Clinical Trial

A Phase 3 Multicenter Double-blind Randomized Study Of Taletrectinib Versus Placebo In Patients With ROS1-fusion Positive Stage IB-IIIA Non-small Cell Lung Cancer Who Have Undergone Complete Tumor Resection (TRUST-IV)

MOA: Taletrectinib (AB-106 or DS-6051b) is a ROS1 tyrosine kinase inhibitor (TKI) effective against ROS1 and acquired resistance mutations.

Key Eligibility:

• Histologically confirmed stage IB, II, or IIIA NSCLC that underwent locoregional curative surgery
  • Randomization should happen within 4-16 weeks after surgery if no adjuvant chemo was given (or 4-30 weeks if adjuvant chemo was given)
• Documented ROS1 rearrangement in primary tumor tissue or liquid-base sample (local)
• Co-mutations of EGFR or ALK fusion are excluded
• Archival tumor tissue (blocks or slides) must be provided
• Postoperative radiation therapy is excluded
  • Radiotherapy in the neoadjuvant setting is allowed and must be completed at least 4 weeks prior to randomization
• Prior adjuvant anticancer therapy for treatment of NSCLC, other than standard postoperative platinum-based chem, are excluded
  • Up to 4 cycles of adjuvant ICI is allowed (at least 12 weeks of washout needed before randomization)
  • Neoadjuvant chemo +/- prior ICI is allowed