This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1. (Be6A Lung-02)
April 17, 2026 updated by: Pfizer
AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)
The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control.
The study is seeking for participants who:
- Are confirmed to have NSCLC (Stage 3 or 4).
- Have PD-L1 levels in more than 50% of the cancer cells.
All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.
Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
714
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: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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Buenos Aires, Argentina, 1426
- Recruiting
- Centro Oncologico Korben
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Buenos Aires, Argentina, C1122AAL
- Not yet recruiting
- Instituto Argentino de Diagnóstico y Tratamiento (IADT)
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Córdoba, Argentina, 5000
- Not yet recruiting
- Centro Urologico Profesor Bengio
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Córdoba, Argentina, 5016
- Not yet recruiting
- Hospital Privado Universitario de Cordoba
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Córdoba, Argentina, 5000
- Not yet recruiting
- Sanatorio Privado de la Cañada
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Córdoba, Argentina, X5008AAC
- Not yet recruiting
- Centro Medico Privado CEMAIC
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San Juan, Argentina, 5400
- Not yet recruiting
- Instituto San Marcos
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
- Not yet recruiting
- Fundación Respirar
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Pergamino, Buenos Aires, Argentina, B2700CPM
- Not yet recruiting
- Centro de Investigación Pergamino
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Cdad. Autónoma de Buenos Aires
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Buenos Aires, Cdad. Autónoma de Buenos Aires, Argentina, C 1113
- Recruiting
- Centro de Investigaciones Medicas y Desarrollo LC
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Jujuy Province
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San Salvador de Jujuy, Jujuy Province, Argentina, 4600
- Not yet recruiting
- Fundación Ars Médica
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Río Negro Province
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Cipolletti, Río Negro Province, Argentina, 8324
- Recruiting
- Fundacion Medica de Rio Negro y Neuquen
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Not yet recruiting
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, S2000CVB
- Not yet recruiting
- Sanatorio Británico
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Not yet recruiting
- Sanatorio Parque
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Rosario, Santa Fe Province, Argentina, S2002KDS
- Not yet recruiting
- Hospital Provincial del Centenario
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New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
- Recruiting
- Coffs Harbour Health Campus
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North Ryde, New South Wales, Australia, 2109
- Recruiting
- Macquarie University
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Sydney, New South Wales, Australia, 2560
- Recruiting
- Campbelltown Hospital
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Queensland
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Birtinya, Queensland, Australia, 4575
- Recruiting
- Sunshine Coast University Hospital
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Douglas, Queensland, Australia, 4814
- Recruiting
- Townsville University Hospital
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Gympie, Queensland, Australia, 4570
- Recruiting
- Gympie Hospital
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Nambour, Queensland, Australia, 4560
- Recruiting
- Nambour General Hospital
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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Western Australia
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Perth, Western Australia, Australia, 6009
- Recruiting
- Sir Charles Gairdner Hospital
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Graz, Austria, 8036
- Not yet recruiting
- Medizinische Universität Graz
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Vienna, Austria, 1090
- Not yet recruiting
- Medizinische Universität Wien
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Recruiting
- Ordensklinikum Linz GmbH Elisabethinen
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Brasschaat, Belgium, 2930
- Recruiting
- Algemeen Ziekenhuis klina
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Liège, Belgium, 4000
- Recruiting
- Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
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Antwerpen
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Mechelen, Antwerpen, Belgium, 2800
- Recruiting
- Az Sint-Maarten
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Bruxelles-capitale, Région de
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Brussels, Bruxelles-capitale, Région de, Belgium, 1090
- Recruiting
- UZ Brussel
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Hainaut
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Charleroi, Hainaut, Belgium, 6060
- Recruiting
- Grand Hôpital de Charleroi
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Jaú, Brazil, 17210-080
- Not yet recruiting
- Fundação Doutor Amaral Carvalho
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São Paulo, Brazil, 01246-000
- Not yet recruiting
- Icesp - Instituto Do Câncer Do Estado de São Paulo
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Ceará
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Fortaleza, Ceará, Brazil, 60430235
- Recruiting
- Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
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Fortaleza, Ceará, Brazil, 60336232
- Recruiting
- Crio - Centro Regional Integrado de Oncologia
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29043-260
- Recruiting
- Afecc Associacao Feminina Educacao Combate Cancer
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 41950- 640
- Recruiting
- Clinica Amo - Rio Vermelho
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Salvador, Estado de Bahia, Brazil, 41253-190
- Recruiting
- Instituto D'Or de Pesquisa e Ensino - Hospital Sao Rafael
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Federal District
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Brasília, Federal District, Brazil, 70390-150
- Not yet recruiting
- Onco-Vida - Instituto Especializado De Oncologia
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Paraná
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Curitiba, Paraná, Brazil, 81520-060
- Recruiting
- Hospital Erasto Gaertner
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Pernambuco
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Recife, Pernambuco, Brazil, 52010-075
- Recruiting
- Real Hospital Portugues
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Piauí
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Teresina, Piauí, Brazil, 64049-200
- Recruiting
- Vencer Centro de Pesquisa LTDA
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil, 59062-000
- Recruiting
- Liga Norte Riograndense Contra o Câncer
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Recruiting
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia
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Porto Alegre, Rio Grande do Sul, Brazil, 90560032
- Not yet recruiting
- Hospital Moinhos de Vento
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Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Not yet recruiting
- Hospital Sao Lucas Da Pucrs
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São Paulo
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Barretos, São Paulo, Brazil, 14784400
- Recruiting
- Fundação Pio XII - Hospital de Câncer de Barretos
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Ribeirão Preto, São Paulo, Brazil, 14051-140
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
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Santo André, São Paulo, Brazil, 09060-650
- Not yet recruiting
- Faculdade de Medicina do ABC
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São José do Rio Preto, São Paulo, Brazil, 15090000
- Recruiting
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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São Paulo, São Paulo, Brazil, 01327-001
- Recruiting
- Hospital Alemao Oswaldo Cruz
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Burgas, Bulgaria, 8000
- Recruiting
- Complex Oncology Center - Burgas
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Plovdiv, Bulgaria, 4000
- Not yet recruiting
- Medical Center Futuremeds
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Sofia, Bulgaria, 1407
- Recruiting
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
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Sofia, Bulgaria, 1756
- Not yet recruiting
- University Specialized Hospital for Active Treatment of Oncology EAD
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Sofia, Bulgaria, 1330
- Recruiting
- MHAT for Women's Health Nadezhda
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Pazardzhik
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Panagyurishte, Pazardzhik, Bulgaria, 4500
- Recruiting
- MBAL Uni Hospital
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British Columbia
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Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
- Recruiting
- BC Cancer Abbotsford
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- CIUSSS de l'Est-de-l'Île-de-Montréal
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Saint-Jérôme, Quebec, Canada, J7Y 0L1
- Recruiting
- Centre de Services Ambulatoire de St-Jerome
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Saint-Jérôme, Quebec, Canada, J7Z 2V4
- Recruiting
- Unite de Recherche Clinique Du Cisss Des Laurentides
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Los Ríos Region
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Valdivia, Los Ríos Region, Chile, 5090000
- Recruiting
- Clínica Alemana Valdivia
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Valdivia, Los Ríos Region, Chile, 5690000
- Recruiting
- Oncocentro Valdivia
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Santiago Metropolitan
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La Florida, Santiago Metropolitan, Chile, 8241479
- Recruiting
- Iceg Clinic
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Providencia, Santiago Metropolitan, Chile, 7500966
- Recruiting
- Fundacion Arturo Lopez Perez
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Providencia, Santiago Metropolitan, Chile, 7501010
- Recruiting
- Profar
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Providencia, Santiago Metropolitan, Chile, 750000
- Recruiting
- Fundacion Arturo Lopez Perez
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Providencia, Santiago Metropolitan, Chile, 7500836
- Recruiting
- FALP
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Santiago, Santiago Metropolitan, Chile, 7500921
- Recruiting
- FALP
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Santiago, Santiago Metropolitan, Chile, 8241479
- Recruiting
- Clínica Vespucio
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Santiago, Santiago Metropolitan, Chile, 8380455
- Recruiting
- Instituto Nacional del Cancer
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Santiago, Santiago Metropolitan, Chile, 8380456
- Recruiting
- Sociedad Oncovida SA
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- Recruiting
- Oncocentro Apys
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Anhui
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Hefei, Anhui, China, 230031
- Not yet recruiting
- Anhui Provincial Cancer Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Not yet recruiting
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 101149
- Recruiting
- Beijing Chest Hospital,Capital Medical University
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Fujian
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Fuzhou, Fujian, China, 350014
- Not yet recruiting
- Fujian Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Not yet recruiting
- Nanfang Hospital of Southern Medical University
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Huizhou, Guangdong, China, 516001
- Recruiting
- Huizhou Central People's Hospital
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Guangxi
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Nanning, Guangxi, China
- Recruiting
- Guangxi Medical University Affiliated Tumor Hospital
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Not yet recruiting
- Harbin Medical University Cancer Hospital
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Henan
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Luoyang, Henan, China, 471003
- Not yet recruiting
- The First Affiliated Hospital of Henan University of Science &Technology
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Zhengzhou, Henan, China, 450008
- Recruiting
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430079
- Not yet recruiting
- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430048
- Not yet recruiting
- Wuhan Union Hospital Cancer Center
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Hunan
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Changsha, Hunan, China, 410013
- Not yet recruiting
- Hunan Cancer Hospital
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- Recruiting
- The First People's Hospital of Changzhou
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Nanjing, Jiangsu, China, 210029
- Not yet recruiting
- Jiangsu Province Hospital
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Xuzhou, Jiangsu, China, 221006
- Not yet recruiting
- The Affiliated Hospital of Xuzhou Medical College
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Jiangxi
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Nanchang, Jiangxi, China, 330200
- Recruiting
- The First Affiliated Hospital of Nanchang University
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Jilin
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Changchun, Jilin, China, 130000
- Not yet recruiting
- Jilin Province Tumor Hospital
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- Not yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
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Shandong
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Jinan, Shandong, China, 250117
- Not yet recruiting
- Shandong Cancer Hospital
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Jinan, Shandong, China, 250013
- Not yet recruiting
- Jinan Central Hospital
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Linyi, Shandong, China, 276001
- Not yet recruiting
- Linyi Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, China, 200030
- Not yet recruiting
- Shanghai Chest Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- Not yet recruiting
- West China Hospital, Sichuan University
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Chengdu, Sichuan, China, 610041
- Not yet recruiting
- Sichuan Cancer Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300052
- Not yet recruiting
- Tianjin Medical University General Hospital
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Yunnan
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Kunming, Yunnan, China, 650118
- Not yet recruiting
- Yunnan Province Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Not yet recruiting
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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Taizhou, Zhejiang, China, 317000
- Recruiting
- Taizhou Hospital of Zhejiang Province
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Liberec1, Czechia, 460 01
- Recruiting
- Krajska nemocnice Liberec, a.s.
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Nový Jičín, Czechia, 741 01
- Recruiting
- Nemocnice AGEL Nový Jičín a.s.
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Olomouc, Czechia, 779 00
- Recruiting
- Fakultni nemocnice Olomouc
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Prague, Czechia, 150 00
- Recruiting
- Fakultni nemocnice Motol a Homolka
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Praha 4
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Prague, Praha 4, Czechia, 140 59
- Recruiting
- Fakultni Thomayerova nemocnice
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Marseille, France, 13915
- Recruiting
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
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Nice, France, 06189
- Recruiting
- Centre Antoine Lacassagne
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Paris, France, 75248
- Recruiting
- Institut Curie
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Paris, France, 75014
- Recruiting
- Hopitaux Universitaires Paris Centre-Hopital Cochin
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Aquitaine
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Pessac, Aquitaine, France, 33604
- Recruiting
- CHU Bordeaux Haut-Leveque
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Finistère
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Quimper, Finistère, France, 29107
- Recruiting
- Centre Hospitalier de Cornouaille Quimper - Concarneau
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Haute-garonne
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Toulouse, Haute-garonne, France, 31059
- Recruiting
- CHU de Toulouse - Hopital Larrey
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Ille-et-vilaine
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Rennes, Ille-et-vilaine, France, 35033
- Recruiting
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Languedoc-roussillon
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Montpellier, Languedoc-roussillon, France, 34070
- Recruiting
- Centre de Cancerologie du Grand Montpellier
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Loire-atlantique
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Saint-Herblain, Loire-atlantique, France, 44805
- Recruiting
- Institut de Cancérologie de l'Ouest
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Saint-Herblain, Loire-atlantique, France, 44800
- Recruiting
- Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
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PAYS de Loire
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Cholet, PAYS de Loire, France, 49300
- Recruiting
- Centre Hospitalier de Cholet
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Provence-Alpes-Côte d'Azur Region
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Toulon, Provence-Alpes-Côte d'Azur Region, France, 83100
- Recruiting
- Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
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Val-de-marne
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Créteil, Val-de-marne, France, 94010
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
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Berlin, Germany, 13353
- Recruiting
- Charité Campus Virchow-Klinikum
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Berlin, Germany, 13353
- Not yet recruiting
- Labor Berlin
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Berlin, Germany, 13509
- Not yet recruiting
- Vivantes Humboldt Klinikum Apotheke Nord
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Berlin, Germany, 13585
- Not yet recruiting
- Vivantes Hospital Spandau
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Gauting, Germany, 82131
- Not yet recruiting
- Asklepios Klinik Gauting GmbH
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Großhansdorf, Germany, 22927
- Recruiting
- LungenClinic Grosshansdorf
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München, Germany, 81377
- Not yet recruiting
- Radiologie München
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Bavaria
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Gröbenzell, Bavaria, Germany, 82194
- Not yet recruiting
- Johannes Apotheke Gröbenzell
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Traunstein, Bavaria, Germany, 83278
- Recruiting
- Klinikum Traunstein
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Hesse
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Giessen, Hesse, Germany, 35392
- Recruiting
- UKGM Gießen/Marburg
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Kassel, Hesse, Germany, 34125
- Not yet recruiting
- Klinikum Kassel
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Rhineland-Palatinate
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Koblenz, Rhineland-Palatinate, Germany, 56068
- Recruiting
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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Saxony
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Chemnitz, Saxony, Germany, 09116
- Recruiting
- Klinikum Chemnitz - Flemmingstraße
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Chemnitz, Saxony, Germany, 09113
- Recruiting
- Klinikum Chemnitz Ggmbh
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Schleswig-Holstein
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Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
- Recruiting
- ohO Research GmbH
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Athens, Greece, 115 26
- Recruiting
- Errikos Dunant Hospital Center
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Larissa, Greece, 41110
- Recruiting
- University General Hospital of Larissa, Urology Department
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Thessaloniki, Greece, 552 36
- Recruiting
- Agios Loukas Clinic
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Attikí
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Athens, Attikí, Greece, 115 27
- Recruiting
- Thoracic General Hospital of Athens "I Sotiria"
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Athens, Attikí, Greece, 155 62
- Recruiting
- Metropolitan General Hospital
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Athens, Attikí, Greece, 185 47
- Recruiting
- Metropolitan Hospital
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Marousi, Attikí, Greece, 151 23
- Recruiting
- Hygeia Hospital
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Thessaloníki
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Thessaloniki, Thessaloníki, Greece, 570 01
- Recruiting
- European Interbalkan Medical Center
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Székesfehérvár, Hungary, 8000
- Not yet recruiting
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
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Tatabánya, Hungary, 2800
- Not yet recruiting
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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Veszprém megye
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Farkasgyepű, Veszprém megye, Hungary, 8582
- Not yet recruiting
- Farkasgyepui Tudogyogyintezet
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Karnataka
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Bengaluru, Karnataka, India, 560069
- Recruiting
- Spandana Oncology Centre (SOC)
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Maharashtra
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Pune, Maharashtra, India, 411004
- Recruiting
- Sahyadri Super Speciality Hospital
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Thane, Maharashtra, India, 401107
- Recruiting
- Bhakti Vedanta Hospital and Research Institute
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110005
- Recruiting
- Dr B. L. Kapur Memorial Hospital
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New Delhi, National Capital Territory of Delhi, India, 110075
- Recruiting
- Venkateshwar Hospital
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New Delhi, National Capital Territory of Delhi, India, 110088
- Not yet recruiting
- Fortis Hospital
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Telangana
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Hyderabad, Telangana, India, 500032
- Not yet recruiting
- AIG Hospitals
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Petah Tikva, Israel, 4941492
- Recruiting
- Clalit Health Services through Rabin Medical Center
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Jerusalem
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Jerusalem, Jerusalem, Israel, 9013102
- Not yet recruiting
- Shaare Zedek Medical Center
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-
-
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Avellino, Italy, 83100
- Recruiting
- Azienda Ospedaliera San Giuseppe Moscati
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Milan, Italy, 20132
- Recruiting
- Ospedale San Raffaele
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Milan, Italy, 20141
- Recruiting
- Istituto Europeo di Oncologia IRCCS
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Padova, Italy, 35128
- Recruiting
- Istituto Oncologico Veneto IRCCS
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Campania
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Naples, Campania, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- Recruiting
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
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Piedmont
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Orbassano, Piedmont, Italy, 10043
- Recruiting
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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ROMA
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Rome, ROMA, Italy, 00144
- Recruiting
- Istituto Nazionale Tumori Regina Elena
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Rome, ROMA, Italy, 00186
- Recruiting
- Ospedale Isola Tiberina - Gemelli Isola
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Sicily
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Catania, Sicily, Italy, 95123
- Recruiting
- Policlinico "G. Rodolico"
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Fukuoka, Japan, 810-8563
- Recruiting
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 811-1395
- Recruiting
- National Hospital Organization Kyushu Cancer Center
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Kyoto, Japan, 612-8555
- Recruiting
- National Hospital Organization Kyoto Medical Center
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Okayama, Japan, 701-1154
- Recruiting
- National Hospital Organization Okayama Medical Center
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Osaka, Japan, 541-8567
- Recruiting
- Osaka International Cancer Institute
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Ehime
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Tōon, Ehime, Japan, 791-0295
- Not yet recruiting
- Ehime University Hospital
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University Hospital
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Gunma
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Otashi, Gunma, Japan, 373-8550
- Not yet recruiting
- Gunma Prefectural Cancer Center
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Hokkaido
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Asahikawa, Hokkaido, Japan, 0708644
- Recruiting
- National Hospital Organization Asahikawa Medical Center
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0047
- Recruiting
- Kobe City Medical Center General Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 2418515
- Not yet recruiting
- Kanagawa Cancer Center
-
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Mie-ken
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Tsu, Mie-ken, Japan, 514-1101
- Recruiting
- Mie Chuo Medical Center
-
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Miyagi
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Sendai, Miyagi, Japan, 9810914
- Recruiting
- Sendai Kousei Hospital
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Osaka
-
Sakai, Osaka, Japan, 591-8555
- Not yet recruiting
- NHO Kinki Chuo Chest Medical Center
-
Suita, Osaka, Japan, 565-0871
- Not yet recruiting
- The University of Osaka Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8603
- Not yet recruiting
- Nippon Medical School Hospital
-
Chuo-ku, Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
-
Koto, Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital Of JFCR
-
Meguro-Ku, Tokyo, Japan, 152-8902
- Not yet recruiting
- National Hospital Organization Tokyo Medical Center
-
-
Yamagata
-
Yamagata, Yamagata, Japan, 990-9585
- Recruiting
- Yamagata University Hospital
-
-
-
-
-
Puebla City, Mexico, 72530
- Recruiting
- Clinica Integral Internacional de Oncología
-
-
-
-
-
Utrecht, Netherlands, 3543 AZ
- Not yet recruiting
- St. Antonius Ziekenhuis, locatie Utrecht
-
-
Gelderland
-
Harderwijk, Gelderland, Netherlands, 3844 DG
- Not yet recruiting
- Ziekenhuis St. Jansdal
-
-
North Brabant
-
Breda, North Brabant, Netherlands, 4818 CK
- Not yet recruiting
- Amphia Ziekenhuis, locatie Breda Molengracht
-
-
Overijssel
-
Zwolle, Overijssel, Netherlands, 8025 AB
- Not yet recruiting
- Isala, locatie Zwolle
-
-
Provincie Friesland
-
Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
- Not yet recruiting
- Frisius Medisch Centrum
-
-
-
-
-
Gdansk, Poland, 80-214
- Not yet recruiting
- Uniwersyteckie Centrum Kliniczne
-
Gliwice, Poland, 44-102
- Not yet recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
-
Poznan, Poland, 60-569
- Recruiting
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Poland, 60-693
- Recruiting
- Med-Polonia Sp. z o. o.
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Poland, 20-609
- Recruiting
- Instytut Genetyki i Immunologii GENIM
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Poland, 02-781
- Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Poland, 90-302
- Recruiting
- Instytut MSF Sp zoo
-
-
-
-
Bucharest
-
Bucharest, Bucharest, Romania, 022338
- Not yet recruiting
- Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400641
- Recruiting
- SC Medisprof SRL
-
Florești, Cluj, Romania, 407280
- Recruiting
- SC Radiotherapy Center Cluj SRL
-
-
Constanța County
-
Ovidiu, Constanța County, Romania, 905900
- Not yet recruiting
- Ovidius Clinical Hospital OCH
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300166
- Not yet recruiting
- S C Oncocenter Oncologie Clinica S R L
-
-
-
-
-
Nové Zámky, Slovakia, 94034
- Recruiting
- Fakultna nemocnica s poliklinikou Nove Zamky
-
Poprad, Slovakia, 058 01
- Recruiting
- POKO Poprad s.r.o.
-
-
Bratislava Region
-
Bratislava, Bratislava Region, Slovakia, 821 01
- Recruiting
- Univerzitná nemocnica Bratislava - Nemocnica Ružinov
-
-
Košice Region
-
Košice, Košice Region, Slovakia, 040 01
- Recruiting
- Vychodoslovensky Onkologicky ustav a.s.
-
-
Nitra Region
-
Komárno, Nitra Region, Slovakia, 945 05
- Recruiting
- Nemocnica AGEL Komarno
-
-
Trnava Region
-
Trnava, Trnava Region, Slovakia, 917 02
- Recruiting
- Fakultna Nemocnica Trnava
-
-
-
-
Jeonranamdo
-
Hwasun-gun, Jeonranamdo, South Korea, 58128
- Recruiting
- Chonnam National University Hwasun Hospital
-
-
Kyǒnggi-do
-
Seongnam, Kyǒnggi-do, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
Suwon, Kyǒnggi-do, South Korea, 16499
- Recruiting
- Ajou University Hospital
-
Suwon, Kyǒnggi-do, South Korea, 16247
- Recruiting
- The Catholic University of Korea St. Vincent's Hospital
-
-
Pusan-kwangyǒkshi
-
Busan, Pusan-kwangyǒkshi, South Korea, 49241
- Recruiting
- Pusan National University Hospital
-
Haeundae-gu, Pusan-kwangyǒkshi, South Korea, 48108
- Recruiting
- Inje University Haeundae Paik Hospital
-
-
Seoul-teukbyeolsi [seoul]
-
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
-
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07061
- Recruiting
- Boramae Medical Center
-
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 08308
- Recruiting
- Korea University Guro Hospital
-
-
Taegu-kwangyǒkshi
-
Deagu, Taegu-kwangyǒkshi, South Korea, 41404
- Recruiting
- Kyungpook National University Chilgok Hospital
-
-
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d Hebron
-
Barcelona, Spain, 08035
- Recruiting
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (hereinafter, "VHIR")
-
Barcelona, Spain, 08035
- Recruiting
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron (hereinafter, "VHIO"
-
Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañón
-
Madrid, Spain, 28040
- Recruiting
- Hospital Universitario Fundacion Jimenez Diaz
-
Málaga, Spain, 29004
- Recruiting
- Hospital Quirón Málaga
-
Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
-
-
A Coruña [LA Coruña]
-
A Coruña, A Coruña [LA Coruña], Spain, 15006
- Recruiting
- CHUAC-Complejo Hospitalario Universitario A Coruña
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- Recruiting
- Hospital General Universitario de Elche
-
-
Barcelona [barcelona]
-
Barcelona, Barcelona [barcelona], Spain, 08028
- Recruiting
- Hospital Universitari Dexeus
-
-
Catalunya [cataluña]
-
Barcelona, Catalunya [cataluña], Spain, 08041
- Recruiting
- Hospital De La Santa Creu I Sant Pau
-
L'Hospitalet de Llobregat, Catalunya [cataluña], Spain, 08908
- Recruiting
- Institut Catala d'Oncologia - L'Hospitalet
-
-
Cádiz
-
Jerez de la Frontera, Cádiz, Spain, 11407
- Recruiting
- Hospital Jerez de la Frontera
-
-
Illes Balears [islas Baleares]
-
Palma, Illes Balears [islas Baleares], Spain, 07198
- Recruiting
- Hospital Son Llatzer
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spain, 46010
- Recruiting
- Hospital Clinico de Valencia
-
-
-
-
-
Zurich, Switzerland, 8091
- Recruiting
- UniversitätsSpital Zürich
-
-
Canton of Bern
-
Bern, Canton of Bern, Switzerland, 3010
- Recruiting
- Inselspital Bern
-
-
-
-
-
Kaohsiung City, Taiwan, 807
- Not yet recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City, Taiwan, 833401
- Not yet recruiting
- Chang Gung Memorial Hospital at Kaohsiung
-
Taichung, Taiwan, 407
- Not yet recruiting
- Taichung Veterans General Hospital
-
Tainan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10002
- Not yet recruiting
- National Taiwan University Hospital
-
-
Tainan
-
Tainan, Tainan, Taiwan, 73657
- Not yet recruiting
- Chi Mei Hospital - Liouying Branch
-
-
Taipei
-
Taipei City, Taipei, Taiwan, 106
- Not yet recruiting
- National Taiwan University Cancer Center (NTUCC)
-
-
-
-
-
Adana, Turkey (Türkiye), 01140
- Recruiting
- Adana Medical Park Seyhan Hastanesi
-
Ankara, Turkey (Türkiye), 06680
- Recruiting
- Liv Hospital Ankara
-
Ankara, Turkey (Türkiye), 06800
- Recruiting
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turkey (Türkiye), 06520
- Recruiting
- Memorial Ankara Hastanesi
-
Ankara, Turkey (Türkiye), 06230
- Recruiting
- Hacettepe Universite Hastaneleri
-
Ankara, Turkey (Türkiye), 06560
- Recruiting
- Gazi University Health Research and Application Center Gazi Hospital
-
Ankara, Turkey (Türkiye), 06010
- Recruiting
- Gulhane Egitim Arastirma Hastanesi
-
Antalya, Turkey (Türkiye), 07100
- Recruiting
- Antalya Egitim ve Arastırma Hastanesi
-
Diyarbakır, Turkey (Türkiye), 21200
- Recruiting
- Dicle Üniversitesi
-
İstanbul - Fatih, Turkey (Türkiye), 34098
- Recruiting
- Istanbul Universitesi Cerrahpasa
-
-
Turkey
-
Ankara, Turkey, Turkey (Türkiye), 06230
- Recruiting
- Ankara University Health Practice and Research Hospitals
-
-
İ̇stanbul
-
Istanbul, İ̇stanbul, Turkey (Türkiye), 34214
- Recruiting
- Medipol Mega Universite Hastanesi
-
Istanbul, İ̇stanbul, Turkey (Türkiye), 34295
- Recruiting
- İ.A.Ü VM Medical Park Florya Hastanesi
-
Istanbul, İ̇stanbul, Turkey (Türkiye), 34722
- Not yet recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
-
-
-
-
-
Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
-
-
Carnwall
-
Truro, Carnwall, United Kingdom, TR1 3LJ
- Recruiting
- Royal Cornwall Hospitals NHS Trust
-
-
England
-
Sheffield, England, United Kingdom, S10 2SJ
- Not yet recruiting
- Weston Park Hospital
-
-
Hillingdon
-
Northwood, Hillingdon, United Kingdom, HA6 2RN
- Not yet recruiting
- Mount Vernon Hospital
-
-
London, CITY of
-
London, London, CITY of, United Kingdom, EC1A 7BE
- Recruiting
- St Bartholomew's Hospital
-
-
Somerset
-
Taunton, Somerset, United Kingdom, TA1 5DA
- Not yet recruiting
- Musgrove Park Hospital
-
-
Suffolk
-
Ipswich, Suffolk, United Kingdom, IP4 5PD
- Not yet recruiting
- Ipswich Hospital
-
-
-
-
California
-
Fullerton, California, United States, 92835
- Recruiting
- Providence St. Jude Medical Center
-
Fullerton, California, United States, 92835
- Recruiting
- Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
-
Fullerton, California, United States, 92835
- Recruiting
- St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Recruiting
- Intermountain Health Cancer Center Lutheran Hospital
-
Grand Junction, Colorado, United States, 81501
- Recruiting
- Cancer Centers of Colorado St. Mary's Regional Hospital
-
Grand Junction, Colorado, United States, 81505
- Recruiting
- Intermountain Health
-
Grand Junction, Colorado, United States, 81501
- Recruiting
- Intermountain Health St. Mary's Regional Hospital
-
Wheat Ridge, Colorado, United States, 80401
- Recruiting
- Intermountain Health Lutheran Hospital
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20422
- Recruiting
- Washington DC Veterans Affairs Medical Center
-
-
Florida
-
Orange City, Florida, United States, 32763
- Recruiting
- Mid Florida Hematology and Oncology Center
-
Plantation, Florida, United States, 33322
- Recruiting
- BRCR Global
-
-
Illinois
-
Elmhurst, Illinois, United States, 60126
- Recruiting
- Endeavor Health
-
Hinsdale, Illinois, United States, 60521
- Recruiting
- Hope and Healing Cancer Services
-
Naperville, Illinois, United States, 60540
- Recruiting
- Endeavor Health
-
New Lenox, Illinois, United States, 60451
- Recruiting
- Hope and Healing Cancer Services
-
-
Maine
-
Portland, Maine, United States, 04102
- Recruiting
- Maine Medical Center
-
Scarborough, Maine, United States, 04074
- Recruiting
- MaineHealth Cancer Care - Scarborough
-
South Portland, Maine, United States, 04106
- Recruiting
- MaineHealth Cancer Care and IV Therapy - South Portland
-
-
Minnesota
-
Burnsville, Minnesota, United States, 55337
- Recruiting
- Minnesota Oncology Hematology, PA
-
Coon Rapids, Minnesota, United States, 55433
- Recruiting
- Minnesota Oncology Hematology PA
-
Edina, Minnesota, United States, 55435
- Recruiting
- M Health Fairview Cancer Clinic-Edina
-
Edina, Minnesota, United States, 55435
- Recruiting
- Minnesota Oncology Hematology PA
-
Maple Grove, Minnesota, United States, 55369
- Recruiting
- Minnesota Oncology Hematology PA
-
Maplewood, Minnesota, United States, 55109
- Recruiting
- M Health Fairview St. John's Hospital
-
Maplewood, Minnesota, United States, 55109
- Recruiting
- Minnesota Oncology Hematology PA
-
Minneapolis, Minnesota, United States, 55415
- Recruiting
- Hennepin County Medical Center
-
Robbinsdale, Minnesota, United States, 55422
- Recruiting
- North Memorial Health Cancer Center
-
Saint Louis Park, Minnesota, United States, 55426
- Recruiting
- Park Nicollet Frauenshuh Cancer Center
-
Saint Louis Park, Minnesota, United States, 55426
- Recruiting
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital
-
Woodbury, Minnesota, United States, 55125
- Recruiting
- Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- Recruiting
- Jackson Oncology Associates, PLLC
-
Jackson, Mississippi, United States, 39216
- Recruiting
- Jackson Oncology Associates, PLLC
-
-
Nebraska
-
Fremont, Nebraska, United States, 68025
- Recruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
-
Grand Island, Nebraska, United States, 68803
- Recruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
-
Grand Island, Nebraska, United States, 68803
- Recruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
-
Lincoln, Nebraska, United States, 68516
- Recruiting
- Cancer Partners of Nebraska - April Sampson Cancer Center
-
Omaha, Nebraska, United States, 68130
- Recruiting
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Methodist
-
Omaha, Nebraska, United States, 68124
- Recruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
-
-
New York
-
Nyack, New York, United States, 10960
- Recruiting
- Hematology Oncology Associates of Rockland
-
-
North Carolina
-
Wilson, North Carolina, United States, 27893
- Recruiting
- Carolina Cancer Research Center
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Recruiting
- Gabrail Cancer Center Research
-
-
Texas
-
Conroe, Texas, United States, 77384
- Recruiting
- The University of Texas, MD Anderson Cancer Center - Woodlands
-
El Paso, Texas, United States, 79915
- Recruiting
- Renovatio Clinical - El Paso
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Center Diagnostic Imaging
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas, MD Anderson Cancer Center- Interventional Radiology
-
Houston, Texas, United States, 77054
- Recruiting
- The University of Texas MD Anderson Cancer Center Clinical Research Imaging
-
Houston, Texas, United States, 77079
- Recruiting
- The University of Texas, MD Anderson Cancer Center - West Houston
-
Kingwood, Texas, United States, 77339
- Recruiting
- Community Clinical Trials
-
League City, Texas, United States, 77573
- Recruiting
- The University of Texas, MD Anderson Cancer Center - League City
-
Sugar Land, Texas, United States, 77478
- Recruiting
- The University of Texas, MD Anderson Cancer Center - Sugar Land
-
The Woodlands, Texas, United States, 77380
- Recruiting
- Renovatio Clinical
-
The Woodlands, Texas, United States, 77381
- Recruiting
- Woodlands Radiology
-
-
Washington
-
Olympia, Washington, United States, 98502
- Recruiting
- American Oncology Network Vista Oncology Division-West office
-
Olympia, Washington, United States, 98506
- Recruiting
- American Oncology Network Vista Oncology Division-East office
-
-
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:
Participants must meet the following criteria:
- Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).
- Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.
- Large cell neuroendocrine carcinoma is excluded.
- Candidate for treatment with pembrolizumab monotherapy per local guidelines.
- Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing
- Measurable disease based on RECIST v1.1 per investigator.
- Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.
Exclusion Criteria:
- Life expectancy of <3 months in the opinion of the investigator.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.
Participants with any of the following respiratory conditions:
- Evidence of noninfectious or drug-induced ILD or pneumonitis
- Known DLCO (adjusted for hemoglobin) <50% predicted.
- Grade ≥3 pulmonary disease unrelated to underlying malignancy
- Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter <0.5 cm are permitted.
- Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.
- Receipt of a live vaccine within 30 days prior to first dose of study intervention.
- Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.
- Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg/kg prednisone or equivalent per day) for >2 weeks, or required treatment with systemic immunosuppressive therapy.
- History of autoimmune disease that has required systemic treatment in the past 2 years
- Participants with prior solid organ or bone marrow transplantation.
- Currently receiving a high-dose steroid (>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.
Prior and concomitant therapy:
- Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
- (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.
- Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.
- Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.
- Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.
- Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
- History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.
- Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sigvotatug Vedotin with Pembrolizumab
Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
|
MMAE-Antibody Drug Conjugate targeting Integrin Beta-6
Anti-PD-(L)1
|
|
Active Comparator: Pembrolizumab Monotherapy
Participants will receive pembrolizumab, administered as an IV infusion.
|
Anti-PD-(L)1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: Baseline to date of death from any cause (Approximately 2 years)
|
Overall survival defined as the duration from enrollment to death.
|
Baseline to date of death from any cause (Approximately 2 years)
|
|
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Time Frame: From Baseline to to date of first documentation of progression OR death (Approximately 2 year)
|
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
|
From Baseline to to date of first documentation of progression OR death (Approximately 2 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival as assessed by Investigator
Time Frame: From Baseline to date of first progression or death (Approximately 4 Years)
|
Progression Free Survival (PFS) is defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurs first.
|
From Baseline to date of first progression or death (Approximately 4 Years)
|
|
Objective Response Rate as assessed by BICR
Time Frame: From Baseline to to the date of progression OR death (approximately to 4 years)
|
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
|
From Baseline to to the date of progression OR death (approximately to 4 years)
|
|
Objective Response Rate as assessed by Investigator
Time Frame: From Baseline to to the date of progression OR death (approximately to 4 years)
|
defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
|
From Baseline to to the date of progression OR death (approximately to 4 years)
|
|
Duration of Response as assessed by BICR
Time Frame: From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
|
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
|
From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
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Duration of Response as assessed by Investigator
Time Frame: From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
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defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
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From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
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Number of participants with adverse events (AEs)
Time Frame: From Baseline to end of treatment (up to 4 years)
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Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose.
Relatedness to [study drug] was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
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From Baseline to end of treatment (up to 4 years)
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Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
Time Frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
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Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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PK of ac-MMAE in plasma: Plasma predose concentration (Cpredose)
Time Frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
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Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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PK of unconjugated monomethyl auristatin E (MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
Time Frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
|
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
|
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PK of MMAE in plasma: Plasma predose concentration (Cpredose)
Time Frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
|
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab
|
Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
|
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Number of participants with antidrug antibodies (ADAs)
Time Frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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To characterize the immunogenicity of sigvotatug vedotin when administered in combination with pembrolizumab
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Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 5 Day 29, Cycle 8 Day 15 and Cycle 11 Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
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.
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)
July 23, 2025
Primary Completion (Estimated)
September 5, 2028
Study Completion (Estimated)
March 1, 2029
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
January 3, 2025
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- pembrolizumab
Other Study ID Numbers
- C5751003
- 2024-517968-36-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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