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A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC

Trial Profile

A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Taletrectinib (Primary)
  • Indications Brain metastases; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TRUST; TRUST-I
  • Sponsors AnHeart Therapeutics

Most Recent Events

  • 11 Jun 2025 According to a Nuvation Bio media release, company announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The FDA approval of IBTROZI is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies.
  • 21 May 2025 According to a Nuvation Bio media release, additional results from TRUST-I and TRUST-II, its pivotal Phase 2 clinical studies on the efficacy and safety of taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place Saturday, May 31, 2025, 1:30-4:30 p.m. CT in Chicago, Illinois.
  • 22 Apr 2025 According to a Nuvation Bio media release, U.S. Food and Drug Administration assigned taletrectinib's New Drug Application with a Prescription Drug User Fee Act goal date of June 23, 2025.

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