Phase 3 Taletrectinib for ROS1-Positive NSCLC
This study is testing a drug called taletrectinib to see if it can help prevent non-small cell lung cancer (NSCLC) from returning after surgery. You might be able to join if you have early-stage NSCLC (stages IB, II, or IIIA) and your tumor has a specific genetic change called a ROS1 rearrangement. Researchers will compare taletrectinib to a placebo (a sugar pill) to see if taletrectinib is better at keeping the cancer away. The study aims to enroll 180 participants.
- Study design
- This is a Phase 3, multicenter, double-blind, randomized study. It will compare taletrectinib with a placebo in about 180 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to approximately 5 years after the first person joins the study, with a maximum follow-up of 70 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
At a glance
Conditions
Where it's being run
33 sites across 26 statesWho to contact
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What this trial measures
- Primary Outcome Measure: To compare the efficacy of taletrectinib with that of placebo, as measured by disease-free survival (DFS) by investigator assessment.Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence) by investigator's assessment.