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Набира участници Фаза 3 NCT07005128

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Small-cell Lung Cancer Extensive Stage Small-cell Lung Cancer

Спонсор: Amgen

Налично на: БГ
Обобщение
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).
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Интервенции
Tarlatamab
DRUG
Durvalumab
DRUG
Carboplatin
DRUG
Etoposide
DRUG
Места на провеждане 150
Argentina (3)
Cemic
Ciudad Autonoma de Buenos Aires , Buenos Aires
Hospital Universitario Austral
Pilar , Buenos Aires
Sanatorio Parque SA
Rosario , Santa Fe Province
Австралия (2)
Chris OBrien Lifehouse
Camperdown , New South Wales
Monash Medical Centre
Clayton , Victoria
Австрия (2)
Medizinische Universitaet Graz
Graz
Universitaetsklinikum Krems
Krems
Белгия (4)
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
AZ Delta Campus Rumbeke
Roeselare
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir
Бразилия (5)
Cenantron Centro Avançado de Tratamento Oncologico Ltda
Belo Horizonte , Minas Gerais
Liga Norte-Riograndense Contra O Cancer
Natal , Rio Grande do Norte
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre , Rio Grande do Sul
Fund Faculdade Regional Med Sao Jose Rio Preto
São José do Rio Preto , São Paulo
Centro de Pesquisa do Hospital Albert Einstein
São Paulo , São Paulo
Китай (17)
Beijing Cancer Hospital
Beijing , Beijing Municipality
Beijing Cancer Hospital
Beijing
West China Hospital of Sichuan University
Chengdu , Sichuan
Fujian Cancer Hospital
Fuzhou
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Jiamusi Cancer Hospital
Jiamusi , Heilongjiang
Shandong Cancer Hospital
Jinan , Shandong
Jiangxi Cancer hospital
Nanchang , Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
The First Affiliated Hospital Of Ningbo University
Ningbo , Zhejiang
The Second Attached Hospital Of Fujian Medical University
Quanzhou , Fujian
Shanghai Chest Hospital
Shanghai , Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai , Shanghai Municipality
Shanxi Provincial Cancer Hospital
Taiyuan , Shanxi
Tianjin Cancer Hospital
Tianjin , Tianjin Municipality
Tianjin Peoples Hospital
Tianjin , Tianjin Municipality
COMPLETED
Henan Cancer Hospital
Zhengzhou , Henan
Дания (2)
Rigshospitalet
Copenhagen
Regionshospitalet Godstrup
Herning
Франция (7)
Centre Hospitalier Intercommunal de Creteil
Créteil
Centre Leon Berard
Lyon
Centre Hospitalier Universitaire Nord
Marseille
Institut Curie
Paris
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Saint-Herblain
Hopital d instruction des armees sainte anne
Toulon
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse
Германия (10)
Klinikum Chemnitz GmbH
Chemnitz
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH
Cologne
Universitaetsklinikum Dresden
Dresden
Universitaetsklinikum Essen
Essen
Krankenhaus Nordwest
Frankfurt am Main
Asklepios Fachkliniken Muenchen Gauting
Gauting
LungenClinic Grosshansdorf GmbH
Großhansdorf
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel
Universitaetsklinikum Schleswig-Holstein - Luebeck
Lübeck
Universitaetsklinikum Wuerzburg
Würzburg
Гърция (4)
Henry Dunant Hospital Center
Athens
Alexandra Hospital
Athens
European Interbalkan Medical Center
Thessaloniki
Iatriko Diavalkaniko Thessalonikis
Thessaloniki
Hong Kong (2)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories
Унгария (2)
Matrai Gyogyintezet
Gyöngyös
Reformatus Pulmonologiai Centrum
Törökbálint
Израел (2)
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
Италия (6)
IRCCS Istituto Tumori Giovanni Paolo II
Bari
Humanitas Gavazzeni
Bergamo
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC)
IRCCS Istituto Oncologico Europeo
Milan
Azienda Ospedaliera San Giovanni Addolorata
Roma
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona
Япония (13)
Hyogo Cancer Center
Akashi-shi , Hyōgo
Kyushu University Hospital
Fukuoka , Fukuoka
Saitama Medical University International Medical Center
Hidaka-shi , Saitama
Kansai Medical University Hospital
Hirakata-shi , Osaka
Kurume University Hospital
Kurume-shi , Fukuoka
National Hospital Organization Shikoku Cancer Center
Matsuyama , Ehime
Niigata Cancer Center Hospital
Niigata , Niigata
Okayama University Hospital
Okayama , Okayama-ken
Osaka International Cancer Institute
Osaka , Osaka
Kindai University Hospital
Sakai-shi , Osaka
National Hospital Organization Hokkaido Cancer Center
Sapporo , Hokkaido
Shizuoka Cancer Center
Sunto-gun , Shizuoka
Wakayama Medical University Hospital
Wakayama , Wakayama
Нидерландия (3)
Universitair Medisch Centrum Groningen
Groningen
Maastricht Universitair Medisch Centrum
Maastricht
Erasmus Medisch Centrum
Rotterdam
Полша (3)
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra
Uniwersyteckie Centrum Kliniczne
Gdansk
Instytut Gruzlicy i Chorob Pluc
Warsaw
Португалия (3)
Hospital Cuf Tejo
Lisbon
Hospital da Luz, SA
Lisbon
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality
Румъния (1)
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca
Южна Корея (3)
Chungbuk National University Hospital
Cheongju Chungbuk
National Cancer Center
Goyang-si Gyeonggi-do
Severance Hospital Yonsei University Health System
Seoul
Испания (8)
Hospital Universitari Vall d Hebron
Barcelona , Catalonia
Hospital Clinic i Provincial de Barcelona
Barcelona , Catalonia
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalonia
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
Hospital Regional Universitario de Malaga
Málaga , Andalusia
Hospital Universitari i Politecnic La Fe
Valencia , Valencia
Швейцария (3)
Universitaetsspital Basel
Basel
Kantonsspital Graubuenden
Chur
Hopitaux universitaires de Geneve
Geneva
Taiwan (2)
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
Турция (6)
Memorial Ankara Hastanesi
Ankara
Ankara Bilkent Sehir Hastanesi
Ankara
Bagcilar Medipol Mega Universite Hastanesi
Istanbul
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
Izmir
Sakarya Egitim ve Arastirma Hastanesi
Sakarya
САЩ (37)
Dana Farber Cancer Institute
Boston , Massachusetts
University of Illinois Chicago
Chicago , Illinois
Oncology Hematology Care, Inc
Cincinnati , Ohio
University Hospitals Cleveland Medical Center
Cleveland , Ohio
Texas Oncology
Dallas , Texas
Cancer Care Specialists of Illinois
Decatur , Illinois
Minnesota Oncology Hematology PA
Edina , Minnesota
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene , Oregon
Virginia Cancer Specialists PC
Fairfax , Virginia
City of Hope Cancer Center Phoenix
Goodyear , Arizona
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction , Colorado
Oncology Consultants
Houston , Texas
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis , Indiana
US Oncology Research Investigational Products Center
Irving , Texas
Saint Bernards Medical Center
Jonesboro , Arkansas
Orlando Health Cancer Institute
Kissimmee , Florida
Cancer Partners of Nebraska
Lincoln , Nebraska
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles , California
Baptist Cancer Center
Memphis , Tennessee
Allina Health System dba Allina Health Cancer Institute
Minneapolis , Minnesota
West Virginia University Health Sciences Center
Morgantown , West Virginia
United States Oncology Regulatory Affairs Corporate Office
Nashville , Tennessee
Yale New Haven Hospital
New Haven , Connecticut
City of Hope Atlanta
Newnan , Georgia
Virginia Oncology Associates
Norfolk , Virginia
Nebraska Cancer Specialists
Omaha , Nebraska
Kaiser Permanente Medical Center
Portland , Oregon
Mayo Clinic
Rochester , Minnesota
City of Hope Chicago
Rockford , Illinois
University of California Los Angeles
Santa Monica , California
Swedish Cancer Institute Medical Oncology
Seattle , Washington
New York Cancer and Blood Specialists
Shirley , New York
Northwest Medical Specialties, PLLC
Tacoma , Washington
Texas Oncology Northeast Texas
Tyler , Texas
New England Cancer Specialists
Westbrook , Maine
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier , California
Cancer Center of Kansas, Heritage Plaza Medical Building
Wichita , Kansas
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
18.08.2025
Крайна дата
15.07.2029
Регистрационен номер
NCT07005128
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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