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)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Expanded Access
Expanded Access
Available
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Contacts and Locations
Study Contact
Study Contact
- Name: First line of the email MUST contain the NCT# and Site #.
Study Contact Backup
- Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Locations
-
-
-
Buenos Aires, Argentina, C1417DTB
- Local Institution - 0207
-
Buenos Aires, Argentina, 1431
- Local Institution - 0106
-
Córdoba, Argentina, 5000
- Local Institution - 0093
-
-
Buenos Aires
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
- Local Institution - 0092
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Instituto Alexander Fleming
-
-
Buenos Aires F.D.
-
ABB, Buenos Aires F.D., Argentina, C1199ABB
- Local Institution - 0091
-
-
-
-
-
Vienna, Austria, 1210
- Local Institution - 0041
-
-
-
-
-
Rio de Janeiro, Brazil, 22061-080
- Local Institution - 0098
-
Rio de Janeiro, Brazil, 22250-905
- Local Institution - 0108
-
São Paulo, Brazil, 01401-002
- Local Institution - 0032
-
São Paulo, Brazil, 05652-900
- Local Institution - 0114
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30380-490
- Local Institution - 0073
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
- Local Institution - 0033
-
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Local Institution - 0034
-
-
São Paulo
-
Barretos, São Paulo, Brazil, 14784400
- Local Institution - 0029
-
São José do Rio Preto, São Paulo, Brazil, 15090000
- Local Institution - 0037
-
São Paulo, São Paulo, Brazil, 01308-060
- Local Institution - 0209
-
São Paulo, São Paulo, Brazil, 01321-001
- Local Institution - 0147
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Local Institution - 0002
-
-
Quebec
-
Trois-Rivières, Quebec, Canada, G8Z 3R9
- Local Institution - 0123
-
-
-
-
Región de Valparaíso
-
Viña del Mar, Región de Valparaíso, Chile, 2520598
- Local Institution - 0096
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile, 7500921
- Fundacion Arturo Lopez Perez (FALP)
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100142
- Local Institution - 0168
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 400042
- Local Institution - 0185
-
-
Fujian
-
Xiamen, Fujian, China, 361003
- Local Institution - 0169
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Local Institution - 0180
-
-
Guangxi
-
Nanning, Guangxi, China, 530000
- Local Institution - 0194
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150000
- Local Institution - 0171
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Local Institution - 0166
-
-
Hubei
-
Wuhan, Hubei, China, 430079
- Local Institution - 0181
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Local Institution - 0184
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Local Institution - 0193
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Local Institution - 0202
-
-
Jilin
-
Changchun, Jilin, China, 130012
- Local Institution - 0178
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Local Institution - 0183
-
-
Shandong
-
Jinan, Shandong, China, 250000
- Local Institution - 0186
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200030
- Local Institution - 0164
-
Shanghai, Shanghai Municipality, China, 200032
- Local Institution - 0179
-
-
Sichuan
-
Chengdu, Sichuan, China, 610044
- Local Institution - 0177
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Local Institution - 0175
-
-
-
-
-
Paris, France, 75014
- Local Institution - 0056
-
-
Alsace
-
Strasbourg, Alsace, France, 67091
- Local Institution - 0059
-
-
Aquitaine
-
Pessac, Aquitaine, France, 33600
- Local Institution - 0055
-
-
Côte-d'Or
-
Dijon, Côte-d'Or, France, 21079
- Local Institution - 0109
-
-
Haute-Normandie
-
Rouen, Haute-Normandie, France, 76031
- Local Institution - 0057
-
-
Isère
-
La Tronche, Isère, France, 38700
- Local Institution - 0058
-
-
Loire-Atlantique
-
Saint-Herblain, Loire-Atlantique, France, 44800
- Local Institution - 0189
-
-
Rhône
-
Pierre-Bénite, Rhône, France, 69310
- Local Institution - 0060
-
-
-
-
-
Berlin, Germany, 13125
- Evangelische Lungenklinik Berlin
-
Cologne, Germany, 50937
- Universitaetsklinikum Koeln
-
Dresden, Germany, 01307
- Local Institution - 0035
-
Gauting, Germany, 82131
- Asklepios Klinik Gauting GmbH
-
Immenhausen, Germany, 34376
- Lungenfachklinik Immenhausen
-
Mainz, Germany, 55131
- Marienhaus Klinikum Mainz
-
-
Baden-Wurttemberg
-
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
- Klinikum Esslingen
-
-
Bavaria
-
Würzburg, Bavaria, Germany, 97074
- Klinikum Würzburg Mitte
-
-
Lower Saxony
-
Oldenburg, Lower Saxony, Germany, 26121
- Local Institution - 0074
-
-
-
-
Achaḯa
-
Pátrai, Achaḯa, Greece, 26504
- Local Institution - 0154
-
-
Attikí
-
Athens, Attikí, Greece, 115 27
- Local Institution - 0153
-
Chaïdári, Attikí, Greece, 124 62
- Local Institution - 0155
-
-
Kentrikí Makedonía
-
Thessaloniki, Kentrikí Makedonía, Greece, 540 07
- "Theagenio" Cancer Hospital of Thessaloniki
-
-
-
-
-
Budapest, Hungary, 1121
- Local Institution - 0135
-
-
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380054
- Local Institution - 0102
-
Ahmedabad, Gujarat, India, 380060
- Local Institution - 0118
-
-
Haryana
-
Gurugram, Haryana, India, 122001
- Local Institution - 0044
-
-
Karnataka
-
Bengaluru, Karnataka, India, 560017
- Local Institution - 0082
-
-
Maharashtra
-
Pune, Maharashtra, India, 411001
- Local Institution - 0045
-
Pune, Maharashtra, India, 411004
- Local Institution - 0049
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110029
- Local Institution - 0218
-
New Delhi, National Capital Territory of Delhi, India, 110085
- Local Institution - 0076
-
-
-
-
Friuli Venezia Giulia
-
Aviano, Friuli Venezia Giulia, Italy, 33081
- Local Institution - 0151
-
-
Lombardy
-
Milan, Lombardy, Italy, 20133
- Local Institution - 0152
-
Monza, Lombardy, Italy, 20900
- Local Institution - 0149
-
-
Napoli
-
Naples, Napoli, Italy, 80131
- Local Institution - 0150
-
-
Roma
-
Rome, Roma, Italy, 00144
- Local Institution - 0148
-
-
-
-
-
Fukuoka, Japan, 811-1395
- Local Institution - 0195
-
Osaka, Japan, 534-0021
- Local Institution - 0160
-
Osaka, Japan, 541-8567
- Local Institution - 0167
-
Tokyo, Japan, 164-8541
- Tokyo Metropolitan Police Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Local Institution - 0190
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- Local Institution - 0132
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-0280
- Local Institution - 0174
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Local Institution - 0163
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 2418515
- Local Institution - 0173
-
-
Miyagi
-
Sendai, Miyagi, Japan, 9800873
- Sendai Kosei Hospital
-
-
Tokyo
-
Bunkyo Ku, Tokyo, Japan, 113-8677
- Tokyo Metropolitan Komagome Hospital
-
-
Tottori
-
Yonago, Tottori, Japan, 683-8504
- Local Institution - 0159
-
-
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1081 HV
- Local Institution - 0216
-
-
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Poland, 20-609
- Local Institution - 0187
-
-
Warmian-Masurian Voivodeship
-
Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
- Local Institution - 0196
-
-
-
-
-
Cluj-Napoca, Romania, 400015
- Local Institution - 0122
-
Iași, Romania, 700106
- Local Institution - 0067
-
-
București
-
Bucharest, București, Romania, 022328
- Local Institution - 0066
-
Bucharest, București, Romania, 013812
- Local Institution - 0030
-
-
Dolj
-
Craiova, Dolj, Romania, 200746
- Local Institution - 0031
-
-
-
-
Chungcheongbuk-do [Chungbuk]
-
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea, 28644
- Local Institution - 0062
-
-
Kyǒnggi-do
-
Seongnam, Kyǒnggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
-
-
Seoul-teukbyeolsi [Seoul]
-
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
- Asan Medical Center
-
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
- Local Institution - 0063
-
-
-
-
-
Málaga, Spain, 29011
- Local Institution - 0142
-
Seville, Spain, 41013
- Local Institution - 0144
-
Valencia, Spain, 46026
- Local Institution - 0143
-
-
A Coruña [La Coruña]
-
A Coruña, A Coruña [La Coruña], Spain, 15006
- Local Institution - 0141
-
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
- Local Institution - 0138
-
-
Barcelona [Barcelona]
-
Barcelona, Barcelona [Barcelona], Spain, 08035
- Local Institution - 0140
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spain, 28041
- Local Institution - 0137
-
Majadahonda, Madrid, Comunidad de, Spain, 28222
- Local Institution - 0139
-
-
-
-
Canton of Aargau
-
Baden, Canton of Aargau, Switzerland, 5404
- Kantonspital Baden
-
-
-
-
-
Adana, Turkey (Türkiye), 01140
- Local Institution - 0088
-
Ankara, Turkey (Türkiye), 06010
- Local Institution - 0084
-
Istanbul, Turkey (Türkiye), 34214
- Local Institution - 0087
-
Istanbul, Turkey (Türkiye), 34440
- T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
-
Istanbul, Turkey (Türkiye), 34899
- Local Institution - 0083
-
Sakarya, Turkey (Türkiye)
- Local Institution - 0085
-
-
Ankara
-
Yenimahalle, Ankara, Turkey (Türkiye), 06200
- Local Institution - 0086
-
-
-
-
Iowa
-
Des Moines, Iowa, United States, 50309
- Local Institution - 0221
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Local Institution - 0075
-
Boston, Massachusetts, United States, 02215
- Local Institution - 0201
-
-
New York
-
Mineola, New York, United States, 11501
- Local Institution - 0210
-
New York, New York, United States, 10016
- Local Institution - 0134
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Local Institution - 0214
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Arm A
|
Specified dose on specified days
Other Names:
|
|
Active Comparator: Arm B
|
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs
Time Frame: Up to 30 days after last dose
|
Up to 30 days after last dose
|
|
Number of deaths
Time Frame: Up to 30 days after last dose
|
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
Time Frame: Up to 30 days after last dose
|
Up to 30 days after last dose
|
|
Overall Survival (OS)
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
Overall Response Rate (ORR) as per BICR according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
ORR as per Investigator according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
Duration of Response (DOR) as per BICR according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
DOR as per Investigator according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
Time to Response (TTR) as per BICR according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
TTR as per Investigator according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
PFS as per Investigator according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
|
Time to intracranial progressions as per BICR according to RECIST v1.1
Time Frame: Up to approximately 41 months
|
Up to approximately 41 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Pyridines
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Piperidines
- Aminopyridines
- Crizotinib
- repotrectinib
Other Study ID Numbers
Other Study ID Numbers
- CA127-1030
- U1111-1292-0487 (Registry Identifier: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.