Last updated 10 days ago
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)
230 patients around the world
Available in Chile, Brazil, Argentina, United States
Bristol-Myers Squibb
17Research sites
230Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLCParticipant 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 NSCLCUp to 1 prior line of systemic treatment for NSCLC is permittedECOG 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 rearrangementsClinically significant cardiovascular disease (either active or within 6 months prior to enrollment)
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
StudyTRIDENT-3
SponsorBristol-Myers Squibb
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06140836
