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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)

Status: Recruiting
Location: See all (148) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Saint Bernards Medical Center
RECRUITING
Jonesboro
Arizona
City of Hope Cancer Center Phoenix
RECRUITING
Goodyear
California
Translational Research in Oncology US Inc, Trio Central Pharmacy
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Santa Monica
Presbyterian Intercommunity Hospital Health Whitter Hospital
RECRUITING
Whittier
Colorado
Colorado West Healthcare System dba Grand Valley Oncology
RECRUITING
Grand Junction
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Florida
Orlando Health Cancer Institute
RECRUITING
Kissimmee
Georgia
City of Hope Atlanta
RECRUITING
Newnan
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Cancer Care Specialists of Illinois
RECRUITING
Decatur
City of Hope Chicago
RECRUITING
Rockford
Indiana
Indiana University Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Kansas
Cancer Center of Kansas, Heritage Plaza Medical Building
RECRUITING
Wichita
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maine
New England Cancer Specialists
RECRUITING
Westbrook
Minnesota
Allina Health System dba Allina Health Cancer Institute
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Nebraska
Cancer Partners of Nebraska
RECRUITING
Lincoln
Nebraska Cancer Specialists
RECRUITING
Omaha
Ohio
Oncology Hematology Care, Inc
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Willamette Valley Cancer Institute and Research Center - Eugene
RECRUITING
Eugene
Kaiser Permanente Medical Center
RECRUITING
Portland
Tennessee
Baptist Cancer Center
RECRUITING
Memphis
United States Oncology Regulatory Affairs Corporate Office
RECRUITING
Nashville
Texas
Texas Oncology
RECRUITING
Dallas
Oncology Consultants
RECRUITING
Houston
US Oncology Research Investigational Products Center
RECRUITING
Irving
Texas Oncology Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists PC
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Swedish Cancer Institute Medical Oncology
RECRUITING
Seattle
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
West Virginia
West Virginia University Health Sciences Center
RECRUITING
Morgantown
Other Locations
Argentina
Cemic
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Universitario Austral
RECRUITING
Pilar
Sanatorio Parque SA
RECRUITING
Rosario
Australia
Chris OBrien Lifehouse
RECRUITING
Camperdown
Monash Medical Centre
RECRUITING
Clayton
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Universitaetsklinikum Krems
RECRUITING
Krems
Belgium
Jessa Ziekenhuis - Campus Virga Jesse
RECRUITING
Hasselt
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
AZ Delta Campus Rumbeke
RECRUITING
Roeselare
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
RECRUITING
Yvoir
Brazil
Cenantron Centro Avançado de Tratamento Oncologico Ltda
RECRUITING
Belo Horizonte
Liga Norte-Riograndense Contra O Cancer
RECRUITING
Natal
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
RECRUITING
Porto Alegre
Fund Faculdade Regional Med Sao Jose Rio Preto
RECRUITING
São José Do Rio Preto
Centro de Pesquisa do Hospital Albert Einstein
RECRUITING
São Paulo
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Cancer Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Jiamusi Cancer Hospital
RECRUITING
Jiamusi
Shandong Cancer Hospital
RECRUITING
Jinan
Jiangxi Cancer hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital Of Ningbo University
RECRUITING
Ningbo
The Second Attached Hospital Of Fujian Medical University
RECRUITING
Quanzhou
Shanghai Chest Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Shanxi Provincial Cancer Hospital
RECRUITING
Taiyuan
Tianjin Cancer Hospital
RECRUITING
Tianjin
Tianjin Peoples Hospital
RECRUITING
Tianjin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Regionshospitalet Godstrup
RECRUITING
Herning
France
Centre Hospitalier Intercommunal de Creteil
RECRUITING
Créteil
Centre Leon Berard
RECRUITING
Lyon
Centre Hospitalier Universitaire Nord
RECRUITING
Marseille
Institut Curie
RECRUITING
Paris
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
RECRUITING
Saint-herblain
Hopital d instruction des armees sainte anne
RECRUITING
Toulon
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
RECRUITING
Toulouse
Germany
Klinikum Chemnitz GmbH
RECRUITING
Chemnitz
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH
RECRUITING
Cologne
Universitaetsklinikum Dresden
RECRUITING
Dresden
Universitaetsklinikum Essen
RECRUITING
Essen
Krankenhaus Nordwest
RECRUITING
Frankfurt Am Main
Asklepios Fachkliniken Muenchen Gauting
RECRUITING
Gauting
LungenClinic Grosshansdorf GmbH
RECRUITING
Großhansdorf
Universitaetsklinikum Schleswig-Holstein - Kiel
RECRUITING
Kiel
Universitaetsklinikum Schleswig-Holstein - Luebeck
RECRUITING
Lübeck
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Alexandra Hospital
RECRUITING
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
European Interbalkan Medical Center
RECRUITING
Thessaloniki
Iatriko Diavalkaniko Thessalonikis
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
RECRUITING
Shatin, New Territories
Hungary
Matrai Gyogyintezet
RECRUITING
Gyöngyös
Reformatus Pulmonologiai Centrum
RECRUITING
Törökbálint
Israel
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center
RECRUITING
Petah Tikva
Italy
IRCCS Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
Humanitas Gavazzeni
RECRUITING
Bergamo
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
RECRUITING
Meldola (fc)
IRCCS Istituto Oncologico Europeo
RECRUITING
Milan
Azienda Ospedaliera San Giovanni Addolorata
RECRUITING
Roma
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
RECRUITING
Verona
Japan
Hyogo Cancer Center
RECRUITING
Akashi-shi
Kyushu University Hospital
RECRUITING
Fukuoka
Saitama Medical University International Medical Center
RECRUITING
Hidaka-shi
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
Kurume University Hospital
RECRUITING
Kurume-shi
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Niigata Cancer Center Hospital
RECRUITING
Niigata
Okayama University Hospital
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Sakai-shi
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Wakayama Medical University Hospital
RECRUITING
Wakayama
Netherlands
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Maastricht Universitair Medisch Centrum
RECRUITING
Maastricht
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
RECRUITING
Bystra
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Instytut Gruzlicy i Chorob Pluc
RECRUITING
Warsaw
Portugal
Hospital Cuf Tejo
RECRUITING
Lisbon
Hospital da Luz, SA
RECRUITING
Lisbon
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju Chungbuk
National Cancer Center
RECRUITING
Goyang-si Gyeonggi-do
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
RECRUITING
Cluj-napoca
Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
Kantonsspital Graubuenden
RECRUITING
Chur
Hopitaux universitaires de Geneve
RECRUITING
Geneva
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Bagcilar Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Sakarya Egitim ve Arastirma Hastanesi
RECRUITING
Sakarya
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2029-07-15
Participants
Target number of participants: 330
Treatments
Experimental: Tarlatamab + Durvalumab + Carboplatin + Etoposide
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Active_comparator: Durvalumab + Carboplatin + Etoposide
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Related Therapeutic Areas
Sponsors
Leads: Amgen
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov

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