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

The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.

Trial Details

NCT ID
NCT07154706
Phase
PHASE3
Sponsor
Nuvation Bio Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Taletrectinib
  • Placebo
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Orlando, Florida, United States|28.53834,-81.37924
  • Boise, Idaho, United States|43.6135,-116.20345

Key Eligibility Criteria

  • Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging.
  • Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories.
  • Adequate tissue is available for prospective central laboratory confirmatory testing. Confirmation of central test positivity is required prior to …
  • Note: In the event that the local testing assay is the same as the central testing assay, and the local test was conducted in a CLIA-certified labo…

For full eligibility, visit ClinicalTrials.gov.

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