AzTrials
AzTrials

Small-cell Lung CancerPhase 3DeLLphi-312NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

A Phase 3 study testing Tarlatamab, Durvalumab and Carboplatin in people with Small-cell Lung Cancer and Extensive Stage Small-cell Lung Cancer, run by Amgen at 164 sites in 26 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 of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Tarlatamab, Durvalumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
164 sitesin 26 countries
Study dates
18 Aug 2025to 15 Aug 2029
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 before 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 documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV 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.
  • Measurable disease as defined per RECIST 1.1.
  • Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
  • Minimum life expectancy ≥ 12 weeks.

Who cannot join

  • Participants can have no history of other malignancy in the last 2 years.
  • Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
  • They will have no history of severe or life-threatening events to immune-mediated therapy.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  • They will have no active autoimmune or inflammatory disorders.
  • Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
Show all 9Show fewer
  • Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
  • History of solid organ transplant.
  • They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.

Trial locations and contacts

164 sites in 26 countries.

164 sites in 26 countries

United States50 sites

  • New York Oncology Hematology PC

    Albany, New York, 12206

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cancer and Blood Specialists of Arizona

    Casa Grande, Arizona, 85222

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246

  • Cancer Care Specialists of Illinois

    Decatur, Illinois, 62526

  • Hematology Oncology Association of Central New York

    East Syracuse, New York, 13057

  • Minnesota Oncology Hematology PA

    Edina, Minnesota, 55435

  • Willamette Valley Cancer Institute and Research Center - Eugene

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

  • Florida Oncology and Hematology

    Fort Myers, Florida, 33912

  • Providence Saint Jude Medical Center

    Fullerton, California, 92835

  • City of Hope Cancer Center Phoenix

    Goodyear, Arizona, 85338

  • Colorado West Healthcare System dba Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Oncology Consultants

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063

  • Cancer Specialists of North Florida - Southpoint

    Jacksonville, Florida, 32256

  • Saint Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Orlando Health Cancer Institute

    Kissimmee, Florida, 34744

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Los Angeles, California, 90095

  • Central Georgia Cancer Care PC

    Macon, Georgia, 31210

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Allina Health System dba Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

  • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

    New Britain, Connecticut, 06053

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • City of Hope Atlanta

    Newnan, Georgia, 30265

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Kaiser Permanente Medical Center

    Portland, Oregon, 97227

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Midwestern Regional Medical Center dba City of Hope Chicago

    Rockford, Illinois, 61108

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Swedish Cancer Institute Medical Oncology

    Seattle, Washington, 98104

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75701

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • New England Cancer Specialists

    Westbrook, Maine, 04092

  • Presbyterian Intercommunity Hospital Health Whitter Hospital

    Whittier, California, 90602

  • Cancer Center of Kansas, Heritage Plaza Medical Building

    Wichita, Kansas, 67214

Other trials in United States

China17 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100080

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 611135

  • Fujian Cancer Hospital

    Fuzhou, 350011

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jiangxi Cancer hospital

    Nanchang, Jiangxi, 330029

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

  • 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 Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Peoples Hospital

    Tianjin, Tianjin Municipality, 300121

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Japan13 sites

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, 673-8558

  • 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

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • 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

    Sakai-shi, Osaka, 590-0197

  • 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

Other trials in Japan

Germany10 sites

  • Klinikum Chemnitz GmbH

    Chemnitz, 09113

  • Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH

    Cologne, 51109

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82130

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105

  • Universitaetsklinikum Schleswig-Holstein - Luebeck

    Lübeck, 23538

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Spain8 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

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29010

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

France7 sites

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

  • Centre Leon Berard

    Lyon, 69008

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915

  • Institut Curie

    Paris, 75005

  • Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

    Saint-Herblain, 44800

  • Hopital d instruction des armees sainte anne

    Toulon, 83800

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

Other trials in France

Italy6 sites

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC), 47014

  • IRCCS Istituto Oncologico Europeo

    Milan, 20141

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00184

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37126

Other trials in Italy

Turkey (Türkiye)6 sites

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Sakarya Egitim ve Arastirma Hastanesi

    Sakarya, 54290

Other trials in Turkey (Türkiye)

Brazil5 sites

  • Cenantron Centro Avançado de Tratamento Oncologico Ltda

    Belo Horizonte, Minas Gerais, 30130-090

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59062-000

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Fund Faculdade Regional Med Sao Jose Rio Preto

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

  • Centro de Pesquisa do Hospital Albert Einstein

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

Belgium4 sites

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • AZ Delta Campus Rumbeke

    Roeselare, 8800

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

    Yvoir, 5530

Other trials in Belgium

Greece4 sites

  • Henry Dunant Hospital Center

    Athens, 11526

  • Alexandra Hospital

    Athens, 11528

  • European Interbalkan Medical Center

    Thessaloniki, 57001

  • Iatriko Diavalkaniko Thessalonikis

    Thessaloniki, 57001

Other trials in Greece

Argentina3 sites

  • Cemic

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

  • Sanatorio Parque SA

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

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

Poland3 sites

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra, 43-360

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Instytut Gruzlicy i Chorob Pluc

    Warsaw, 01-138

Other trials in Poland

Portugal3 sites

  • Hospital Cuf Tejo

    Lisbon, 1350-352

  • Hospital da Luz, SA

    Lisbon, 1500-650

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

    Matosinhos Municipality, 4464-513

Other trials in Portugal

South Korea3 sites

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

Switzerland3 sites

  • Universitaetsspital Basel

    Basel, 4052

  • Kantonsspital Graubuenden

    Chur, 7000

  • Hopitaux universitaires de Geneve

    Geneva, 1211

Other trials in Switzerland

Australia2 sites

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

Other trials in Australia

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Universitaetsklinikum Krems

    Krems, 3500

Other trials in Austria

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Regionshospitalet Godstrup

    Herning, 7400

Other trials in Denmark

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

Hungary2 sites

  • Matrai Gyogyintezet

    Gyöngyös, 3200

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045

Other trials in Hungary

Israel2 sites

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Mexico1 site

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100

Other trials in Mexico

Romania1 site

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

Other trials in Romania

About this study

Official title: A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Being tested
Tarlatamab, Durvalumab, Carboplatin, Etoposide
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, Imdelltra

    Tarlatamab will be administered as an intravenous (IV) infusion.

  • DurvalumabDrug

    Durvalumab will be administered as an IV infusion.

  • CarboplatinDrug

    Carboplatin will be administered as an IV infusion.

  • EtoposideDrug

    Etoposide will be administered as an IV infusion.

Study groups in NCT07005128
Study groupRoleWhat they receive
Tarlatamab + Durvalumab + Carboplatin + EtoposideExperimentalParticipants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Receives: Drug: Tarlatamab; Drug: Durvalumab; Drug: Carboplatin; Drug: Etoposide
Durvalumab + Carboplatin + EtoposideActive comparatorParticipants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Etoposide

What is being measured

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

  1. Overall Survival (OS)

    Measured: Up to approximately 3.5 years

  2. Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed)

    Measured: Up to approximately 3.5 years

Secondary outcomes (12)

  1. PFS (Investigator Assessed)

    Measured: Up to approximately 4 years

  2. Objective Response (OR)

    Measured: Up to approximately 4 years

  3. Disease Control

    Measured: Up to approximately 4 years

  4. Duration of Response (DOR)

    Measured: Up to approximately 4 years

  5. PFS Rate

    Measured: 6 months, 1 year, and 2 years

  6. OS Rate

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

  7. Time to Progression

    Measured: Up to approximately 4 years

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

    Measured: Up to approximately 4 years

  9. Number of Participants Who Experience Treatment-related Adverse Events

    Measured: Up to approximately 4 years

  10. Number of Participants Who Experience Events of Interest

    Measured: Up to approximately 4 years

  11. Serum Concentrations of Tarlatamab

    Measured: Up to approximately 1 year

  12. Number of Participant Who Develop Anti-Tarlatamab Antibodies

    Measured: Up to 13 months

Timeline

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

  1. First posted5 Jun 2025
  2. Study start18 Aug 2025
  3. Primary completion4 Jan 2029 (estimated)
  4. Study completion15 Aug 2029 (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
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005128
Sponsor's protocol ID
20240178
Acronym
DeLLphi-312
Status last verified
Sep 2026
First submitted
27 May 2025
Last updated
8 Sep 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, Durvalumab and Carboplatin in people with Small-cell Lung Cancer and Extensive Stage Small-cell Lung Cancer, run by Amgen at 164 sites in 26 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 6 inclusion and 9 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, China, Japan, Germany, Spain and 21 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?

Overall Survival (OS) (time frame: Up to approximately 3.5 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 NCT07005128.

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 8 Sep 2026.

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