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Brief Title: A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Official Title: Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Study ID: NCT06140836
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0136, Augusta, Georgia, United States
Local Institution - 0075, Boston, Massachusetts, United States
Local Institution - 0201, Boston, Massachusetts, United States
Local Institution - 0217, Brooklyn, New York, United States
Local Institution - 0210, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Local Institution - 0127, Syracuse, New York, United States
Local Institution - 0061, Milwaukee, Wisconsin, United States
Hospital Británico de Buenos Aires, Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0091, ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0106, Buenos Aires, , Argentina
Local Institution - 0207, Buenos Aires, , Argentina
Instituto Oncológico de Córdoba, Córdoba, , Argentina
Klinik Floridsdorf, Wien, , Austria
Hospital Luxemburgo, Belo Horizonte, Minas Gerais, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
Local Institution - 0209, Sao Paulo, São Paulo, Brazil
Hospital Paulistano, Sao Paulo, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, São Paulo, Brazil
Hospital São Lucas de Copacabana, Rio de Janeiro, , Brazil
Grupo Oncoclinicas Botafogo, Rio de Janeiro, , Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
Local Institution - 0114, São Paulo, , Brazil
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec, Trois-Rivières, Quebec, Canada
FALP, Santiago, Región Metropolitana De Santiago, Chile
Oncocentro Apys, Viña del Mar, Valparaíso, Chile
Beijing Cancer hospital, Beijing, Beijing, China
Army Medical Center of PLA, Chongqing, Chongqing, China
Local Institution - 0192, Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University, Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Local Institution - 0171, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan Shi, Hubei, China
Local Institution - 0203, Wuhan, Hubei, China
Hunan Province People'S Hospital, Changsha, Hunan, China
Local Institution - 0165, Changsha, Hunan, China
Jiangsu Province Hospital Of Chinese Medicine, Nanjing, Jiangsu, China
Local Institution - 0202, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Shandong Cancer Hospital, Jinan, Shandong, China
Local Institution - 0205, Linyi, Shandong, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Local Institution - 0179, Shanghai, Shanghai, China
Local Institution - 0170, Chengdu, Sichuan, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Local Institution - 0204, Kunming, Yunnan, China
Local Institution - 0206, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Nouvel Hôpital Civil (NHC), Strasbourg, Alsace, France
CHU Bordeaux Haut-Leveque, Pessac, Aquitaine, France
Centre Georges François Leclerc, Dijon, Côte-d'Or, France
Hopital Charles Nicolle C H U Rouen, Rouen, Haute-Normandie, France
Chu Grenoble Alpes, La Tronche, Isère, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes, Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier Lyon Sud, Pierre-Bénite, Rhône, France
Hopitaux Universitaires Paris Centre-Hopital Cochin, Paris, , France
Klinikum Esslingen, Esslingen, Baden-Württemberg, Germany
Klinikum Würzburg Mitte, Wuerzburg, Bayern, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Asklepios Klinik Gauting GmbH, Gauting, , Germany
Lungenfachklinik Immenhausen, Immenhausen, , Germany
Universitaetsklinikum Koeln, Köln, , Germany
Marienhaus Klinikum Mainz, Mainz, , Germany
University Hospital of Patras, Patras, Achaḯa, Greece
Local Institution - 0153, Athens, Attikí, Greece
Attikon General University Hospital, Chaidari, Attikí, Greece
Theagenio Hospital, Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0135, Budapest, , Hungary
Local Institution - 0218, New Delhi, Delhi, India
Local Institution - 0076, New Delhi, Delhi, India
Local Institution - 0102, Ahmedabad, Gujarat, India
Local Institution - 0118, Ahmedabad, Gujarat, India
Local Institution - 0117, Gurgaon, Haryana, India
Local Institution - 0044, Gurugram, Haryana, India
Local Institution - 0082, Bengaluru, Karnataka, India
Local Institution - 0219, Thiruvananthapuram, Kerala, India
Local Institution - 0065, Mumbai, Maharashtra, India
Local Institution - 0048, Mumbai, Maharashtra, India
Local Institution - 0045, Pune, Maharashtra, India
Local Institution - 0049, Pune, Maharashtra, India
Local Institution - 0220, Hyderabad, Telangana, India
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardia, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V., Naples, Napoli, Italy
Istituto Nazionale Tumori Regina Elena, Rome, Roma, Italy
Cro-Irccs, Aviano, , Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Local Institution - 0198, Bunkyo ku, Tokyo, Japan
Tottori University Hospital, Yonago, Tottori, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Tokyo Metropolitan Police Hospital, Tokyo, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0216, Amsterdam, Noord-Holland, Netherlands
Local Institution - 0215, Groningen, , Netherlands
Instytut Genetyki i Immunologii GENIM, Lublin, Lubelskie, Poland
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie, Olsztyn, Warmińsko-mazurskie, Poland
Institutul Oncologic Bucuresti, Bucharest, București, Romania
Centrul de Oncologie "Sfântul Nectarie", Craiova, Dolj, Romania
Centrul medical Focus, București, , Romania
Institutul Oncologic Cluj, Cluj, , Romania
S.C. Centrul de Oncologie Euroclinic S.R.L., Iași, , Romania
CHUAC-Hospital Teresa Herrera, A Coruña, A Coruña [La Coruña], Spain
CHUS - Hospital Clinico Universitario, Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Comunidad De, Spain
H.R.U Málaga - Hospital General, Málaga, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Kantonspital Baden, Baden, , Switzerland
Local Institution - 0086, Yenimahalle, Ankara, Turkey
Local Institution - 0087, Stanbul, İstanbul, Turkey
Local Institution - 0088, Adana, , Turkey
Local Institution - 0084, Ankara, , Turkey
Local Institution - 0097, Istanbul, , Turkey
Local Institution - 0083, Istanbul, , Turkey
Local Institution - 0085, Sakarya, , Turkey
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR