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Brief Title: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Official Title: A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Study ID: NCT05740566
Brief Summary: The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Alaska Oncology and Hematology, Anchorage, Alaska, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California Los Angeles, Santa Monica, California, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Indiana U Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
Pikeville Medical Center, Pikeville, Kentucky, United States
Our Lady of the Lake Cancer Institute, Baton Rouge, Louisiana, United States
Trinity Health Saint Joseph Mercy Ann Arbor, Ann Arbor, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
University of Missouri Health Care, Columbia, Missouri, United States
Summit Medical Group, Overlook Oncology Center, Summit, New Jersey, United States
New York University Langone Health, New York, New York, United States
Perlmutter Cancer Center at New York University Langone Hospital----Long Island, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Northport Veterans Affairs Medical Center, Northport, New York, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Sanford Oncology Clinic and Pharmacy, Sioux Falls, South Dakota, United States
University of Tennessee Medical Center Knoxville, Knoxville, Tennessee, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Swedish Cancer Institute Medical Oncology, Edmonds, Washington, United States
The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cemic, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral, Pilar, Buenos Aires, Argentina
Clinica Viedma, Viedma, Río Negro, Argentina
Sanatorio Parque SA, Rosario, Santa Fe, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT, Buenos Aires, , Argentina
Sanatorio Allende, Córdoba, , Argentina
Liverpool Hospital, Liverpool, New South Wales, Australia
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
Monash Medical Centre, Clayton, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Medizinische Universitaet Graz, Graz, , Austria
Universitaetsklinikum Krems, Krems, , Austria
Universitair Ziekenhuis Gent, Gent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, , Belgium
AZ Delta Campus Rumbeke, Roeselare, , Belgium
Vitaz campus Sint-Niklaas Moerland, Sint-Niklaas, , Belgium
Hospital Santa Izabel, Salvador, Bahia, Brazil
Instituto de Ensino e Pesquisa do Hospital da Bahia, Salvador, Bahia, Brazil
Liga Norte-Riograndense Contra O Cancer, Natal, Rio Grande Do Norte, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor da Amazonia, Porto Velho, Rondônia, Brazil
Beneficencia Portuguesa de Sao Paulo, Sao Paulo, São Paulo, Brazil
Oncologia Rede D Or, Sao Paulo, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto, São Paulo, Brazil
Instituto Coi, Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp, São Paulo, , Brazil
London Health Sciences Centre, London, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Anhui Chest Hospital, Hefei, Anhui, China
Beijing Tongren Hospital affiliated to Capital Medical University, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
The Second Affiliated Hospital of Army Medical University, PLA, Chongqing, Chongqing, China
Army Special Medical Center of Peoples Liberation Army, Chongqing, Chongqing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Jiangmen Central Hospital, Jiangmen, Guangdong, China
The 4th Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Subei Peoples Hospital, Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jinan Central Hospital, Jinan, Shandong, China
Shandong Tumor Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanxi Province Cancer Hospital, Taiyuan, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Beijing Chest Hospital, Capital Medical University, Beijing, , China
Fujian Cancer Hospital, Fuzhou, , China
Tianjin Peoples Hospital, Tianjin, , China
Weihai Municipal Hospital, Weihai, , China
Fakultni nemocnice Brno, Brno, , Czechia
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Nemocnice Agel Ostrava-Vitkovice as, Ostrava-Vitkovice, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Rigshospitalet, Copenhagen, , Denmark
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon, Grenoble, , France
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon, Lille Cedex, , France
Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren, Limoges Cedex, , France
Centre Leon Berard, Lyon, , France
Centre Hospitalier Universitaire Nord, Marseille Cedex 20, , France
Institut Curie, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Benite cedex, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou, Rennes Cedex 9, , France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil, Strasbourg Cedex, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey, Toulouse Cedex 9, , France
Gustave Roussy, Villejuif, , France
Charite Universitaetsmedizin Berlin, Campus Virchow, Berlin, , Germany
Universitaetsklinikum Dresden, Dresden, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Asklepios Fachkliniken Muenchen Gauting, Gauting, , Germany
LungenClinic Grosshansdorf GmbH, Grosshansdorf, , Germany
Universitaetsklinikum Koeln, Koeln, , Germany
Robert-Bosch-Krankenhaus, Stuttgart, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Saint Savas Hospital, Athens, , Greece
Henry Dunant Hospital Center, Athens, , Greece
Thoracic General Hospital Of Athens Sotiria, Athens, , Greece
Alexandra Hospital, Athens, , Greece
University Hospital of Heraklion, Heraklion - Crete, , Greece
Olympion Therapeftirio General Clinic Of Patras, Patra, , Greece
Saint Luke Hospital, Thessaloniki, , Greece
European Interbalkan Medical Center, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet, Budapest, , Hungary
Matrai Gyogyintezet, Gyongyos, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabanya, , Hungary
Reformatus Pulmonologiai Centrum, Torokbalint, , Hungary
Beaumont Hospital, Dublin, , Ireland
Rambam Medical Center, Haifa, , Israel
Hadassah Ein-Kerem Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Humanitas Gavazzeni, Bergamo, , Italy
Azienda Ospedaliera Universitaria Renato Dulbecco, Catanzaro, , Italy
Ospedale Policlinico San Martino IRCCS, Genova, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola (FC), , Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliera San Giovanni Addolorata, Roma, , Italy
National Hospital Organization Nagoya Medical Center, Nagoya-shi, Aichi, Japan
Aichi Cancer Center, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
Kurume University Hospital, Kurume-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Hyogo Cancer Center, Akashi-shi, Hyogo, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
Sendai Kousei Hospital, Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center, Hidaka-Shi, Saitama, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital, Wakayama-shi, Wakayama, Japan
Chungbuk National University Hospital, Cheongju Chungbuk, , Korea, Republic of
National Cancer Center, Goyang-si Gyeonggi-do, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Gyeongsang National University Hospital, Jinju-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia
Sarawak General Hospital, Kuching, Sarawak, Malaysia
University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia
Oncare, Ciudad de México, Distrito Federal, Mexico
Health Pharma Professional Research SA de CV, Mexico City, Distrito Federal, Mexico
coi Centro Oncologico Internacional sapi de cv, Tlajomulco de Zúñiga, Jalisco, Mexico
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Centrum Pulmonologii i Torakochirurgii w Bystrej, Bystra, , Poland
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo, Krakow, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow, Poznan, , Poland
Hospital da Luz, SA, Lisboa, , Portugal
Hospital Cuf Descobertas, Lisboa, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos, , Portugal
Hospital Cuf porto, Porto, , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj Napoca, , Romania
Centrul de Oncologie Sf Nectarie SRL, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
SC Oncomed SRL, Timisoara, , Romania
National Cancer Centre Singapore, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, Aragón, Spain
Hospital del Mar, Barcelona, Cataluña, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera, A Coruña, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Kantonsspital Graubuenden, Chur, , Switzerland
Freiburg Spital, Fribourg, , Switzerland
Hopitaux universitaires de Geneve, Geneve 14, , Switzerland
Kantonsspital Sankt Gallen, Sankt Gallen, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Veterans General Hospital - Taichung, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Memorial Ankara Hastanesi, Ankara, , Turkey
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi, Denizli, , Turkey
Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi, Izmir, , Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir, , Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya, , Turkey
University College London Hospital, London, , United Kingdom
Guys Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR