Undersøgelse, der sammenligner Tarlatamab og Durvalumab versus Durvalumab alene i førstelinjes omfattende småcellet lungekræft (ES-SCLC) efter platin, etoposid og durvalumab (DeLLphi-305)
5. november 2026 opdateret af: Amgen
En fase 3, open-label, multicenter, randomiseret undersøgelse af Tarlatamab i kombination med Durvalumab vs Durvalumab alene i forsøgspersoner med omfattende småcellet lungekræft efter platin, etoposid og durvalumab
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
563
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
La Rioja, Argentina, F5300COE
- Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
-
Capital Federal, Buenos Aires, Argentina, C1426ANZ
- Instituto Alexander Fleming
-
-
Río Negro Province
-
Cipolletti, Río Negro Province, Argentina, 8324
- Fundacion Medica de Rio Negro y Neuquen
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Exelsus Oncologia Clinica
-
-
-
-
New South Wales
-
Camperdown, New South Wales, Australien, 2050
- Chris OBrien Lifehouse
-
Wollongong, New South Wales, Australien, 2500
- Wollongong Hospital
-
-
Queensland
-
Greenslopes, Queensland, Australien, 4120
- Greenslopes Private Hospital
-
-
South Australia
-
Adelaide, South Australia, Australien, 5000
- Cancer Research South Australia
-
-
Victoria
-
Clayton, Victoria, Australien, 3168
- Monash Medical Centre
-
-
Western Australia
-
Nedlands, Western Australia, Australien, 6009
- Sir Charles Gairdner Hospital
-
-
-
-
-
Aalst, Belgien, 9300
- Azorg Campus Aalst - Moorselbaan
-
Brussels, Belgien, 1090
- Universitair Ziekenhuis Brussel
-
Brussels, Belgien, B-1070
- Institut Jules Bordet
-
Brussels, Belgien, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Edegem, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
-
Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
-
Ghent, Belgien, 9000
- Algemeen Ziekenhuis Maria Middelares
-
Mons, Belgien, 7000
- Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy
-
Yvoir, Belgien, 5530
- Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
-
-
-
-
-
Rio de Janeiro, Brasilien, 22250-905
- Oncoclinicas Rio de Janeiro S A
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brasilien, 40170-110
- Hospital Sao Rafael-Idor
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasilien, 30130-090
- Cenantron Centro Avançado de Tratamento Oncologico Ltda
-
Passos, Minas Gerais, Brasilien, 37904-020
- Santa Casa de Misericordia de Passos
-
-
Paraná
-
Cascavel, Paraná, Brasilien, 85806-300
- Hospital Uopeccan
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, Brasilien, 98700-000
- Hospital de Clinicas de Ijui
-
Passo Fundo, Rio Grande do Sul, Brasilien, 99010-260
- Hospital de Clinicas de Passo Fundo
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90020-090
- Irmandade da Santa Casa de Misericordia de Porto Alegre
-
-
São Paulo
-
São Paulo, São Paulo, Brasilien, 01509-900
- Fundacao Antonio Prudente AC Camargo Cancer Center
-
São Paulo, São Paulo, Brasilien, 05652-900
- Hospital Israelita Albert Einstein
-
-
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
-
-
Quebec
-
Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec Hopital de l Enfant Jesus
-
-
-
-
-
Copenhagen, Danmark, 2100
- Rigshospitalet
-
Herning, Danmark, 7400
- Regionshospitalet Godstrup
-
Odense C, Danmark, 5000
- Odense Universitetshospital
-
-
-
-
Alabama
-
Mobile, Alabama, Forenede Stater, 36607
- Infirmary Cancer Center
-
-
California
-
Los Angeles, California, Forenede Stater, 90033
- University of Southern California
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06510
- Yale New Haven Hospital
-
-
Georgia
-
Athens, Georgia, Forenede Stater, 30607
- University Cancer and Blood Center LLC
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University
-
Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- University of Illinois Chicago
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46237
- Franciscan Health Indianapolis
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70808
- Our Lady of the Lake Cancer Institute
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
-
-
Michigan
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Cancer and Hematology Centers of Western Michigan
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
Saint Paul, Minnesota, Forenede Stater, 55102
- Allina Health System dba Allina Health Cancer Institute
-
-
Missouri
-
Springfield, Missouri, Forenede Stater, 65807
- Oncology Hematology Associates
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68130
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Forenede Stater, 08816
- Astera Cancer Care
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center - Bronx
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- Oncology Hematology Care Incorporated
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Oncology Associates of Oregon, PC
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Medical Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Health Network
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38120
- Baptist Cancer Center Memphis Thoracic
-
Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75246
- Texas Oncology - Dallas Fort Worth
-
Dallas, Texas, Forenede Stater, 75246
- US Oncology Research Investigational Products Center
-
Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
-
-
Virginia
-
Newport News, Virginia, Forenede Stater, 23606
- Virginia Oncology Associates
-
Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- The Medical College of Wisconsin
-
-
-
-
-
Bordeaux, Frankrig, 33000
- Institut Bergonie
-
Brest, Frankrig, 29200
- Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
-
Créteil, Frankrig, 94010
- Centre Hospitalier Intercommunal de Creteil
-
Le Mans, Frankrig, 72000
- Centre Hospitalier - Le Mans
-
Lyon, Frankrig, 69008
- Centre Leon Berard
-
Marseille, Frankrig, 13915
- Centre Hospitalier Universitaire Nord
-
Montpellier, Frankrig, 34298
- Institut regional du Cancer Montpellier
-
Paris, Frankrig, 75014
- Hopital Cochin
-
Saint-Herblain, Frankrig, 44800
- Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
-
Strasbourg, Frankrig, 67091
- Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
-
Toulouse, Frankrig, 31059
- Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
-
Valenciennes, Frankrig, 59300
- Clinique Teissier
-
-
-
-
-
Athens, Grækenland, 18547
- Metropolitan Hospital
-
Athens, Grækenland, 15562
- Metropolitan General
-
Athens, Grækenland, 12462
- Attikon University Hospital
-
Athens, Grækenland, 11526
- Henry Dunant Hospital Center
-
Athens, Grækenland, 11527
- Sotiria General Hospital
-
Thessaloniki, Grækenland, 55236
- Saint Lukes Hospital SA
-
Thessaloniki, Grækenland, 57001
- European Interbalkan Medical Center
-
-
-
-
-
Groningen, Holland, 9713 GZ
- Universitair Medisch Centrum Groningen
-
Maastricht, Holland, 6229 HX
- Maastricht Universitair Medisch Centrum
-
Rotterdam, Holland, 3015 GD
- Erasmus Medisch Centrum
-
-
-
-
-
Kowloon, Hong Kong
- Princess Margaret Hospital
-
Shatin, New Territories, Hong Kong
- Prince of Wales Hospital, Chinese University of Hong Kong
-
-
-
-
-
Dublin, Irland, 9
- Beaumont Hospital
-
-
-
-
-
Haifa, Israel, 3109601
- Rambam Medical Center
-
Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
-
Kfar Saba, Israel, 4428164
- Meir Medical Center
-
Petah Tikva, Israel, 4941492
- Rabin Medical Center
-
-
-
-
-
Bari, Italien, 70124
- IRCCS Istituto Tumori Giovanni Paolo II
-
Milan, Italien, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
-
Milan, Italien, 20141
- IRCCS Istituto Oncologico Europeo
-
Verona, Italien, 37126
- Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center
-
-
Chiba
-
Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
-
Kurume-shi, Fukuoka, Japan, 830-0011
- Kurume University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Hyōgo
-
Akashi-shi, Hyōgo, Japan, 673-8558
- Hyogo Cancer Center
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
-
-
Niigata
-
Niigata, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
-
-
Okayama-ken
-
Okayama, Okayama-ken, Japan, 700-8558
- Okayama University Hospital
-
-
Osaka
-
Hirakata-shi, Osaka, Japan, 573-1191
- Kansai Medical University Hospital
-
Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
-
Osakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital
-
-
Saitama
-
Hidaka-shi, Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
-
-
Shizuoka
-
Sunto-gun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
-
Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
-
Koto-ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
-
-
Wakayama
-
Wakayama, Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
-
-
-
-
-
Beijing, Kina, 100142
- Beijing Cancer Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
-
Beijing, Beijing Municipality, Kina, 100020
- Beijing Chaoyang Hospital, Capital Medical University
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400037
- Xinqiao Hospital
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Fujian Cancer Hospital
-
Quanzhou, Fujian, Kina, 362002
- The Second Attached Hospital Of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Sun Yat-sen University Cancer Center
-
-
Guangxi
-
Guilin, Guangxi, Kina, 541001
- Affiliated Hospital of Guilin Medical University
-
Nanning, Guangxi, Kina, 530201
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Hebei
-
Cangzhou, Hebei, Kina, 061011
- Cangzhou Peoples Hospital
-
-
Heilongjiang
-
Jiamusi, Heilongjiang, Kina, 154007
- Jiamusi Cancer Hospital
-
-
Henan
-
Zhengzhou, Henan, Kina, 450003
- Henan Cancer Hospital
-
Zhengzhou, Henan, Kina, 450066
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan, Hubei, Kina, 430070
- Hubei Cancer Hospital
-
-
Inner Mongolia
-
Hohhot, Inner Mongolia, Kina, 010010
- The Affiliated Hospital of Inner Mongolia Medical University
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Nanjing Chest Hospital
-
Xuzhou, Jiangsu, Kina, 221009
- Xuzhou Central Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330029
- Jiangxi Cancer hospital
-
-
Jilin
-
Changchun, Jilin, Kina, 130012
- Jilin Cancer Hospital
-
-
Shandong
-
Jinan, Shandong, Kina, 250117
- The Affiliated Cancer Hospital of Shandong First Medical University
-
Linyi, Shandong, Kina, 276000
- Linyi Cancer Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200433
- Shanghai Pulmonary Hospital
-
Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
-
-
Shanxi
-
Taiyuan, Shanxi, Kina, 030009
- Shanxi Provincial Cancer Hospital
-
Xi’an, Shanxi, Kina, 710065
- The First Affiliated Hospital of Xian Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 611135
- West China Hospital of Sichuan University
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300121
- Tianjin Peoples Hospital
-
-
Xinjiang
-
Ürümqi, Xinjiang, Kina, 830054
- Affiliated Cancer Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- the First Affiliated Hospital Zhejiang University School of Medicine
-
Ningbo, Zhejiang, Kina, 315010
- The First Affiliated Hospital Of Ningbo University
-
Wenzhou, Zhejiang, Kina, 325015
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 03810
- Oncare
-
Mexico City, Mexico City, Mexico, 03100
- Health Pharma Professional Research SA de CV
-
-
-
-
-
Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Poznan, Polen, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
-
Warsaw, Polen, 01-138
- Instytut Gruzlicy i Chorob Pluc
-
Wroclaw, Polen, 53-439
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
-
-
-
Lisbon, Portugal, 1500-650
- Hospital da Luz, SA
-
Lisbon, Portugal, 1998-018
- Hospital Cuf Descobertas
-
Matosinhos Municipality, Portugal, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
-
Porto, Portugal, 4100-180
- Hospital Cuf porto
-
-
-
-
-
Cluj-Napoca, Rumænien, 400015
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
-
Ploieşti, Rumænien, 100337
- Spitalul Municipal Ploiesti
-
-
-
-
-
Basel, Schweiz, 4052
- Universitaetsspital Basel
-
Bern, Schweiz, 3010
- Inselspital Bern
-
Mendrisio, Schweiz, 6850
- Ospedale Regionale di Bellinzona e Vali
-
Sankt Gallen, Schweiz, 9007
- Kantonsspital Sankt Gallen
-
-
-
-
-
Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
-
-
Andalusia
-
Málaga, Andalusia, Spanien, 29011
- Hospital Regional Universitario de Malaga
-
Seville, Andalusia, Spanien, 41009
- Hospital Universitario Virgen Macarena
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08036
- Hospital Clinic i Provincial de Barcelona
-
Barcelona, Catalonia, Spanien, 08035
- Hospital Universitari Vall d Hebron
-
Barcelona, Catalonia, Spanien, 08041
- Hospital de la Santa Creu i Sant Pau
-
L'Hospitalet de Llobregat, Catalonia, Spanien, 08908
- Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Clinica Universidad de Navarra
-
-
Valencia
-
Valencia, Valencia, Spanien, 46026
- Hospital Universitari i Politecnic La Fe
-
-
-
-
-
Cheongju Chungbuk, Sydkorea, 28644
- Chungbuk National University Hospital
-
Goyang-si Gyeonggi-do, Sydkorea, 10408
- National Cancer Center
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, Sydkorea, 06351
- Samsung Medical Center
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
-
Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
-
-
-
Brno, Tjekkiet, 625 00
- Fakultni nemocnice Brno
-
Olomouc, Tjekkiet, 779 00
- Fakultni nemocnice Olomouc
-
Ostrava-Vitkovice, Tjekkiet, 703 00
- Nemocnice Agel Ostrava-Vitkovice as
-
Prague, Tjekkiet, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Prague, Tjekkiet, 150 06
- Fakultni nemocnice v Motole
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
-
Istanbul, Tyrkiet (Türkiye), 34214
- Bagcilar Medipol Mega Universite Hastanesi
-
Izmir, Tyrkiet (Türkiye), 35150
- Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
-
Mersin, Tyrkiet (Türkiye), 33200
- Medical Park Seyhan Hastanesi
-
Mersin, Tyrkiet (Türkiye), 33200
- VM Medical Park Mersin Hastanesi
-
Sakarya, Tyrkiet (Türkiye), 54290
- Sakarya Egitim ve Arastirma Hastanesi
-
-
-
-
-
Cologne, Tyskland, 51109
- Kliniken der Stadt Koeln gGmbH
-
Dresden, Tyskland, 01307
- Universitaetsklinikum Dresden
-
Essen, Tyskland, 45147
- Universitaetsklinikum Essen
-
Gauting, Tyskland, 82130
- Asklepios Fachkliniken Muenchen Gauting
-
Großhansdorf, Tyskland, 22927
- LungenClinic Grosshansdorf GmbH
-
Heidelberg, Tyskland, 69126
- Universitaetsklinikum Heidelberg
-
Münster, Tyskland, 48149
- University Hospital Muenster
-
Würzburg, Tyskland, 97078
- Universitaetsklinikum Wuerzburg
-
-
-
-
-
Budapest, Ungarn, 1083
- Semmelweis Egyetem
-
Budapest, Ungarn, 1121
- Orszagos Koranyi Pulmonologiai Intezet
-
Gyöngyös, Ungarn, 3200
- Matrai Gyogyintezet
-
Győr, Ungarn, 9024
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
-
Székesfehérvár, Ungarn, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
-
Törökbálint, Ungarn, 2045
- Reformatus Pulmonologiai Centrum
-
-
-
-
-
Graz, Østrig, 8036
- Medizinische Universitaet Graz
-
Krems, Østrig, 3500
- Universitaetsklinikum Krems
-
Rankweil, Østrig, 6830
- Landeskrankenhaus Feldkirch
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion:
- 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.
Exclusion
- 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.
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tarlatamab in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W). |
Intravenous (IV) infusion
Andre navne:
IV infusion |
|
Aktiv komparator: Durvalumab Alone
Participants will receive durvalumab Q4W alone. |
IV infusion |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
OS
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
OS på 2 år
Tidsramme: 2 år
|
2 år
|
|
Progressionsfri overlevelse (PFS)
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Samlet svar (OR)
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Disease Control (DC) Rate
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Varighed af svar (DoR)
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
PFS ved 6 måneder
Tidsramme: 6 måneder
|
6 måneder
|
|
PFS på 1 år
Tidsramme: 1 år
|
1 år
|
|
PFS på 2 år
Tidsramme: 2 år
|
2 år
|
|
OS på 6 måneder
Tidsramme: 6 måneder
|
6 måneder
|
|
OS på 1 år
Tidsramme: 1 år
|
1 år
|
|
OS på 3 år
Tidsramme: 3 år
|
3 år
|
|
Tid til fremskridt (TTP)
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Antal deltagere med behandlingsfremkomne bivirkninger (TEAE'er)
Tidsramme: Op til cirka 9 måneder
|
Op til cirka 9 måneder
|
|
Antal deltagere med TEAE'er Grad 3 eller derover i henhold til Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Antal deltagere med alvorlige TEAE'er
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Antal deltagere med TEAE'er, der fører til seponering af behandling
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Antal deltagere med fatale TEAE'er
Tidsramme: Op til cirka 3 år
|
Op til cirka 3 år
|
|
Antal deltagere med behandlingsrelaterede bivirkninger (AE'er)
Tidsramme: Op til cirka 9 måneder
|
Op til cirka 9 måneder
|
|
Antal deltagere med uønskede hændelser af interesse (EOI)
Tidsramme: Op til cirka 9 måneder
|
Op til cirka 9 måneder
|
|
Serumkoncentrationer af Tarlatamab
Tidsramme: Dag 1 op til cirka 6 måneder
|
Dag 1 op til cirka 6 måneder
|
|
Antal deltagere med antitarlatamab-antistofdannelse
Tidsramme: Op til cirka 9 måneder
|
Op til cirka 9 måneder
|
|
Tid til første forværring (TTD) af fysisk funktion målt med European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
|
Ændring i sygdomsymptomer på hoste målt med EORTC-QLQ LC13
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
|
Ændring i sygdomsymptomer på brystsmerter målt med EORTC-QLQ LC13
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
|
Ændring i sygdomsymptomer på dyspnæ målt med EORTC-QLQ LC13
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
|
TTD for Global Sundhedsstatus som målt af EORTC-QLQ-C30
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
|
TTD for Livskvalitet målt med EORTC-QLQ-C30
Tidsramme: Baseline til uge 13 og uge 25
|
Baseline til uge 13 og uge 25
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. juni 2024
Primær færdiggørelse (Anslået)
2. april 2030
Studieafslutning (Anslået)
2. april 2030
Datoer for studieregistrering
Først indsendt
8. januar 2024
Først indsendt, der opfyldte QC-kriterier
8. januar 2024
Først opslået (Faktiske)
18. januar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20200041
- 2023-505989-29 (Anden identifikator: EU CT Number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD-delingsadgangskriterier
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .