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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 29 → 33 locationsv9
  2. Minor Site contacts updated at 4 of 29 sitesv8
  3. Minor Trial sites expanded: 12 → 29 locationsv7
  4. Minor Study sites: 10 to 12v6
  5. Minor Study sites: 8 to 10v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Study sites: 3 to 8v4
  2. Minor Site details revised at 1 of 3 sitesv3
  3. Minor Site details revised at 1 of 3 sitesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07154706
Lead Sponsor Nuvation Bio Inc.
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov