Durvalumab
Durvalumab AloneActive comparatorParticipants will receive durvalumab Q4W alone.
Receives: Drug: Durvalumab

What is being measured

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

  1. OS

    Measured: Up to approximately 3 years

Secondary outcomes (27)

  1. Progression Free Survival (PFS)

    Measured: Up to approximately 3 years

  2. Overall Response (OR)

    Measured: Up to approximately 3 years

  3. Disease Control (DC) Rate

    Measured: Up to approximately 3 years

  4. Duration of Response (DoR)

    Measured: Up to approximately 3 years

  5. PFS at 6 Months

    Measured: 6 months

  6. PFS at 1 Year

    Measured: 1 year

  7. PFS at 2 Years

    Measured: 2 years

  8. OS at 6 Months

    Measured: 6 months

  9. OS at 1 Year

    Measured: 1 year

  10. OS at 2 Years

    Measured: 2 years

  11. OS at 3 Years

    Measured: 3 years

  12. Time to Progression (TTP)

    Measured: Up to approximately 3 years

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

    Measured: Up to approximately 9 months

  14. Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to approximately 3 years

  15. Number of Participants with Serious TEAEs

    Measured: Up to approximately 3 years

  16. Number of Participants with TEAEs Leading to Discontinuation of Treatment

    Measured: Up to approximately 3 years

  17. Number of Participants with Fatal TEAEs

    Measured: Up to approximately 3 years

  18. Number of Participants with Treatment-related Adverse Events (AEs)

    Measured: Up to approximately 9 months

  19. Number of Participants with Adverse Events of Interest (EOI)

    Measured: Up to approximately 9 months

  20. Serum Concentrations of Tarlatamab

    Measured: Day 1 up to approximately 6 months

  21. Number of Participants with Antitarlatamab Antibody Formation

    Measured: Up to approximately 9 months

  22. Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)

    Measured: Baseline to Week 13 and Week 25

  23. Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13

    Measured: Baseline to Week 13 and Week 25

  24. Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13

    Measured: Baseline to Week 13 and Week 25

  25. Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13

    Measured: Baseline to Week 13 and Week 25

  26. TTD for Global Health Status as Measured by EORTC-QLQ-C30

    Measured: Baseline to Week 13 and Week 25

  27. TTD for Quality of Life as Measured by EORTC-QLQ-C30

    Measured: Baseline to Week 13 and Week 25

Timeline

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

  1. First posted18 Jan 2024
  2. Study start5 Jun 2024
  3. Primary completion2 Apr 2030 (estimated)
  4. Study completion2 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
None (open label)
Enrolment
563 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211036
Sponsor's protocol ID
20200041
Other IDs
2023-505989-29, 2023
Acronym
DeLLphi-305
Status last verified
Nov 2026
First submitted
8 Jan 2024
Last updated
6 Nov 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.

Publications

  • Perol M, Yoshida T, Ahn MJ, Gay CM, Schuler M, Liu H, Sezer A, Bilici A, Korantzis I, Lim SM, Otsubo K, Juan-Vidal O, Chen Y, Schvartsman G, Wang H, Dingemans AC, Clarke JM, Desai A, Marigil M, Chen Y, Abidi B, Wang J, Sands J; DeLLphi-305 Investigators. Tarlatamab-Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2026 Oct 24. doi: 10.1056/NEJMoa2609482. Online ahead of print.

    PubMed 42929702

  • Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.

    PubMed 40934933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarlatamab and Durvalumab in people with Extensive-Stage Small-Cell Lung Cancer and Small-Cell Lung Cancer, run by Amgen at 219 sites in 29 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 30 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, China, Japan, France, Brazil and 24 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?

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?

OS (time frame: Up to approximately 3 years). 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 NCT06211036, which also lists 2 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 6 Nov 2026.

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