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)
NCT ID: NCT06140836
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2023-12-21
2027-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Repotrectinib
Specified dose on specified days
Arm B
Crizotinib
Specified dose on specified days
Interventions
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Repotrectinib
Specified dose on specified days
Crizotinib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
* At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
* Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
* Up to 1 prior line of systemic treatment for NSCLC is permitted
* ECOG Performance Status ≤ 2
Exclusion Criteria
* History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.
* Known tumor targetable co-mutations or rearrangements
* Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)
18 Years
ALL
No
Sponsors
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Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0221
Des Moines, Iowa, United States
Local Institution - 0075
Boston, Massachusetts, United States
Local Institution - 0201
Boston, Massachusetts, United States
Local Institution - 0210
Mineola, New York, United States
Local Institution - 0134
New York, New York, United States
Local Institution - 0214
Tacoma, Washington, United States
Local Institution - 0092
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0091
ABB, Buenos Aires F.D., Argentina
Local Institution - 0106
Buenos Aires, , Argentina
Local Institution - 0207
Buenos Aires, , Argentina
Local Institution - 0093
Córdoba, , Argentina
Local Institution - 0041
Vienna, , Austria
Local Institution - 0073
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0033
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0034
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0029
Barretos, São Paulo, Brazil
Local Institution - 0037
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0209
São Paulo, São Paulo, Brazil
Local Institution - 0147
São Paulo, São Paulo, Brazil
Local Institution - 0098
Rio de Janeiro, , Brazil
Local Institution - 0108
Rio de Janeiro, , Brazil
Local Institution - 0032
São Paulo, , Brazil
Local Institution - 0114
São Paulo, , Brazil
Local Institution - 0002
Toronto, Ontario, Canada
Local Institution - 0123
Trois-Rivières, Quebec, Canada
Local Institution - 0096
Viña del Mar, Región de Valparaíso, Chile
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan, Chile
Local Institution - 0168
Beijing, Beijing Municipality, China
Local Institution - 0185
Chongqing, Chongqing Municipality, China
Local Institution - 0169
Xiamen, Fujian, China
Local Institution - 0180
Guangzhou, Guangdong, China
Local Institution - 0194
Nanning, Guangxi, China
Local Institution - 0171
Harbin, Heilongjiang, China
Local Institution - 0166
Zhengzhou, Henan, China
Local Institution - 0181
Wuhan, Hubei, China
Local Institution - 0184
Changsha, Hunan, China
Local Institution - 0193
Nanjing, Jiangsu, China
Local Institution - 0202
Nanchang, Jiangxi, China
Local Institution - 0178
Changchun, Jilin, China
Local Institution - 0183
Xi'an, Shaanxi, China
Local Institution - 0186
Jinan, Shandong, China
Local Institution - 0164
Shanghai, Shanghai Municipality, China
Local Institution - 0179
Shanghai, Shanghai Municipality, China
Local Institution - 0177
Chengdu, Sichuan, China
Local Institution - 0175
Hangzhou, Zhejiang, China
Local Institution - 0059
Strasbourg, Alsace, France
Local Institution - 0055
Pessac, Aquitaine, France
Local Institution - 0109
Dijon, Côte-d'Or, France
Local Institution - 0057
Rouen, Haute-Normandie, France
Local Institution - 0058
La Tronche, Isère, France
Local Institution - 0189
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0060
Pierre-Bénite, Rhône, France
Local Institution - 0056
Paris, , France
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany
Klinikum Würzburg Mitte
Würzburg, Bavaria, Germany
Local Institution - 0074
Oldenburg, Lower Saxony, Germany
Evangelische Lungenklinik Berlin
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Local Institution - 0035
Dresden, , Germany
Asklepios Klinik Gauting GmbH
Gauting, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Marienhaus Klinikum Mainz
Mainz, , Germany
Local Institution - 0154
Pátrai, Achaḯa, Greece
Local Institution - 0153
Athens, Attikí, Greece
Local Institution - 0155
Chaïdári, Attikí, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0135
Budapest, , Hungary
Local Institution - 0102
Ahmedabad, Gujarat, India
Local Institution - 0118
Ahmedabad, Gujarat, India
Local Institution - 0044
Gurugram, Haryana, India
Local Institution - 0082
Bengaluru, Karnataka, India
Local Institution - 0045
Pune, Maharashtra, India
Local Institution - 0049
Pune, Maharashtra, India
Local Institution - 0218
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0076
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0151
Aviano, Friuli Venezia Giulia, Italy
Local Institution - 0152
Milan, Lombardy, Italy
Local Institution - 0149
Monza, Lombardy, Italy
Local Institution - 0150
Naples, Napoli, Italy
Local Institution - 0148
Rome, Roma, Italy
Local Institution - 0190
Nagoya, Aichi-ken, Japan
Local Institution - 0132
Kashiwa, Chiba, Japan
Local Institution - 0174
Matsuyama, Ehime, Japan
Local Institution - 0163
Sapporo, Hokkaido, Japan
Local Institution - 0173
Yokohama, Kanagawa, Japan
Sendai Kosei Hospital
Sendai, Miyagi, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo Ku, Tokyo, Japan
Local Institution - 0159
Yonago, Tottori, Japan
Local Institution - 0195
Fukuoka, , Japan
Local Institution - 0160
Osaka, , Japan
Local Institution - 0167
Osaka, , Japan
Tokyo Metropolitan Police Hospital
Tokyo, , Japan
Local Institution - 0216
Amsterdam, North Holland, Netherlands
Local Institution - 0187
Lublin, Lublin Voivodeship, Poland
Local Institution - 0196
Olsztyn, Warmian-Masurian Voivodeship, Poland
Local Institution - 0030
Bucharest, București, Romania
Local Institution - 0066
Bucharest, București, Romania
Local Institution - 0031
Craiova, Dolj, Romania
Local Institution - 0122
Cluj-Napoca, , Romania
Local Institution - 0067
Iași, , Romania
Local Institution - 0062
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0063
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0141
A Coruña, A Coruña [La Coruña], Spain
Local Institution - 0138
Santiago de Compostela, A Coruña [La Coruña], Spain
Local Institution - 0140
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0137
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0139
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0142
Málaga, , Spain
Local Institution - 0144
Seville, , Spain
Local Institution - 0143
Valencia, , Spain
Kantonspital Baden
Baden, Canton of Aargau, Switzerland
Local Institution - 0086
Yenimahalle, Ankara, Turkey (Türkiye)
Local Institution - 0088
Adana, , Turkey (Türkiye)
Local Institution - 0084
Ankara, , Turkey (Türkiye)
Local Institution - 0087
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Local Institution - 0083
Istanbul, , Turkey (Türkiye)
Local Institution - 0085
Sakarya, , Turkey (Türkiye)
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1292-0487
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA127-1030
Identifier Type: -
Identifier Source: org_study_id
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