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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)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 13, 2026 → Feb 16, 2027
See other at-risk trials from Bristol-Myers Squibb

Amendment history

The 49 most recent of 64 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-23
critical
Primary completion pushed: 2026-03-13 → 2027-02-16
2025-11-18
minor
Study Status v63
Primary completion date2027-03-13→2026-03-13
Completion date2027-06-03→2027-03-15
2025-10-03
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v62
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-06-03→2027-03-13
Study sites144→122
2025-09-02
minor
Study Status, Contacts/Locations v61
Study sites144 entries, revised
OncocentroLocal Apys Országos Korányi Pulmonológiai Intézet WarmińskoInstitution - Mazurskie0096 Local CentrumInstitution Chorób- Płuc0135 Local wInstitution Olsztynie- 0196 SCLocal MemorialInstitution Healthcare- International0030 Local SRLInstitution - 0066 InstitutulLocal OncologicInstitution Bucuresti- 0031 CentrulLocal deInstitution Oncologie- "Sfântul0122 Local Nectarie"Institution - 0067 InstitutulLocal OncologicInstitution Cluj- 0062 S.C.Local CentrulInstitution de- Oncologie0063 Local EuroclinicInstitution S.R.L.- 0086 ChungbukLocal NationalInstitution University- Hospital0088 Samsung [...]
2025-08-25
minor
Study Status, Contacts/Locations v60
Study sites144 entries, revised
InstitutoLocal OncológicoInstitution de- Córdoba0093 PiusLocal HospitalInstitution Oldenburg- 0074
Show 45 earlier versions
2025-08-18
minor
Study Status, Contacts/Locations v59
Study sites144 entries, revised
NationalLocal HospitalInstitution Organization- Kyushu Cancer Center0195
2025-08-14
minor
Study Status, Contacts/Locations v58
Study sites144 entries, revised
HospitalLocal Luxemburgo Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Hospital São Lucas da PUCRS Fundação Pio XIIInstitution - Hospital0073 Local deInstitution Câncer- de0033 Local BarretosInstitution - 0034 FundaçãoLocal FaculdadeInstitution Regional- de0029 Local MedicinaInstitution de- São0037 Local JoséInstitution do- Rio0209 Local PretoInstitution - 0147 HospitalLocal SírioInstitution Libanês- 0098 HospitalLocal PaulistanoInstitution - 0108 HospitalLocal SãoInstitution Lucas- de0032 Local CopacabanaInstitution - 0114 CentroLocal deInstitution Tratamento- de0153 Lo [...] [...]
2025-07-24
minor
Study Status, Contacts/Locations v57
Study sites144 entries, revised
SUNYLocal UpstateInstitution Medical- University0127 HospitalLocal BritánicoInstitution de- Buenos0092 Local AiresInstitution - 0091 HospitalLocal ItalianoInstitution de- Buenos0106 Local AiresInstitution - 0207 CentroLocal deInstitution Educación- Médica0041 Local eInstitution Investigaciones- clínicas0168 Local "Dr.Institution Norberto- Quirno"0185 Local (CEMIC)Institution - 0169 InstitutoLocal deInstitution Oncología- Angel0180 Local H.Institution Roffo- 0194 KlinikLocal FloridsdorfInstitution - 0171 BeijingLocal CancerInstitution hospital- 0166 ArmyLocal MedicalInstitution Center- of0181 L [...] [...]
2025-05-15
minor
Study Status, Contacts/Locations v56
Study sites144 entries, revised
Fundacion Arturo Lopez Perez (FALP) HopitalCHU Charles Nicolle "Theagenio" C H U Rouen TheagenioCancer Hospital of Thessaloniki LocalAll InstitutionIndia -Institute 0218of Medical Sciences
2025-05-02
minor
Study Status, Study Design, Outcome Measures, Contacts/Locations v55
Primary completion date2029-02-26→2027-06-03
Completion date2031-01-27→2027-06-03
Enrollment target230→190
Secondary endpointsdetails revised at 9 of 12 entries
Study sites144 entries, revised
GrupoCentro de Tratamento de Tumores Botafogo para Oncoclinicas BotafogoRio de Janeiro SA
2025-03-11
minor
Study Status, Contacts/Locations v54
Study sitesdetails revised at 1 of 144 sites
2025-03-10
minor
Study Status, Contacts/Locations v53
Study sites144 entries, revised
LocalHemato InstitutionOncology - 0102Clinic
2025-02-20
minor
Study Status, Contacts/Locations v52
Study sites144 entries, revised
LocalT.C. InstitutionSaglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - 0097Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi LocalSakarya InstitutionTraining -and 0085Research Hospital
2025-02-12
minor
Study Status, Contacts/Locations v51
Study sites144 entries, revised
LocalAnkara InstitutionBilkent -Şehir 0086Hastanesi
2025-02-10
minor
Study Status, Contacts/Locations v50
Study sites144 entries, revised
LocalSbü InstitutionGülhane -Eğitim 0084Ve Araştirma Hastanesi
2025-02-06
minor
Study Status, Contacts/Locations, References v49
Study sites144 entries, revised
PrincessLocal MargaretInstitution Cancer- Centre0002 CentreLocal integreInstitution universitaire- de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec0123
2025-01-06
minor
Study Status, Contacts/Locations v48
Study sites144 entries, revised
LocalHCG InstitutionAastha -Cancer 0118Centre LocalManipal Institution - 0082Hospitals
2024-12-10
minor
Study Status, Contacts/Locations v47
Study sites144 entries, revised
LocalGrant InstitutionMedical Foundation - 0045Ruby Hall Clinic
2024-12-09
minor
Study Status, Contacts/Locations v46
Study sites144 entries, revised
LocalArtemis Institutionhospital Sahyadri -Super 0044Speciality Hospital LocalRajiv InstitutionGandhi -Cancer 0049 LocalInstitute InstitutionAnd -Research 0076Centre
2024-12-02
minor
Study Status, Contacts/Locations, References v45
Study sites144 entries, revised
LocalAmsterdam InstitutionUMC, -locatie 0216VUmc
2024-11-16
minor
Study Status, Contacts/Locations v44
Study sites144 entries, revised
LocalVM InstitutionMedical -Park 0083Pendik Hospital
2024-11-13
minor
Study Status, Contacts/Locations v43
Study sites144 entries, revised
LocalMedipol InstitutionMega -Universite 0087Hastanesi
2024-11-11
minor
Study Status, Contacts/Locations v42
Study sites144 entries, revised
LocalAdana InstitutionMedical -Park 0088Seyhan Hastanesi
2024-10-22
minor
Study Status, Contacts/Locations, References v41
Study sites144 entries, revised
LocalHospital InstitutionSírio - 0209Libanês
2024-09-25
minor
Study Status, Contacts/Locations, References v40
Study sites144 entries, revised
LocalBeth InstitutionIsrael -Deaconess 0201Medical Center
2024-08-30
minor
Study Status, Contacts/Locations v39
Study sites144 entries, revised
LocalSUNY InstitutionUpstate -Medical 0127University
2024-08-23
minor
Study Status, Contacts/Locations v38
Study sites143→144
2024-08-19
minor
Study Status, Contacts/Locations v37
Study sites142→143
2024-08-15
minor
Study Status, Contacts/Locations v36
Study sites142 entries, revised
LocalFudan InstitutionUniversity -Shanghai 0179Cancer Center LocalTokyo InstitutionMetropolitan -Komagome 0198Hospital
2024-08-13
minor
Study Status, Contacts/Locations v35
Study sites142 entries, revised
LocalMassachusetts InstitutionGeneral -Hospital Országos 0075 LocalKorányi InstitutionPulmonológiai - 0135Intézet
2024-08-06
minor
Study Status, Contacts/Locations, References v34
Study sites139→142
2024-07-29
minor
Study Status, Contacts/Locations v33
Study sites139 entries, revised
LocalPerlmutter InstitutionCancer Center at NYU Langone Hospital - 0210Long Island
2024-07-24
minor
Study Status, Contacts/Locations v32
Study sites139 entries, revised
LocalInstituto Institutionde -Oncología 0207Angel H. Roffo Sendai KouseiKosei Hospital CentrulSC medicalMemorial FocusHealthcare International SRL
2024-06-24
minor
Study Status, Contacts/Locations v31
Study sites139 entries, revised
LocalAffiliated InstitutionCancer -Hospital 0171of Harbin Medical University
2024-06-11
minor
Study Status, Contacts/Locations v30
Study sites139 entries, revised
LocalHospital InstitutionItaliano -de 0091Buenos Aires LocalCentro Institutionde -Educación 0106Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) LocalThe InstitutionFirst -Affiliated 0202Hospital of Nanchang University
2024-06-06
minor
Study Status, Contacts/Locations v29
Study sites139 entries, revised
LocalSociedade InstitutionBeneficente -Israelita 0114Brasileira Hospital Albert Einstein
2024-05-31
minor
Study Status, Contacts/Locations v28
Study sites137→139
2024-05-30
minor
Study Status, Contacts/Locations, References v27
Study sites137 entries, revised
LocalGrupo InstitutionOncoclinicas - 0108Botafogo
2024-05-28
minor
Study Status, Contacts/Locations, References v26
Study sites137 entries, revised
LocalOncocentro InstitutionApys The -First 0096 LocalAffiliated Institutionhospital -of 0169Xiamen University
2024-05-20
minor
Study Status, Contacts/Locations v25
Study sites137 entries, revised
LocalCentre InstitutionGeorges François Leclerc Cro-Irccs Hospital 0109 LocalUniversitario InstitutionPuerta -de 0151 LocalHierro Institution - 0139Majadahonda
2024-05-16
minor
Study Status, Contacts/Locations v24
Study sites136→137
2024-05-13
minor
Study Status, Contacts/Locations v23
Study sites136 entries, revised
LocalTheagenio Institution - 0156Hospital
2024-05-10
minor
Study Status, Contacts/Locations v22
Study sites136 entries, revised
LocalInstituto InstitutionAlexander Fleming FALP Warmińsko - 0090 LocalMazurskie InstitutionCentrum -Chorób 0094 LocalPłuc Institutionw - 0196Olsztynie
2024-05-08
minor
Study Status, Contacts/Locations, References v21
Study sites136 entries, revised
LocalHospital InstitutionSão -Lucas 0098de Copacabana Beijing Cancer hospital West China Hospital Local, InstitutionSichuan - 0177University
2024-05-06
minor
Study Status, Contacts/Locations, References v20
Study sites135→136
2024-05-02
minor
Study Status, Contacts/Locations v19
Study sites134→135
2024-04-15
minor
Study Status, Contacts/Locations, References v18
Study sites134 entries, revised
LocalHospital InstitutionLuxemburgo Centro -Gaucho 0073Integrado De Oncologia, Hematologia, Ensino E Pesquisa LocalArmy InstitutionMedical -Center 0033of PLA LocalUniversitaetsklinikum InstitutionCarl -Gustav 0185Carus Dresden LocalNagoya InstitutionUniversity - 0035 Local Institution - 0190Hospital
2024-04-08
minor
Study Status, Contacts/Locations v17
Study sites134 entries, revised
LocalAttikon InstitutionGeneral -University 0155Hospital
2024-04-03
minor
Study Status, Contacts/Locations, References v16
Study sites134 entries, revised
LocalHenan InstitutionCancer - 0166Hospital LocalJilin InstitutionCancer - 0178Hospital
2024-03-29
minor
Study Status, Contacts/Locations, References v15
Study sites132→134
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).
Trial Details
NCT Number NCT06140836
Lead Sponsor Bristol-Myers Squibb
Collaborators: Zai Lab (Shanghai) Co., Ltd.
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 190 participants
Start Date 2023-12-21
Primary Completion 2027-02-16 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-22