Repotrectinib Phase 3 Trial in ROS1+ NSCLC Reaches Primary Completion

The Phase 3 TRIDENT-3 trial for Repotrectinib (Augtyro) in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC) reached its primary completion on 2026-03-13. This study, which enrolled 190 participants, compares repotrectinib against crizotinib.

Background

Non-small cell lung cancer (NSCLC) is a common and aggressive form of lung cancer. A subset of NSCLC patients harbor rearrangements in the ROS1 gene, making them candidates for targeted therapies. Repotrectinib is being investigated as a potential treatment option for these patients, particularly those who are tyrosine kinase inhibitor (TKI)-naïve. The TRIDENT-3 trial aims to evaluate its efficacy and safety in comparison to crizotinib, an established TKI used in ROS1-positive NSCLC.

Trial design

The TRIDENT-3 study (NCT06140836) is a Phase 3 trial designed to evaluate repotrectinib against crizotinib. It enrolled 190 participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer. The primary objective is to assess the efficacy and safety of repotrectinib compared to crizotinib in this patient population. Specific primary outcome measures were not detailed in the available completion data.

What this means

The primary completion of the TRIDENT-3 trial marks a significant milestone in the development of repotrectinib for ROS1-positive NSCLC. While specific efficacy and safety results are not yet available, the completion of this Phase 3 study indicates that all planned primary data collection has concluded. The trial's findings, once released, will be crucial for understanding repotrectinib's potential role as a first-line treatment for TKI-naïve patients with this specific type of lung cancer, especially in comparison to the current standard of care, crizotinib.

Source

Information regarding the primary completion of the TRIDENT-3 trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06140836, titled "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)," was posted on 2026-03-13 on clinicaltrials.gov.