Clinical Trial

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

Study acronym: REZILIENT2
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2023-07-21; most recent amendment 2026-06-25.
Status change: Active, Not Recruiting → Recruiting 2025-03-07
Status change: Recruiting → Active, Not Recruiting 2024-11-29
Trial Details
NCT Number NCT05967689
Lead Sponsor Taiho Oncology, Inc.
Conditions Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Enrollment 220 participants
Start Date 2023-07-31
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-26