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.

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NCT07154706

Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Nuvation Bio Inc.
~180 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:TaletrectinibPlacebo

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure: To compare the efficacy of taletrectinib with that of placebo, as measured by disease-free survival (DFS) by investigator assessment.
Measured over Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Non-small Cell Lung Cancer (NSCLC)
33 sites across 26 states
Shanghai Municipality3
California2
Texas2
Beijing Municipality2
Jiangsu2
Shandong2
District of Columbia1
Florida1

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  • 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.