NCT06140836

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)

Name: Clinical Trial NCT06140836
Creator: Bristol-Myers Squibb
Keywords: Carcinoma, Non-Small-Cell Lung, Repotrectinib, Phase 3, drug, clinical trial, Argentina,Brazil,Canada,Chile,China,Germany,Hungary,Italy,Japan,Romania,Turkey,United States of Amer

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)

Bristol-Myers Squibb·Phase 3·ClinicalTrials.gov·drugNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Carcinoma, Non-Small-Cell Lung
Drug/Device/Intervention: Repotrectinib
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Bristol-Myers Squibb
Location: Augusta,New York,New York,Buenos Aires,São José do Rio Preto,São Paulo,Montréal,Santiago,Santiago,Zhengzhou,Wuhan,Nanchang,Jinan,Linyi,Kunming,Hangzhou,Köln,Mainz,Budapest,Aviano,Nagoya,Kashiwa,Matsuy, Argentina,Brazil,Canada,Chile,China,Germany,Hungary,Italy,Japan,Romania,Turkey,United States of Amer

Timeline & enrollment

Phase: Phase 3
Start date: Jan 15, 2024
End date: Jan 27, 2031
Enrollment: 230 participants

Primary outcome

Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

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).

ICD-10 classifications

Carcinoma in situ: Bronchus and lungSecondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06140836
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06140836 through Pure Global AI's free database. This Phase 3 trial is sponsored by Bristol-Myers Squibb and is currently Not yet recruiting. The study focuses on Carcinoma, Non-Small-Cell Lung. Target enrollment is 230 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.