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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarlatamab + Durvalumab + Carboplatin + Etoposide | Experimental | Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab. |
|
| Durvalumab + Carboplatin + Etoposide | Active Comparator | Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | Tarlatamab will be administered as an intravenous (IV) infusion. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Investigator Assessed) | Up to approximately 4 years | |
| Objective Response (OR) | Up to approximately 4 years | |
| Disease Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Blood Specialists of Arizona | Recruiting | Casa Grande | Arizona | 85222 | United States | |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| Durvalumab | Drug | Durvalumab will be administered as an IV infusion. |
|
| Carboplatin | Drug | Carboplatin will be administered as an IV infusion. |
|
| Etoposide | Drug | Etoposide will be administered as an IV infusion. |
|
| 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 |
| City of Hope Cancer Center Phoenix |
| Recruiting |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| Genesis Cancer Center | Recruiting | Hot Springs | Arkansas | 71913 | United States |
| Saint Bernards Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
| Providence Saint Jude Medical Center | Recruiting | Fullerton | California | 92835 | United States |
| Translational Research in Oncology US Inc, Trio Central Pharmacy | Recruiting | Los Angeles | California | 90095 | United States |
| University of California Los Angeles | Recruiting | Santa Monica | California | 90404 | United States |
| Presbyterian Intercommunity Hospital Health Whitter Hospital | Recruiting | Whittier | California | 90602 | United States |
| Colorado West Healthcare System dba Grand Valley Oncology | Recruiting | Grand Junction | Colorado | 81505 | United States |
| Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut | Recruiting | New Britain | Connecticut | 06053 | United States |
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Recruiting | Norwich | Connecticut | 06360 | United States |
| Florida Oncology and Hematology | Recruiting | Fort Myers | Florida | 33912 | United States |
| Cancer Specialists of North Florida - Southpoint | Recruiting | Jacksonville | Florida | 32256 | United States |
| Orlando Health Cancer Institute | Recruiting | Kissimmee | Florida | 34744 | United States |
| Central Georgia Cancer Care PC | Recruiting | Macon | Georgia | 31210 | United States |
| City of Hope Atlanta | Recruiting | Newnan | Georgia | 30265 | United States |
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Cancer Care Specialists of Illinois | Recruiting | Decatur | Illinois | 62526 | United States |
| Midwestern Regional Medical Center dba City of Hope Chicago | Recruiting | Rockford | Illinois | 61108 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Hematology Oncology of Indiana | Recruiting | Indianapolis | Indiana | 46260 | United States |
| Cancer Center of Kansas, Heritage Plaza Medical Building | Recruiting | Wichita | Kansas | 67214 | United States |
| New England Cancer Specialists | Recruiting | Westbrook | Maine | 04092 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Minnesota Oncology Hematology PA | Recruiting | Edina | Minnesota | 55435 | United States |
| Allina Health System dba Allina Health Cancer Institute | Recruiting | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Hattiesburg Clinic Hematology/Oncology | Recruiting | Hattiesburg | Mississippi | 39401 | United States |
| Cancer Partners of Nebraska | Recruiting | Lincoln | Nebraska | 68516 | United States |
| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
| New York Oncology Hematology PC | Recruiting | Albany | New York | 12206 | United States |
| Hematology Oncology Association of Central New York | Recruiting | East Syracuse | New York | 13057 | United States |
| New York Cancer and Blood Specialists | Recruiting | Shirley | New York | 11967 | United States |
| Oncology Hematology Care, Inc | Recruiting | Cincinnati | Ohio | 45242 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| Willamette Valley Cancer Institute and Research Center - Eugene | Recruiting | Eugene | Oregon | 97401 | United States |
| Kaiser Permanente Medical Center | Recruiting | Portland | Oregon | 97227 | United States |
| Baptist Cancer Center | Recruiting | Memphis | Tennessee | 38120 | United States |
| United States Oncology Regulatory Affairs Corporate Office | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Dallas Fort Worth | Recruiting | Dallas | Texas | 75246 | United States |
| Oncology Consultants | Recruiting | Houston | Texas | 77030 | United States |
| US Oncology Research Investigational Products Center | Recruiting | Irving | Texas | 75063 | United States |
| University of Texas Health Science Center at Tyler | Recruiting | Tyler | Texas | 75701 | United States |
| Texas Oncology Northeast Texas | Recruiting | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists PC | Recruiting | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
| Swedish Cancer Institute Medical Oncology | Recruiting | Seattle | Washington | 98104 | United States |
| Northwest Medical Specialties, PLLC | Recruiting | Tacoma | Washington | 98405 | United States |
| West Virginia University Health Sciences Center | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Cemic | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1431FWO | Argentina |
| Hospital Universitario Austral | Recruiting | Pilar | Buenos Aires | B1629ODT | Argentina |
| Sanatorio Parque SA | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| Chris OBrien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
| Medizinische Universitaet Graz | Recruiting | Graz | 8036 | Austria |
| Universitaetsklinikum Krems | Recruiting | Krems | 3500 | Austria |
| Jessa Ziekenhuis - Campus Virga Jesse | Terminated | Hasselt | 3500 | Belgium |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
| AZ Delta Campus Rumbeke | Recruiting | Roeselare | 8800 | Belgium |
| Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne | Recruiting | Yvoir | 5530 | Belgium |
| Cenantron Centro Avançado de Tratamento Oncologico Ltda | Recruiting | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Liga Norte-Riograndense Contra O Cancer | Recruiting | Natal | Rio Grande do Norte | 59062-000 | Brazil |
| Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Fund Faculdade Regional Med Sao Jose Rio Preto | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Centro de Pesquisa do Hospital Albert Einstein | Recruiting | São Paulo | São Paulo | 05652-900 | Brazil |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100080 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| The Second Attached Hospital Of Fujian Medical University | Recruiting | Quanzhou | Fujian | 362002 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
| Jiamusi Cancer Hospital | Recruiting | Jiamusi | Heilongjiang | 154007 | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
| Jiangxi Cancer hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330209 | China |
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030009 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 611135 | China |
| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| Tianjin Peoples Hospital | Terminated | Tianjin | Tianjin Municipality | 300121 | China |
| The First Affiliated Hospital Of Ningbo University | Recruiting | Ningbo | Zhejiang | 315010 | China |
| Fujian Cancer Hospital | Recruiting | Fuzhou | 350011 | China |
| Rigshospitalet | Completed | Copenhagen | 2100 | Denmark |
| Regionshospitalet Godstrup | Completed | Herning | 7400 | Denmark |
| Centre Hospitalier Intercommunal de Creteil | Terminated | Créteil | 94010 | France |
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
| Centre Hospitalier Universitaire Nord | Recruiting | Marseille | 13915 | France |
| Institut Curie | Recruiting | Paris | 75005 | France |
| Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec | Recruiting | Saint-Herblain | 44800 | France |
| Hopital d instruction des armees sainte anne | Recruiting | Toulon | 83800 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Recruiting | Toulouse | 31059 | France |
| Klinikum Chemnitz GmbH | Recruiting | Chemnitz | 09113 | Germany |
| Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH | Recruiting | Cologne | 51109 | Germany |
| Universitaetsklinikum Dresden | Recruiting | Dresden | 01307 | Germany |
| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Krankenhaus Nordwest | Recruiting | Frankfurt am Main | 60488 | Germany |
| Asklepios Fachkliniken Muenchen Gauting | Recruiting | Gauting | 82130 | Germany |
| LungenClinic Grosshansdorf GmbH | Recruiting | Großhansdorf | 22927 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Kiel | Recruiting | Kiel | 24105 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Luebeck | Recruiting | Lübeck | 23538 | Germany |
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | 97078 | Germany |
| Henry Dunant Hospital Center | Recruiting | Athens | 11526 | Greece |
| Alexandra Hospital | Recruiting | Athens | 11528 | Greece |
| European Interbalkan Medical Center | Recruiting | Thessaloniki | 57001 | Greece |
| Iatriko Diavalkaniko Thessalonikis | Recruiting | Thessaloniki | 57001 | Greece |
| Queen Mary Hospital, The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| Prince of Wales Hospital, Chinese University of Hong Kong | Terminated | Shatin, New Territories | Hong Kong |
| Matrai Gyogyintezet | Recruiting | Gyöngyös | 3200 | Hungary |
| Reformatus Pulmonologiai Centrum | Terminated | Törökbálint | 2045 | Hungary |
| Meir Medical Center | Recruiting | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
| IRCCS Istituto Tumori Giovanni Paolo II | Recruiting | Bari | 70124 | Italy |
| Humanitas Gavazzeni | Terminated | Bergamo | 24125 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori Dino Amadori | Terminated | Meldola (FC) | 47014 | Italy |
| IRCCS Istituto Oncologico Europeo | Recruiting | Milan | 20141 | Italy |
| Azienda Ospedaliera San Giovanni Addolorata | Recruiting | Roma | 00184 | Italy |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata | Recruiting | Verona | 37126 | Italy |
| National Hospital Organization Shikoku Cancer Center | Recruiting | Matsuyama | Ehime | 791-0280 | Japan |
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
| Kurume University Hospital | Recruiting | Kurume-shi | Fukuoka | 830-0011 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Recruiting | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo Cancer Center | Recruiting | Akashi-shi | Hyōgo | 673-8558 | Japan |
| Niigata Cancer Center Hospital | Recruiting | Niigata | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Recruiting | Okayama | Okayama-ken | 700-8558 | Japan |
| Kansai Medical University Hospital | Recruiting | Hirakata-shi | Osaka | 573-1191 | Japan |
| Osaka International Cancer Institute | Recruiting | Osaka | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Recruiting | Sakai-shi | Osaka | 590-0197 | Japan |
| Saitama Medical University International Medical Center | Recruiting | Hidaka-shi | Saitama | 350-1298 | Japan |
| Shizuoka Cancer Center | Recruiting | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Wakayama Medical University Hospital | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
| Health Pharma Professional Research SA de CV | Recruiting | Mexico City | Mexico City | 03100 | Mexico |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| Maastricht Universitair Medisch Centrum | Recruiting | Maastricht | 6229 HX | Netherlands |
| Erasmus Medisch Centrum | Recruiting | Rotterdam | 3015 GD | Netherlands |
| Centrum Pulmonologii i Torakochirurgii w Bystrej | Recruiting | Bystra | 43-360 | Poland |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| Instytut Gruzlicy i Chorob Pluc | Recruiting | Warsaw | 01-138 | Poland |
| Hospital Cuf Tejo | Recruiting | Lisbon | 1350-352 | Portugal |
| Hospital da Luz, SA | Recruiting | Lisbon | 1500-650 | Portugal |
| Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano | Recruiting | Matosinhos Municipality | 4464-513 | Portugal |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca | Terminated | Cluj-Napoca | 400015 | Romania |
| Chungbuk National University Hospital | Recruiting | Cheongju Chungbuk | 28644 | South Korea |
| National Cancer Center | Recruiting | Goyang-si Gyeonggi-do | 10408 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | Andalusia | 29010 | Spain |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Recruiting | Barcelona | Catalonia | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Catalonia | 08041 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Universitaetsspital Basel | Recruiting | Basel | 4052 | Switzerland |
| Kantonsspital Graubuenden | Recruiting | Chur | 7000 | Switzerland |
| Hopitaux universitaires de Geneve | Recruiting | Geneva | 1211 | Switzerland |
| National Cheng Kung University Hospital | Recruiting | Tainan | 70403 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| Memorial Ankara Hastanesi | Recruiting | Ankara | 06520 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Bagcilar Medipol Mega Universite Hastanesi | Recruiting | Istanbul | 34214 | Turkey (Türkiye) |
| Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi | Recruiting | Istanbul | 34722 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Hastanesi | Recruiting | Izmir | 35100 | Turkey (Türkiye) |
| Sakarya Egitim ve Arastirma Hastanesi | Recruiting | Sakarya | 54290 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722655 | AMG 757 |
| C000613593 | durvalumab |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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