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)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT06140836
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
- 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
- Symptomatic brain metastases or symptomatic leptomeningeal involvement.
- 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)
Note: Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Crizotinib - Arm A Repotrectinib -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to approximately 41 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 41 months Overall Response Rate (ORR) as per BICR according to RECIST v1.1 Up to approximately 41 months ORR as per Investigator according to RECIST v1.1 Up to approximately 41 months Duration of Response (DOR) as per BICR according to RECIST v1.1 Up to approximately 41 months DOR as per Investigator according to RECIST v1.1 Up to approximately 41 months Time to Response (TTR) as per BICR according to RECIST v1.1 Up to approximately 41 months TTR as per Investigator according to RECIST v1.1 Up to approximately 41 months PFS as per Investigator according to RECIST v1.1 Up to approximately 41 months Time to intracranial progressions as per BICR according to RECIST v1.1 Up to approximately 41 months Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs Up to 30 days after last dose Number of deaths Up to 30 days after last dose Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score Up to 30 days after last dose
Trial Locations
- Locations (144)
Local Institution - 0136
🇺🇸Augusta, Georgia, United States
Local Institution - 0221
🇺🇸Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Local Institution - 0217
🇺🇸Brooklyn, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Local Institution - 0214
🇺🇸Tacoma, Washington, 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
Hospital Italiano de Buenos Aires
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
🇦🇷Buenos Aires, Argentina
Instituto de Oncología Angel H. Roffo
🇦🇷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
Hospital Sírio Libanês
🇧🇷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
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
🇧🇷Rio de Janeiro, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
🇧🇷São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
🇧🇷São Paulo, Brazil
Local Institution - 0002
🇨🇦Toronto, Ontario, Canada
Local Institution - 0123
🇨🇦Trois-Rivières, Quebec, Canada
Fundacion Arturo Lopez Perez (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
Affiliated Cancer Hospital of Harbin Medical University
🇨🇳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
The First Affiliated Hospital of Nanchang University
🇨🇳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
Fudan University Shanghai Cancer Center
🇨🇳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
CHU Charles Nicolle
🇫🇷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
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, 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
Thoracic General Hospital of Athens "I Sotiria"
🇬🇷Athens, Attikí, Greece
Attikon General University Hospital
🇬🇷Chaidari, Attikí, Greece
"Theagenio" Cancer Hospital of Thessaloniki
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
Országos Korányi Pulmonológiai Intézet
🇭🇺Budapest, Hungary
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳New Delhi, Delhi, India
Hemato Oncology Clinic
🇮🇳Ahmedabad, Gujarat, India
HCG Aastha Cancer Centre
🇮🇳Ahmedabad, Gujarat, India
Local Institution - 0117
🇮🇳Gurgaon, Haryana, India
Artemis hospital
🇮🇳Gurugram, Haryana, India
Manipal Hospitals
🇮🇳Bengaluru, Karnataka, India
Local Institution - 0219
🇮🇳Thiruvananthapuram, Kerala, India
Local Institution - 0065
🇮🇳Mumbai, Maharashtra, India
Local Institution - 0048
🇮🇳Mumbai, Maharashtra, India
Grant Medical Foundation - Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Local Institution - 0220
🇮🇳Hyderabad, Telangana, India
Cro-Irccs
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
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
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 Kosei Hospital
🇯🇵Sendai, Miyagi, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵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 - 0223
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0237
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0222
🇲🇾Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0226
🇲🇾Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0224
🇲🇾Putrajaya, Wilayah Persekutuan Kuala Lumpur, Malaysia
Amsterdam UMC, locatie VUmc
🇳🇱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
SC Memorial Healthcare International SRL
🇷🇴Bucharest, București, Romania
Institutul Oncologic Bucuresti
🇷🇴Bucharest, București, Romania
Centrul de Oncologie "Sfântul Nectarie"
🇷🇴Craiova, Dolj, 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, Aargau, Switzerland
Ankara Bilkent Şehir Hastanesi
🇹🇷Yenimahalle, Ankara, Turkey
Adana Medical Park Seyhan Hastanesi
🇹🇷Adana, Turkey
Sbü Gülhane Eğitim Ve Araştirma Hastanesi
🇹🇷Ankara, Turkey
Medipol Mega Universite Hastanesi
🇹🇷Istanbul, Turkey
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
VM Medical Park Pendik Hospital
🇹🇷Istanbul, Turkey
Sakarya Training and Research Hospital
🇹🇷Sakarya, Turkey