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Clinical Trial NCT07005128 (DeLLphi-312) for Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AmgenA Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) (DeLLphi-312) Phase 3 330 Overall Survival
Clinical Trial NCT07005128 (DeLLphi-312) is designed to study Treatment for Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. It is a Phase 3 interventional study that is recruiting, having started on August 18, 2025, with plans to enroll 330 participants. Led by Amgen, it is expected to complete by July 15, 2029. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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).
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)
Conditions
Small-cell Lung CancerExtensive Stage Small-cell Lung CancerOther Study IDs
- DeLLphi-312
- 20240178
NCT ID Number
Start Date (Actual)
2025-08-18
Last Update Posted
2026-03-30
Completion Date (Estimated)
2029-07-15
Enrollment (Estimated)
330
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTarlatamab + Durvalumab + Carboplatin + Etoposide Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab. | Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Durvalumab Durvalumab will be administered as an IV infusion. Carboplatin Carboplatin will be administered as an IV infusion. Etoposide Etoposide will be administered as an IV infusion. |
Active ComparatorDurvalumab + Carboplatin + Etoposide Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab. | Durvalumab Durvalumab will be administered as an IV infusion. Carboplatin Carboplatin will be administered as an IV infusion. Etoposide Etoposide will be administered as an IV infusion. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival (OS) | Up to approximately 3.5 years | |
Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) | Up to approximately 3.5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PFS (Investigator Assessed) | Up to approximately 4 years | |
Objective Response (OR) | Up to approximately 4 years | |
Disease Control | Up to approximately 4 years | |
Duration of Response (DOR) | Up to approximately 4 years | |
PFS Rate | 6 months, 1 year, and 2 years | |
OS Rate | 6 months, 1 year, 2 years and 3 years | |
Time to Progression | Up to approximately 4 years | |
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) | Up to approximately 4 years | |
Number of Participants Who Experience Treatment-related Adverse Events | Up to approximately 4 years | |
Number of Participants Who Experience Events of Interest | Up to approximately 4 years | |
Serum Concentrations of Tarlatamab | Up to approximately 1 year | |
Number of Participant Who Develop Anti-Tarlatamab Antibodies | Up to 13 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
- 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.
AstraZeneca772 active studies to exploreStudy Central Contact
Contact: Amgen Call Center, 866-572-6436, [email protected]
140 Study Locations in 25 Countries
Arkansas
Saint Bernards Medical Center, Jonesboro, Arkansas, 72401, United States
Recruiting
California
Translational Research in Oncology US Inc, Trio Central Pharmacy, Los Angeles, California, 90095, United States
Recruiting
University of California Los Angeles, Santa Monica, California, 90404, United States
Recruiting
Presbyterian Intercommunity Hospital Health Whitter Hospital, Whittier, California, 90602, United States
Recruiting
Colorado
Colorado West Healthcare System dba Grand Valley Oncology, Grand Junction, Colorado, 81505, United States
Recruiting
Connecticut
Yale New Haven Hospital, New Haven, Connecticut, 06510, United States
Recruiting
Florida
Orlando Health Cancer Institute, Kissimmee, Florida, 34744, United States
Recruiting
Illinois
University of Illinois Chicago, Chicago, Illinois, 60612, United States
Recruiting
Cancer Care Specialists of Illinois, Decatur, Illinois, 62526, United States
Recruiting
Indiana
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States
Recruiting
Kansas
Cancer Center of Kansas, Heritage Plaza Medical Building, Wichita, Kansas, 67214, United States
Recruiting
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Recruiting
Minnesota
Allina Health System dba Allina Health Cancer Institute, Minneapolis, Minnesota, 55407, United States
Recruiting
Mayo Clinic, Rochester, Minnesota, 55905, United States
Recruiting
Nebraska
Cancer Partners of Nebraska, Lincoln, Nebraska, 68516, United States
Recruiting
Nebraska Cancer Specialists, Omaha, Nebraska, 68130, United States
Recruiting
Ohio
Oncology Hematology Care, Inc, Cincinnati, Ohio, 45242, United States
Recruiting
University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States
Recruiting
Oregon
Willamette Valley Cancer Institute and Research Center - Eugene, Eugene, Oregon, 97401, United States
Recruiting
Kaiser Permanente Medical Center, Portland, Oregon, 97227, United States
Recruiting
Tennessee
Baptist Cancer Center, Memphis, Tennessee, 38120, United States
Recruiting
United States Oncology Regulatory Affairs Corporate Office, Nashville, Tennessee, 37203, United States
Recruiting
Texas
US Oncology Research Investigational Products Center, Irving, Texas, 75063, United States
Recruiting
Texas Oncology Northeast Texas, Tyler, Texas, 75702, United States
Recruiting
Virginia
Virginia Cancer Specialists PC, Fairfax, Virginia, 22031, United States
Recruiting
Washington
Swedish Cancer Institute Medical Oncology, Seattle, Washington, 98104, United States
Recruiting
West Virginia
West Virginia University Health Sciences Center, Morgantown, West Virginia, 26506, United States
Recruiting
Buenos Aires
Cemic, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Recruiting
Hospital Universitario Austral, Pilar, Buenos Aires, B1629ODT, Argentina
Recruiting
Santa Fe Province
Sanatorio Parque SA, Rosario, Santa Fe Province, 2000, Argentina
Recruiting
New South Wales
Chris OBrien Lifehouse, Camperdown, New South Wales, 2050, Australia
Recruiting
Victoria
Monash Medical Centre, Clayton, Victoria, 3168, Australia
Recruiting
Medizinische Universitaet Graz, Graz, 8036, Austria
Recruiting
Universitaetsklinikum Krems, Krems, 3500, Austria
Recruiting
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, 3500, Belgium
Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, 3000, Belgium
Recruiting
AZ Delta Campus Rumbeke, Roeselare, 8800, Belgium
Recruiting
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne, Yvoir, 5530, Belgium
Recruiting
Minas Gerais
Cenantron Centro Avançado de Tratamento Oncologico Ltda, Belo Horizonte, Minas Gerais, 30130-090, Brazil
Recruiting
Rio Grande do Norte
Liga Norte-Riograndense Contra O Cancer, Natal, Rio Grande do Norte, 59062-000, Brazil
Recruiting
Rio Grande do Sul
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Recruiting
São Paulo
Fund Faculdade Regional Med Sao Jose Rio Preto, São José do Rio Preto, São Paulo, 15090-000, Brazil
Recruiting
Centro de Pesquisa do Hospital Albert Einstein, São Paulo, São Paulo, 05652-900, Brazil
Recruiting
Beijing Municipality
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100080, China
Recruiting
Fujian
The Second Attached Hospital Of Fujian Medical University, Quanzhou, Fujian, 362002, China
Recruiting
Heilongjiang
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150000, China
Recruiting
Jiamusi Cancer Hospital, Jiamusi, Heilongjiang, 154007, China
Recruiting
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450003, China
Recruiting
Jiangxi
Jiangxi Cancer hospital, Nanchang, Jiangxi, 330029, China
Recruiting
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330209, China
Recruiting
Shandong
Shandong Cancer Hospital, Jinan, Shandong, 250117, China
Recruiting
Shanghai Municipality
Shanghai Chest Hospital, Shanghai, Shanghai Municipality, 200030, China
Recruiting
Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, 200433, China
Recruiting
Shanxi
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, 030009, China
Recruiting
Sichuan
West China Hospital of Sichuan University, Chengdu, Sichuan, 611135, China
Recruiting
Tianjin Municipality
Tianjin Cancer Hospital, Tianjin, Tianjin Municipality, 300060, China
Recruiting
Tianjin Peoples Hospital, Tianjin, Tianjin Municipality, 300121, China
Recruiting
Zhejiang
The First Affiliated Hospital Of Ningbo University, Ningbo, Zhejiang, 315010, China
Recruiting
Beijing Cancer Hospital, Beijing, 100142, China
Recruiting
Fujian Cancer Hospital, Fuzhou, 350011, China
Recruiting
Rigshospitalet, Copenhagen, 2100, Denmark
Recruiting
Regionshospitalet Godstrup, Herning, 7400, Denmark
Recruiting
Centre Hospitalier Intercommunal de Creteil, Créteil, 94010, France
Recruiting
Centre Leon Berard, Lyon, 69008, France
Recruiting
Centre Hospitalier Universitaire Nord, Marseille, 13915, France
Recruiting
Institut Curie, Paris, 75005, France
Recruiting
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec, Saint-Herblain, 44800, France
Recruiting
Hopital d instruction des armees sainte anne, Toulon, 83800, France
Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey, Toulouse, 31059, France
Recruiting
Klinikum Chemnitz GmbH, Chemnitz, 09113, Germany
Recruiting
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH, Cologne, 51109, Germany
Recruiting
Universitaetsklinikum Dresden, Dresden, 01307, Germany
Recruiting
Universitaetsklinikum Essen, Essen, 45147, Germany
Recruiting
Krankenhaus Nordwest, Frankfurt am Main, 60488, Germany
Recruiting
Asklepios Fachkliniken Muenchen Gauting, Gauting, 82130, Germany
Recruiting
LungenClinic Grosshansdorf GmbH, Großhansdorf, 22927, Germany
Recruiting
Universitaetsklinikum Schleswig-Holstein - Kiel, Kiel, 24105, Germany
Recruiting
Universitaetsklinikum Schleswig-Holstein - Luebeck, Lübeck, 23538, Germany
Recruiting
Universitaetsklinikum Wuerzburg, Würzburg, 97078, Germany
Recruiting
Henry Dunant Hospital Center, Athens, 11526, Greece
Recruiting
Alexandra Hospital, Athens, 11528, Greece
Recruiting
European Interbalkan Medical Center, Thessaloniki, 57001, Greece
Recruiting
Iatriko Diavalkaniko Thessalonikis, Thessaloniki, 57001, Greece
Recruiting
Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong
Recruiting
Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Recruiting
Matrai Gyogyintezet, Gyöngyös, 3200, Hungary
Recruiting
Reformatus Pulmonologiai Centrum, Törökbálint, 2045, Hungary
Recruiting
Meir Medical Center, Kfar Saba, 4428164, Israel
Recruiting
Rabin Medical Center, Petah Tikva, 4941492, Israel
Recruiting
IRCCS Istituto Tumori Giovanni Paolo II, Bari, 70124, Italy
Recruiting
Humanitas Gavazzeni, Bergamo, 24125, Italy
Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola (FC), 47014, Italy
Recruiting
IRCCS Istituto Oncologico Europeo, Milan, 20141, Italy
Recruiting
Azienda Ospedaliera San Giovanni Addolorata, Roma, 00184, Italy
Recruiting
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata, Verona, 37126, Italy
Recruiting
Ehime
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0280, Japan
Recruiting
Fukuoka
Kyushu University Hospital, Fukuoka, Fukuoka, 812-8582, Japan
Recruiting
Kurume University Hospital, Kurume-shi, Fukuoka, 830-0011, Japan
Recruiting
Hokkaido
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 003-0804, Japan
Recruiting
Hyōgo
Hyogo Cancer Center, Akashi-shi, Hyōgo, 673-8558, Japan
Recruiting
Niigata
Niigata Cancer Center Hospital, Niigata, Niigata, 951-8566, Japan
Recruiting
Okayama-ken
Okayama University Hospital, Okayama, Okayama-ken, 700-8558, Japan
Recruiting
Osaka
Kansai Medical University Hospital, Hirakata-shi, Osaka, 573-1191, Japan
Recruiting
Osaka International Cancer Institute, Osaka, Osaka, 541-8567, Japan
Recruiting
Kindai University Hospital, Sakai-shi, Osaka, 590-0197, Japan
Recruiting
Saitama
Saitama Medical University International Medical Center, Hidaka-shi, Saitama, 350-1298, Japan
Recruiting
Shizuoka
Shizuoka Cancer Center, Sunto-gun, Shizuoka, 411-8777, Japan
Recruiting
Wakayama
Wakayama Medical University Hospital, Wakayama, Wakayama, 641-8510, Japan
Recruiting
Universitair Medisch Centrum Groningen, Groningen, 9713 GZ, Netherlands
Recruiting
Maastricht Universitair Medisch Centrum, Maastricht, 6229 HX, Netherlands
Recruiting
Erasmus Medisch Centrum, Rotterdam, 3015 GD, Netherlands
Recruiting
Centrum Pulmonologii i Torakochirurgii w Bystrej, Bystra, 43-360, Poland
Recruiting
Uniwersyteckie Centrum Kliniczne, Gdansk, 80-214, Poland
Recruiting
Instytut Gruzlicy i Chorob Pluc, Warsaw, 01-138, Poland
Recruiting
Hospital Cuf Tejo, Lisbon, 1350-352, Portugal
Recruiting
Hospital da Luz, SA, Lisbon, 1500-650, Portugal
Recruiting
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos Municipality, 4464-513, Portugal
Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj-Napoca, 400015, Romania
Recruiting
Chungbuk National University Hospital, Cheongju Chungbuk, 28644, South Korea
Recruiting
National Cancer Center, Goyang-si Gyeonggi-do, 10408, South Korea
Recruiting
Severance Hospital Yonsei University Health System, Seoul, 03722, South Korea
Recruiting
Andalusia
Hospital Regional Universitario de Malaga, Málaga, Andalusia, 29010, Spain
Recruiting
Catalonia
Hospital Universitari Vall d Hebron, Barcelona, Catalonia, 08035, Spain
Recruiting
Hospital Clinic i Provincial de Barcelona, Barcelona, Catalonia, 08036, Spain
Recruiting
Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, 08041, Spain
Recruiting
Madrid
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, 28222, Spain
Recruiting
Valencia
Hospital Universitari i Politecnic La Fe, Valencia, Valencia, 46026, Spain
Recruiting
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Recruiting
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Recruiting
Universitaetsspital Basel, Basel, 4052, Switzerland
Recruiting
Kantonsspital Graubuenden, Chur, 7000, Switzerland
Recruiting
Hopitaux universitaires de Geneve, Geneva, 1211, Switzerland
Recruiting
National Cheng Kung University Hospital, Tainan, 70403, Taiwan
Recruiting
Taipei Veterans General Hospital, Taipei, 11217, Taiwan
Recruiting
Memorial Ankara Hastanesi, Ankara, 06520, Turkey (Türkiye)
Recruiting
Ankara Bilkent Sehir Hastanesi, Ankara, 06800, Turkey (Türkiye)
Recruiting
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, 34214, Turkey (Türkiye)
Recruiting
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, 34722, Turkey (Türkiye)
Recruiting
Ege Universitesi Tip Fakultesi Hastanesi, Izmir, 35100, Turkey (Türkiye)
Recruiting
Sakarya Egitim ve Arastirma Hastanesi, Sakarya, 54290, Turkey (Türkiye)
Recruiting