A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
June 3, 2026 updated by: Amgen
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
750
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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Buenos Aires, Argentina, 1426
- Recruiting
- Centro Oncologico Korben
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La Rioja, Argentina, F5300COE
- Completed
- Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
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Salta, Argentina, 4400
- Recruiting
- Centro de Diagnostico Investigacion y Tratamiento
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1280AEB
- Completed
- Hospital Britanico de Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1426ANZ
- Recruiting
- Instituto Alexander Fleming
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
- Recruiting
- Instituto Argentino de Diagnostico y Tratamiento IADT
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La Plata, Buenos Aires, Argentina, B1900AUR
- Recruiting
- Hospital Italiano de La Plata
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Jujuy Province
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San Salvador de Jujuy, Jujuy Province, Argentina, 4600
- Recruiting
- Fundación Ars Medica
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Río Negro Province
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Viedma, Río Negro Province, Argentina, 8500
- Recruiting
- Clinica Viedma
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- Sanatorio Parque SA
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- Fundacion Estudios Clinicos
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Recruiting
- Campbelltown Hospital
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Concord, New South Wales, Australia, 2139
- Recruiting
- Concord Repatriation General Hospital
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Kingswood, New South Wales, Australia, 2747
- Recruiting
- Nepean Cancer Centre
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Port Macquarie, New South Wales, Australia, 2444
- Recruiting
- Port Macquarie Base Hospital
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St Leonards, New South Wales, Australia, 2065
- Completed
- GenesisCare -North Shore Oncology
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Waratah, New South Wales, Australia, 2298
- Recruiting
- Calvary Mater Newcastle Hospital
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Queensland
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Toowoomba, Queensland, Australia, 4350
- Recruiting
- Toowoomba Hospital
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Recruiting
- Cancer Research South Australia
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Victoria
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Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter MacCallum Cancer Centre
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Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
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-
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Graz, Austria, 8036
- Recruiting
- Medizinische Universitaet Graz
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Klagenfurt, Austria, 9020
- Recruiting
- Klinikum Klagenfurt am Woerthersee
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Krems, Austria, 3500
- Recruiting
- Universitaetsklinikum Krems
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Salzburg, Austria, 5020
- Completed
- Landeskrankenhaus Salzburg
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Wels, Austria, 4600
- Recruiting
- Klinikum Wels - Grieskirchen GmbH
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Auderghem, Belgium, 1160
- Completed
- Chirec - Delta Ziekenhuis
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Ghent, Belgium, 9000
- Recruiting
- Algemeen Ziekenhuis Maria Middelares
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Leuven, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Liège, Belgium, 4000
- Recruiting
- Centre Hospitalier Régional de la Citadelle
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Mechelen, Belgium, 2800
- Completed
- Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
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-
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-
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Rio de Janeiro, Brazil, 22250-905
- Recruiting
- Oncoclinicas Rio de Janeiro S A
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São Paulo, Brazil, 01246-000
- Recruiting
- Instituto Cancer Sao Paulo Icesp
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São Paulo, Brazil, 01236-030
- Terminated
- Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-014
- Recruiting
- Hospital Evangelico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 40170-110
- Recruiting
- Nucleo de Oncologia da Bahia
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-
Federal District
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Brasília, Federal District, Brazil, 70200-730
- Recruiting
- Hospital Sirio Libanes Brasilia
-
Brasília, Federal District, Brazil, 70390-150
- Recruiting
- Oncoclinicas Onco Vida Distrito Federal
-
-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30380-472
- Recruiting
- Nucleo de Ensino Pesquisa e Inovacao Mario Penna
-
-
Pará
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Belém, Pará, Brazil, 66073-005
- Recruiting
- Centro de Tratamento Oncologico - Cto
-
-
Pernambuco
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Recife, Pernambuco, Brazil, 50070-550
- Recruiting
- Instituto Medicina Integral Imip
-
-
Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil, 59062-000
- Recruiting
- Liga Norte-Riograndense Contra O Cancer
-
-
Rio Grande do Sul
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Canoas, Rio Grande do Sul, Brazil, 92030-000
- Terminated
- Associação Beneficente de Canoas
-
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Recruiting
- Irmandade Da Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Recruiting
- Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
-
Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96835-090
- Recruiting
- Centro de pesquisa em oncologia Hospital Ana Nery
-
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Santa Catarina
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Itajaí, Santa Catarina, Brazil, 88301-220
- Terminated
- Clínica de Neoplasias Litoral
-
-
São Paulo
-
Barretos, São Paulo, Brazil, 14784-400
- Recruiting
- Fundacao pio xII Barretos
-
Santos, São Paulo, Brazil, 11075-900
- Recruiting
- Santa Casa de Misericordia de Santos - Iscms
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- Hospital de Base de Sao Jose do Rio Preto
-
São Paulo, São Paulo, Brazil, 01509-900
- Recruiting
- Fundacao Antonio Prudente
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São Paulo, São Paulo, Brazil, 01323-030
- Recruiting
- Beneficencia Portuguesa de Sao Paulo - Bp
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-
-
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Panagyurishte, Bulgaria, 4500
- Recruiting
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD
-
Pleven, Bulgaria, 5800
- Terminated
- University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD
-
Sofia, Bulgaria, 1330
- Recruiting
- Multiprofile Hospital for Active Treatment for Womens Health - Nadezhda OOD
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Sofia, Bulgaria, 1527
- Terminated
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Recruiting
- Queen Elizabeth II, Health Sciences Centre
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Research Institute Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Recruiting
- McGill University Health Centre Glen Site
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Montreal, Quebec, Canada, H4J 1C5
- Recruiting
- CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal
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Québec, Quebec, Canada, G1V 4G5
- Recruiting
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Recruiting
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Recruiting
- Saskatoon Cancer Centre
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-
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Santiago, Chile, 7500713
- Terminated
- Orlandi Oncologia
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Santiago, Chile, 7500836
- Recruiting
- Fundacion Arturo Lopez Perez
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Santiago, Chile, 8330336
- Recruiting
- Biocinetic servicios medicos limitada
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Talca, Chile, 346000
- Terminated
- Centro de Investigación del Maule
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Cautín
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Temuco, Cautín, Chile, 4800827
- Terminated
- James Lind Centro de Investigacion del Cancer
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Temuco, Cautín, Chile, 4810218
- Terminated
- Clinica CIDO
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Beijing, China, 100142
- Recruiting
- Beijing Cancer hospital
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Beijing, China, 101149
- Recruiting
- Beijing Chest Hospital, Capital Medical University
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Anhui
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Bengbu, Anhui, China, 233004
- Recruiting
- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, China, 230022
- Recruiting
- Anhui Chest Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Recruiting
- Peking Union Medical College Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400030
- Recruiting
- Chongqing University Cancer Hospital
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Fujian
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Fuzhou, Fujian, China, 350014
- Recruiting
- Fujian Cancer Hospital
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Fuzhou, Fujian, China, 350001
- Recruiting
- Fujian Provincial Hospital
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Fuzhou, Fujian, China, 350109
- Recruiting
- Fujian Medical University Union Hospital
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Xiamen, Fujian, China, 361004
- Recruiting
- Zhongshan Hospital Xiamen University
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Xiamen, Fujian, China, 361003
- Recruiting
- The First Affiliated Hospital of Xiamen University
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Gansu
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Lanzhou, Gansu, China, 730050
- Recruiting
- Gansu Province Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510095
- Recruiting
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
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Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong Provincial Peoples Hospital
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Shantou, Guangdong, China, 515031
- Recruiting
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Liuzhou, Guangxi, China, 545006
- Recruiting
- Liuzhou Peoples Hospital
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Nanning, Guangxi, China, 530021
- Recruiting
- Guangxi Medical University Cancer Hospital
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Hainan
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Haikou, Hainan, China, 570311
- Recruiting
- Hainan Cancer Hospital
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Hebei
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Baoding, Hebei, China, 071000
- Recruiting
- Affiliated Hospital of Hebei University
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recruiting
- Harbin Medical University Cancer Hospital
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Henan
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Anyang, Henan, China, 455001
- Recruiting
- Anyang Tumor Hospital
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Luoyang, Henan, China, 471003
- Recruiting
- The First Affiliated Hospital of Henan University of Science and Technology
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Zhengzhou, Henan, China, 450000
- Recruiting
- Henan Cancer Hospital
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Zhengzhou, Henan, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430022
- Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital Tongji Medical College of HUST
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Xiangyang, Hubei, China, 441021
- Recruiting
- Xiangyang Central Hospital
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-
Hunan
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Changsha, Hunan, China, 410013
- Recruiting
- Hunan Cancer Hospital
-
Changsha, Hunan, China, 410000
- Recruiting
- Xiangya Hospital Central South University
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Changsha, Hunan, China, 410011
- Recruiting
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, China, 410031
- Recruiting
- Hunan Cancer Hospital
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-
Jiangsu
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Nanjing, Jiangsu, China, 210008
- Recruiting
- Nanjing Drum Tower Hospital
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Nanjing, Jiangsu, China, 210012
- Recruiting
- Nanjing First Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- Recruiting
- The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, China, 330029
- Recruiting
- Jiangxi Cancer Hospital
-
-
Jilin
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Changchun, Jilin, China, 130012
- Recruiting
- Jilin Cancer Hospital
-
-
Shandong
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Jinan, Shandong, China, 250117
- Recruiting
- Cancer Hospital of Shandong First Medical University
-
Linyi, Shandong, China, 276002
- Recruiting
- Linyi Peoples Hospital
-
Weifang, Shandong, China, 261071
- Recruiting
- Weifang Peoples Hospital
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
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-
Shanxi
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Taiyuan, Shanxi, China, 030013
- Recruiting
- Shanxi Cancer Hospital
-
Xi’an, Shanxi, China, 710065
- Recruiting
- The First Affiliated Hospital of Xi An JiaoTong University
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-
Sichuan
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Chengdu, Sichuan, China, 610041
- Recruiting
- Sichuan Cancer Hospital
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Chengdu, Sichuan, China, 611135
- Recruiting
- West China Hospital Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
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-
Yunnan
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Kunming, Yunnan, China, 650118
- Recruiting
- Yunnan Cancer Hospital
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310005
- Recruiting
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Nantong, Zhejiang, China, 226361
- Recruiting
- Nantong Tumor Hospital
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Taizhou, Zhejiang, China, 317099
- Recruiting
- Taizhou Hospital of Zhejiang Province
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-
-
-
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Barranquilla, Colombia
- Recruiting
- Centro Cancerologico del Caribe LTDA CECAC
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Antioquia
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Medellín, Antioquia, Colombia, 050030
- Recruiting
- Fundacion Colombiana de Cancerologia Clinica Vida
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
- Recruiting
- Sociedad de Oncologia y Hematologia del Cesar
-
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Cundinamarca
-
Bogota, Cundinamarca, Colombia, 111711
- Recruiting
- Instituto Nacional De Cancerologia
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Bogotá, Cundinamarca, Colombia, 110131
- Recruiting
- Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia
- Recruiting
- Instituto Medico de Alta Tecnologia sas - Imat sas
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Risaralda Department
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Pereira, Risaralda Department, Colombia, 660001
- Recruiting
- Oncologos del Occidente SAS
-
-
Santander Department
-
Bucaramanga, Santander Department, Colombia, 681017
- Recruiting
- Fundacion Cardiovascular de Colombia
-
-
-
-
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Brno, Czechia, 625 00
- Terminated
- Fakultni Nemocnice Brno
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Olomouc, Czechia, 779 00
- Recruiting
- Fakultni nemocnice Olomouc
-
Pilsen, Czechia, 305 99
- Recruiting
- Fakultni Nemocnice Plzen
-
-
-
-
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Aarhus N, Denmark, 8200
- Terminated
- Aarhus Universitetshospital
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Copenhagen, Denmark, 2100
- Terminated
- Rigshospitalet
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Herning, Denmark, 7400
- Recruiting
- Regionshospitalet Godstrup
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Sønderborg, Denmark, 6400
- Terminated
- Sonderborg Sygehus
-
Vejle, Denmark, 7100
- Terminated
- Vejle Sygehus
-
-
-
-
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Besançon, France, 25030
- Recruiting
- Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
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Boulogne-Billancourt, France, 92104
- Recruiting
- Centre Hospitalier Universitaire Ambroise Pare
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Caen, France, 14000
- Recruiting
- Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
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Créteil, France, 94010
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
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La Roche-sur-Yon, France, 85925
- Recruiting
- Centre Hospitalier Departemental Les Oudairies
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Le Mans, France, 72000
- Recruiting
- Centre Hospitalier - Le Mans
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Lille, France, 59037
- Recruiting
- Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
-
Marseille, France, 13915
- Recruiting
- Centre Hospitalier Universitaire Nord
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Montpellier, France, 34070
- Recruiting
- Centre de Cancerologie du Grand Montpellier-Clinique Clementville
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Nantes, France, 44277
- Recruiting
- Hôpital privé du Confluent
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Nice, France, 06189
- Recruiting
- Centre Antoine Lacassagne
-
Nîmes, France, 30029
- Recruiting
- Hopital Universitaire Caremeau
-
Paris, France, 75005
- Recruiting
- Institut Curie
-
Paris, France, 75014
- Recruiting
- Hôpital Cochin
-
Paris, France, 75014
- Recruiting
- Groupe Hospitalier Paris Saint Joseph
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Paris, France, 75020
- Recruiting
- Hopital Tenon
-
Pessac, France, 33604
- Terminated
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
-
Poitiers, France, 86021
- Recruiting
- Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
-
Quimper, France, 29000
- Recruiting
- Centre Hospitalier de Cornouaille
-
Reims, France, 51092
- Recruiting
- Centre Hospitalier Universitaire de Reims - Hopital Christian Cabrol
-
Rennes, France, 35033
- Recruiting
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, France, 76031
- Recruiting
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Saint-Priest-en-Jarez, France, 42270
- Recruiting
- Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
-
Strasbourg, France, 67091
- Recruiting
- Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
-
Toulon, France, 83800
- Recruiting
- Hopital d instruction des armees sainte anne
-
Toulouse, France, 31059
- Recruiting
- Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
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Tours, France, 37044
- Recruiting
- Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
-
Villefranche-sur-Saône, France, 69400
- Recruiting
- Hopital Nord Ouest Villefranche sur Saone
-
Villejuif, France, 94805
- Recruiting
- Gustave Roussy
-
-
-
-
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Chemnitz, Germany, 09113
- Recruiting
- Klinikum Chemnitz GmbH
-
Gauting, Germany, 82130
- Completed
- Asklepios Fachkliniken Muenchen Gauting
-
Göttingen, Germany, 37075
- Recruiting
- Universitaetsmedizin Goettingen
-
Kempten, Germany, 87439
- Recruiting
- Klinikverbund Allgaeu
-
München, Germany, 80366
- Completed
- Klinikum der LMU Muenchen
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-
-
-
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Athens, Greece, 18547
- Recruiting
- Metropolitan Hospital
-
Athens, Greece, 11526
- Recruiting
- Henry Dunant Hospital Center
-
Athens, Greece, 11525
- Recruiting
- 251 General Airforce Hospital
-
Athens, Greece, 11528
- Recruiting
- Alexandra Hospital
-
Athens, Greece, 15123
- Recruiting
- Iaso Hospital
-
Athens, Greece, 12462
- Terminated
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
-
Marousi, Greece, 15123
- Terminated
- Iaso General Clinic
-
Piraeus, Greece, 18537
- Recruiting
- Metaxa Anticancer Hospital
-
Thessaloniki, Greece, 57001
- Recruiting
- European Interbalkan Medical Center
-
Thessaloniki, Greece, 55236
- Recruiting
- Agios Loukas Clinic
-
Thessaloniki, Greece, 54007
- Recruiting
- Theagenion Cancer Hospital
-
-
-
-
-
Hong Kong, Hong Kong
- Terminated
- Queen Mary Hospital, The University of Hong Kong
-
Kowloon, Hong Kong
- Recruiting
- Queen Elizabeth Hospital, Hong Kong
-
Kowloon, Hong Kong
- Terminated
- Princess Margaret Hospital
-
-
-
-
-
Budapest, Hungary, 1121
- Recruiting
- Orszagos Koranyi Pulmonologiai Intezet
-
Budapest, Hungary, 1145
- Recruiting
- Budapesti Uzsoki Utcai Kórház
-
Farkasgyepű, Hungary, 8582
- Recruiting
- Farkasgyepui Tudogyogyintezet
-
Gyöngyös, Hungary, 3200
- Recruiting
- Matrai Gyogyintezet
-
Győr, Hungary, 9024
- Recruiting
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
-
Szolnok, Hungary, 5000
- Recruiting
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
-
Székesfehérvár, Hungary, 8000
- Recruiting
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
-
Tatabánya, Hungary, 2800
- Terminated
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
-
Törökbálint, Hungary, 2045
- Recruiting
- Református Pulmonológiai Centrum
-
-
-
-
-
Bari, Italy, 70124
- Recruiting
- IRCCS Istituto Tumori Giovanni Paolo II
-
Brescia, Italy, 25123
- Recruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
-
Candiolo, Italy, 10060
- Recruiting
- Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
-
Catania, Italy, 95123
- Recruiting
- Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico
-
Florence, Italy, 50134
- Recruiting
- Azienda Ospedaliero Universitaria Careggi
-
Meldola (FC), Italy, 47014
- Recruiting
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
-
Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Monza (MB), Italy, 20900
- Terminated
- Fondazione IRCCS San Gerardo dei Tintori
-
Naples, Italy, 80131
- Recruiting
- Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
-
Naples, Italy, 80138
- Recruiting
- Azienda Ospedaliero Universitaria Luigi Vanvitelli
-
Parma, Italy, 43126
- Recruiting
- Azienda Ospedaliero-Universitaria di Parma
-
Perugia, Italy, 06156
- Recruiting
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
-
Pesaro, Italy, 61122
- Recruiting
- Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
-
Pisa, Italy, 56124
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
-
Rome, Italy, 00144
- Recruiting
- IRCCS Istituti Fisioterapici Ospitalieri
-
Udine, Italy, 33100
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Recruiting
- Nagoya University Hospital
-
-
Aomori
-
Hirosaki-shi, Aomori, Japan, 036-8563
- Recruiting
- Hirosaki University Hospital
-
-
Chiba
-
Chiba, Chiba, Japan, 260-8717
- Recruiting
- Chiba cancer center
-
Kashiwa-shi, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-0280
- Recruiting
- National Hospital Organization Shikoku Cancer Center
-
Toon-shi, Ehime, Japan, 791-0295
- Recruiting
- Ehime University Hospital
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 811-1395
- Recruiting
- National Hospital Organization Kyushu Cancer Center
-
Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Recruiting
- Hospital of the University of Occupational and Environmental Health, Japan
-
Kurume-shi, Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University Hospital
-
-
Hiroshima
-
Fukuyama-shi, Hiroshima, Japan, 720-0001
- Recruiting
- Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 003-0804
- Recruiting
- National Hospital Organization Hokkaido Cancer Center
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0046
- Recruiting
- Kobe Minimally invasive Cancer Center
-
Takarazuka-shi, Hyōgo, Japan, 665-0827
- Recruiting
- Takarazuka City Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8641
- Recruiting
- Kanazawa University Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 216-8511
- Recruiting
- St Marianna University Hospital
-
Yokohama, Kanagawa, Japan, 241-8515
- Recruiting
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
-
-
Kyoto
-
Kyoto, Kyoto, Japan, 606-8507
- Recruiting
- Kyoto University Hospital
-
-
Miyagi
-
Natori-shi, Miyagi, Japan, 981-1293
- Recruiting
- Miyagi Cancer Center
-
Sendai, Miyagi, Japan, 981-0914
- Recruiting
- Sendai Kousei Hospital
-
-
Niigata
-
Niigata, Niigata, Japan, 951-8566
- Recruiting
- Niigata Cancer Center Hospital
-
-
Okayama-ken
-
Okayama, Okayama-ken, Japan, 700-8558
- Recruiting
- Okayama University Hospital
-
-
Osaka
-
Hirakata-shi, Osaka, Japan, 573-1191
- Recruiting
- Kansai Medical University Hospital
-
Osaka, Osaka, Japan, 541-8567
- Recruiting
- Osaka International Cancer Institute
-
Sakai-shi, Osaka, Japan, 591-8555
- Recruiting
- National Hospital Organization Kinki-Chuo Chest Medical Center
-
Sakai-shi, Osaka, Japan, 590-0197
- Recruiting
- Kindai University Hospital
-
-
Saitama
-
Kitaadachi-gun, Saitama, Japan, 362-0806
- Recruiting
- Saitama Cancer Center
-
-
Shizuoka
-
Sunto-gun, Shizuoka, Japan, 411-8777
- Recruiting
- Shizuoka Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Recruiting
- Juntendo University Hospital
-
Koto-ku, Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research
-
-
Tottori
-
Yonago-shi, Tottori, Japan, 683-8504
- Recruiting
- Tottori University Hospital
-
-
Wakayama
-
Wakayama, Wakayama, Japan, 641-8510
- Recruiting
- Wakayama Medical University Hospital
-
-
Yamaguchi
-
Ube-shi, Yamaguchi, Japan, 755-0241
- Recruiting
- National Hospital Organization Yamaguchi-Ube Medical Center
-
-
-
-
-
Riga, Latvia, 1002
- Completed
- Pauls Stradins Clinical University Hospital
-
Riga, Latvia, 1079
- Terminated
- Riga East Clinical University Hospital
-
-
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Recruiting
- Pantai Hospital Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
-
-
Pahang
-
Kuantan, Pahang, Malaysia, 25100
- Recruiting
- Hospital Tengku Ampuan Afzan
-
-
-
-
-
Guadalajara, Mexico, 44680
- Recruiting
- Actualidad Basada En La Investigacion Del Cancer
-
Oaxaca City, Mexico, 68020
- Recruiting
- Centro de Investigacion Clinica de Oaxaca
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44280
- Recruiting
- Hospital Civil de Guadalajara Fray Antonio Alcalde
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 03100
- Recruiting
- Health Pharma Professional Research SA de CV
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Recruiting
- Hospital Universitario Dr Jose Eleuterio Gonzalez
-
Monterrey, Nuevo León, Mexico, CP66220
- Recruiting
- Oncare
-
-
-
-
-
Amersfoort, Netherlands, 3813 TZ
- Recruiting
- Meander Medisch Centrum
-
Groningen, Netherlands, 9713 GZ
- Recruiting
- Universitair Medisch Centrum Groningen
-
Harderwijk, Netherlands, 3844 DG
- Terminated
- Sint Jansdal Ziekenhuis
-
Maastricht, Netherlands, 6229 HX
- Recruiting
- Maastricht Universitair Medisch Centrum
-
Tilburg, Netherlands, 5022 GC
- Recruiting
- Elisabeth-Tweesteden Ziekenhuis
-
Zwolle, Netherlands, 8025 AB
- Recruiting
- Isala Klinieken
-
-
-
-
-
Arequipa, Peru, 04001
- Recruiting
- Centro de Investigacion Vallesur
-
Cusco, Peru, 08003
- Recruiting
- Hospital Nacional Adolfo Guevara Velasco
-
Lima, Peru, 15036
- Recruiting
- Oncosalud
-
Lima, Peru, 15801
- Recruiting
- Hospital de Apoyo Departamental Maria Auxiliadora
-
Lima, Peru, 15036
- Recruiting
- Unidad de Investigación Clínica Internacional Sede San Borja
-
-
-
-
-
Bialystok, Poland, 15-540
- Recruiting
- Uniwersytecki Szpital Kliniczny W Bialymstoku
-
Bystra, Poland, 43-360
- Recruiting
- Centrum Pulmonologii i Torakochirurgii w Bystrej
-
Gdynia, Poland, 81-519
- Recruiting
- Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
-
Krakow, Poland, 31-826
- Terminated
- Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
-
Lodz, Poland, 93-338
- Recruiting
- Instytut Centrum Zdrowia Matki Polki
-
Lublin, Poland, 20-090
- Recruiting
- Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie
-
Poznan, Poland, 60-693
- Terminated
- Med Polonia Sp zoo
-
Przemyśl, Poland, 37-700
- Recruiting
- Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
-
Warsaw, Poland, 02-781
- Recruiting
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
-
-
-
-
-
Lisbon, Portugal, 1400-038
- Recruiting
- Fundação Champalimaud
-
Lisbon, Portugal, 1350-352
- Recruiting
- Hospital Cuf Tejo
-
Lisbon, Portugal, 1769-001
- Recruiting
- Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
-
Lisbon, Portugal, 1500-650
- Terminated
- Hospital da Luz, SA
-
Matosinhos Municipality, Portugal, 4464-513
- Recruiting
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
-
Porto, Portugal, 4100-180
- Terminated
- Hospital CUF Porto
-
-
-
-
-
Ponce, Puerto Rico, 00730
- Recruiting
- Pan American Center for Oncology Trials
-
-
-
-
-
Bucharest, Romania, 022328
- Recruiting
- Institutul Oncologic, Prof Dr Alexandru Trestioreanu
-
Bucharest, Romania, 050098
- Recruiting
- Spitalul Universitar de Urgenta Bucuresti
-
Cluj-Napoca, Romania, 400015
- Recruiting
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
-
Cluj-Napoca, Romania, 400641
- Recruiting
- SC Medisprof SRL
-
Craiova, Romania, 200542
- Recruiting
- Centrul de Oncologie Sf Nectarie SRL
-
Iași, Romania, 700483
- Recruiting
- Institutul Regional de Oncologie Iasi
-
Ploieşti, Romania, 100337
- Recruiting
- Spitalul Municipal Ploiesti
-
Timișoara, Romania, 300239
- Recruiting
- SC Oncomed SRL
-
-
-
-
-
Singapore, Singapore, 308433
- Recruiting
- Tan Tock Seng Hospital
-
Singapore, Singapore, 119228
- Recruiting
- National University Hospital
-
-
-
-
-
Busan, South Korea, 49241
- Recruiting
- Pusan National University Hospital
-
Goyang-si Gyeonggi-do, South Korea, 10408
- Recruiting
- National Cancer Center
-
Incheon, South Korea, 21565
- Recruiting
- Gachon University Gil Medical Center
-
Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Seoul, South Korea, 02841
- Terminated
- Korea University Anam Hospital
-
Seoul, South Korea, 08308
- Terminated
- Korea University Guro Hospital
-
Yangsan-si, Gyeongsangnam-do, South Korea, 50612
- Recruiting
- Pusan National University Yangsan Hospital
-
-
-
-
-
Madrid, Spain, 28040
- Recruiting
- Hospital Clínico San Carlos
-
Madrid, Spain, 28040
- Recruiting
- Fundación Jiménez Díaz
-
Madrid, Spain, 28046
- Terminated
- Hospital Universitario La Paz
-
-
Andalusia
-
Málaga, Andalusia, Spain, 29011
- Recruiting
- Hospital Regional Universitario de Malaga
-
Seville, Andalusia, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
-
-
Aragon
-
Zaragoza, Aragon, Spain, 50009
- Terminated
- Hospital Clinico Universitario Lozano Blesa
-
-
Canary Islands
-
Las Palmas de Gran Canaria, Canary Islands, Spain, 35016
- Recruiting
- Hospital Universitario Insular de Gran Canaria
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Recruiting
- Hospital Universitario Marqués de Valdecilla
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08003
- Recruiting
- Hospital del Mar
-
Barcelona, Catalonia, Spain, 08041
- Recruiting
- Hospital De La Santa Creu I Sant Pau
-
Barcelona, Catalonia, Spain, 08035
- Recruiting
- Hospital Universitari Vall d Hebron
-
Barcelona, Catalonia, Spain, 08036
- Recruiting
- Hospital Clinic i Provincial de Barcelona
-
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
- Recruiting
- Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
-
-
Galicia
-
A Coruña, Galicia, Spain, 15006
- Recruiting
- Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
-
-
Madrid
-
Majadahonda, Madrid, Spain, 28222
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
Valencia
-
Valencia, Valencia, Spain, 46010
- Recruiting
- Hospital Clinico Universitario de Valencia
-
Valencia, Valencia, Spain, 46026
- Recruiting
- Hospital Universitari i Politecnic La Fe
-
-
-
-
-
Gothenburg, Sweden, 413 45
- Terminated
- Sahlgrenska Universitetssjukhuset
-
Gävle, Sweden, 801 87
- Terminated
- Gävle sjukhus
-
Umeå, Sweden, 901 85
- Recruiting
- Norrlands universitetssjukhus
-
-
-
-
-
Aarau, Switzerland, 5001
- Terminated
- Kantonsspital Aarau
-
Baden, Switzerland, 5404
- Recruiting
- Kantonsspital Baden
-
Basel, Switzerland, 4031
- Terminated
- Universitaetsspital Basel
-
Zurich, Switzerland, 8091
- Recruiting
- Universitaetsspital Zuerich
-
-
-
-
-
Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
-
Taichung, Taiwan, 40705
- Recruiting
- Veterans General Hospital - Taichung
-
Tainan, Taiwan, 70403
- Recruiting
- National Cheng Kung University Hospital
-
Tainan, Taiwan, 73657
- Recruiting
- Chi Mei Hospital, Liouying
-
Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital
-
Taoyuan, Taiwan, 33305
- Recruiting
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Bangkok, Thailand, 10330
- Recruiting
- King Chulalongkorn Memorial Hospital
-
Bangkok, Thailand, 10400
- Recruiting
- Phramongkutklao Hospital
-
Bangkok, Thailand, 10300
- Recruiting
- Vajira Hospital
-
Chiang Mai, Thailand, 50200
- Recruiting
- Maharaj Nakorn Chiang Mai Hospital
-
Khon Kaen, Thailand, 40002
- Recruiting
- Srinagarind Hospital
-
Samut Sakhon, Thailand, 74120
- Recruiting
- Banphaeo General Hospital
-
Songkhla, Thailand, 90110
- Recruiting
- Songklanagarind Hospital
-
-
-
-
-
Adana, Turkey (Türkiye), 01140
- Recruiting
- Medical Park Seyhan Hastanesi
-
Adana, Turkey (Türkiye), 01250
- Recruiting
- Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
-
Ankara, Turkey (Türkiye), 06800
- Recruiting
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turkey (Türkiye), 06560
- Recruiting
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
-
Ankara, Turkey (Türkiye), 06230
- Recruiting
- Hacettepe Universitesi Tip Fakultesi Hastanesi
-
Antalya, Turkey (Türkiye), 07050
- Recruiting
- Akdeniz Universitesi Tip Fakultesi
-
Aydin, Turkey (Türkiye), 09100
- Recruiting
- Aydin Adnan Menderes Universitesi Tip Fakultesi
-
Denizli, Turkey (Türkiye), 20070
- Terminated
- Pamukkale Universitesi Tip Fakultesi Hastanesi
-
Istanbul, Turkey (Türkiye), 34214
- Recruiting
- Bagcilar Medipol Mega Universite Hastanesi
-
Istanbul, Turkey (Türkiye), 34722
- Recruiting
- Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
-
Istanbul, Turkey (Türkiye), 34098
- Recruiting
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
-
Istanbul, Turkey (Türkiye), 34865
- Recruiting
- Kartal Dr Lutfi Kirdar Sehir Hastanesi
-
Istanbul, Turkey (Türkiye), 34890
- Terminated
- Marmara Universitesi Tip Fakultesi Hastanesi
-
Istanbul, Turkey (Türkiye), 34180
- Terminated
- Memorial Bahcelievler Hastanesi
-
Istanbul, Turkey (Türkiye), 34384
- Recruiting
- Prof Dr Cemil Tascioglu Sehir Hastanesi
-
Izmir, Turkey (Türkiye), 35575
- Recruiting
- Izmir Ekonomi Universitesi Medical Point Hastanesi
-
Izmir, Turkey (Türkiye), 35110
- Recruiting
- Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
-
Samsun, Turkey (Türkiye), 55200
- Terminated
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital Birmingham
-
Inverness, United Kingdom, IV2 3UJ
- Terminated
- Raigmore Hospital
-
London, United Kingdom, SW3 6JJ
- Recruiting
- Royal Marsden Hospital
-
Northwood, United Kingdom, HA6 2RN
- Recruiting
- Mount Vernon Cancer Centre
-
Nottingham, United Kingdom, NG5 1PB
- Recruiting
- Nottingham City Hospital
-
Sutton, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital
-
Torquay, United Kingdom, TQ2 7AA
- Recruiting
- Torbay Hospital
-
Truro, United Kingdom, TR1 3LQ
- Recruiting
- Royal Cornwall Hospital
-
-
-
-
California
-
Santa Barbara, California, United States, 93105
- Recruiting
- Sansum Clinic
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Recruiting
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois Chicago
-
Niles, Illinois, United States, 60714
- Recruiting
- Illinois Cancer Specialists
-
-
Kentucky
-
Louisville, Kentucky, United States, 40241
- Completed
- Norton Cancer Institute - Brownsboro
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01606
- Recruiting
- Reliant Medical Group Inc
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Recruiting
- University of New Mexico Cancer Center
-
-
New York
-
New York, New York, United States, 10065
- Terminated
- Memorial Sloan Kettering Cancer Center
-
-
North Carolina
-
Asheville, North Carolina, United States, 28806
- Recruiting
- Messino Cancer Centers Asheville
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Pinehurst, North Carolina, United States, 28374
- Recruiting
- FirstHealth Cancer Center
-
-
Pennsylvania
-
Media, Pennsylvania, United States, 19063
- Recruiting
- Alliance Cancer Specialists - Media
-
Pittsburgh, Pennsylvania, United States, 15232
- Terminated
- University of Pittsburgh Medical Center
-
-
Tennessee
-
Memphis, Tennessee, United States, 38103
- Recruiting
- Regional One Health
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute
-
Nashville, Tennessee, United States, 37203
- Recruiting
- United States Oncology Regulatory Affairs Corporate Office
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
-
Houston, Texas, United States, 77030
- Recruiting
- Oncology Consultants PA
-
Irving, Texas, United States, 75063
- Recruiting
- US Oncology Research Investigational Products Center
-
-
Washington
-
Olympia, Washington, United States, 98506
- Recruiting
- Vista Oncology Inc PS
-
-
Wisconsin
-
Janesville, Wisconsin, United States, 53548
- Recruiting
- Mercyhealth
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
- No history of systemic anticancer therapy in metastatic/non-curable settings
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion Criteria:
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- Symptomatic (treated or untreated) brain metastases
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
- Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- Prior therapy with a KRAS G12C inhibitor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sotorasib combined with carboplatin and pemetrexed
Sotorasib administered in combination with carboplatin and pemetrexed.
|
Oral administration
Other Names:
|
|
Active Comparator: Pembrolizumab combined with carboplatin and pemetrexed
Pembrolizumab administered in combination with carboplatin and pemetrexed.
|
Intravenous administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free Survival (PFS)
Time Frame: Approximately 2.5 years
|
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first.
Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
|
Approximately 2.5 years
|
|
Overall Survival (OS)
Time Frame: Approximately 2.5 years
|
OS is defined as the time from randomization until death due to any cause.
|
Approximately 2.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in QLQ-LC13 Symptoms of Cough Subscale
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in Physical Function as Measured by QLQ-C30
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in Global Health Status as Measured by QLQ-C30
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in QLQ-LC13 Subscale Scores
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
From Baseline up to EOS (approximately 5.5 years)
|
|
|
Change in QLQ-C30 Subscale Scores
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
From Baseline up to EOS (approximately 5.5 years)
|
|
|
Time to Deterioration in QLC-LC13 Subscale Scores
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Time to Deterioration in QLC-C30 Subscale Scores
Time Frame: From Baseline to Week 12
|
From Baseline to Week 12
|
|
|
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Measured by EuroQol-5 Dimension (EQ-5D-5L).
|
From Baseline up to EOS (approximately 5.5 years)
|
|
Duration of Response
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
|
From Baseline up to EOS (approximately 5.5 years)
|
|
Time to Response
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Defined as the time from randomization to first evidence of PR or CR per BICR.
|
From Baseline up to EOS (approximately 5.5 years)
|
|
Disease Control
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.
|
From Baseline up to EOS (approximately 5.5 years)
|
|
PFS
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Based on investigator tumor assessments per RECIST v1.1.
|
From Baseline up to EOS (approximately 5.5 years)
|
|
Objective Response
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
Based on investigator tumor assessments per RECIST v1.1.
|
From Baseline up to EOS (approximately 5.5 years)
|
|
Number of Participants With Treatment-Emergent Adverse Events
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
From Baseline up to EOS (approximately 5.5 years)
|
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
From Baseline up to EOS (approximately 5.5 years)
|
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
From Baseline up to EOS (approximately 5.5 years)
|
|
|
Maximum Plasma Concentration (Cmax) of Sotorasib
Time Frame: Pre-dose Day 1 up to Day 64
|
Pre-dose Day 1 up to Day 64
|
|
|
Minimum Plasma Concentration (Cmin) of Sotorasib
Time Frame: Pre-dose Day 1 up to Day 64
|
Pre-dose Day 1 up to Day 64
|
|
|
Area Under The Curve (AUC) of Sotorasib
Time Frame: Pre-dose Day 1 up to Day 64
|
Pre-dose Day 1 up to Day 64
|
|
|
Objective Response Rate (ORR)
Time Frame: From Baseline up to end of study (EOS) (approximately 5.5 years)
|
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.
|
From Baseline up to end of study (EOS) (approximately 5.5 years)
|
|
Progression-free Survival 2 (PFS2)
Time Frame: From Baseline up to EOS (approximately 5.5 years)
|
PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first.
|
From Baseline up to EOS (approximately 5.5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 29, 2032
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- pembrolizumab
- sotorasib
Other Study ID Numbers
- 20190341
- 2022-501863-41-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
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 Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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