Clinical Trial

A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

Study acronym: REZILIENT4
Active, Not Recruiting Phase 3
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Summary
The purpose of this study is to compare the efficacy of zipalertinib combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-24
notable Trial sites expanded: 214 -> 253 locations 2026-04-07
Trial Details
NCT Number NCT07128199
Lead Sponsor Taiho Oncology, Inc.
Conditions NSCLC, Stage IB-IIIA, Lung Cancer, Adjuvant, Post-surgical, EGFR, Exon 20, Early Stage Lung Cancer, Uncommon EGFR Mutations
Enrollment 360 participants
Start Date 2025-12-22
Primary Completion 2029-10-01 (estimated)
Study Completion 2032-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-26