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An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

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Trial Profile

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Jul 2025

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At a glance

  • Drugs Zipalertinib (Primary)
  • Indications Brain metastases; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms REZILIENT2
  • Sponsors Taiho Oncology

Most Recent Events

  • 09 Jul 2025 According to a Taiho oncology media release, The National Comprehensive Cancer Network Oncology Research Program awards funding to researchers from UCLA Health Jonsson Comprehensive Cancer Center for the project- "Phase 2 Trial of Zipalertinib in Patients with Resectable Non-small cell lung cancer with EGFR Exon 20 Insertion or Uncommon/Compound Mutations", to be completed in 2 years.
  • 03 Jun 2025 Planned number of patients changed from 160 to 220.
  • 12 Mar 2025 Planned End Date changed from 20 Oct 2025 to 28 Aug 2026.

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