NCT06140836Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 21 Dec 2023
- Primary completion date
- 16 Feb 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT06140836
- EU CT number
- 2023-505604-32-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 190
- From 21 Dec 2023 to the primary completion date, 16 Feb 2027
- 123 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)
- Note: Other protocol-defined inclusion/exclusion criteria apply
Other illness
- 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.
Other
- Symptomatic brain metastases or symptomatic leptomeningeal involvement.
- Known tumor targetable co-mutations or rearrangements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | ABB | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| - Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Kantonspital Baden Coordinator of this site? Confirm its status | Baden | Switzerland | Unknown status |
| Fundacion Arturo Lopez Perez (FALP) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| - Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| - Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| - Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Active, not recruiting |
| Asklepios Fachkliniken Muenchen-Gauting Coordinator of this site? Confirm its status | Gauting | Germany | Active, not recruiting |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Active, not recruiting |
| Marienhaus Kliniken GmbH Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Pius Hospital Oldenburg Coordinator of this site? Confirm its status | Oldenburg | Germany | Active, not recruiting |
| Klinikum Wuerzburg Mitte gGmbH Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Koranyi National Institute For Pulmonology Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| - Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| - Coordinator of this site? Confirm its status | Gurugram | India | Unknown status |
| - Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| - Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| - Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Tokyo Metropolitan Komagome Hospital Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Kosei Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Tokyo Metropolitan Police Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yonago | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul De Oncologie Monza S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Centrul De Oncologie-Euroclinic S.R.L. Coordinator of this site? Confirm its status | Iasi | Romania | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Yenimahalle | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.