Randomized Open-label Multicenter Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-na ve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Brief description of study

This is a study to compare two medicines (repotrectinib and crizotinib) for patients with a type of lung cancer called ROS1-positive NSCLC (Non-small Cell Lung Cancer). The study team wants to see which treatment works better for patients whose cancer hasn't been treated before with targeted treatment. Some patients with specific types of spread of cancer (NS metastases or leptomeningeal disease) in their brain can join too. Patients who fit the rules will be put into two groups randomly. One group will get repotrectinib (Arm A), and the other will get crizotinib (Arm B). The patients will take these medicines by mouth. The study has three parts: first checking if people can join, then getting the treatment, and finally keeping an eye on them to make sure there are few side effects and how they're doing after the treatment stops.


Clinical Study Identifier: s23-01178
ClinicalTrials.gov Identifier: NCT06140836
Principal Investigator: Vamsidhar Velcheti.
Other Investigators: Joshua K Sabari, Samantha VanMaanen, Elka R Travis, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Sally Lau, Danny Perlaza, Marissa Rybstein, David Mendoza, Natalia Cherkassky, James Newman, Jeffrey G Schneider, Melissa L Martinez, Kirby Rodriguez.


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