2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.88 (Poster) REZILIENT3: Phase 3 Study of Zipalertinib Plus Chemotherapy in Previously Untreated, Advanced, Nonsquamous NSCLC Patients With EGFR Exon 20 Insertions

PP01.88 (Poster) REZILIENT3: Phase 3 Study of Zipalertinib Plus Chemotherapy in Previously Untreated, Advanced, Nonsquamous NSCLC Patients With EGFR Exon 20 Insertions

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Pdf Summary

REZILIENT3 is a phase 3 study designed to evaluate the efficacy and safety of zipalertinib, an oral EGFR tyrosine kinase inhibitor (TKI), in combination with standard chemotherapy in patients with previously untreated, advanced, nonsquamous NSCLC harboring EGFR exon 20 insertions (ex20ins) mutations.<br /><br />The study has two parts: a safety lead-in (Part A) and a randomized phase 3 (Part B). Part A aims to determine the recommended dose of zipalertinib in combination with chemotherapy, while Part B will compare the efficacy and safety of zipalertinib plus chemotherapy versus chemotherapy alone. <br /><br />In Part A, approximately 6-12 patients will be enrolled using a rolling-6 design to confirm the recommended dose. In Part B, approximately 300 patients will be randomized in a 1:1 ratio. The primary endpoint for both parts is progression-free survival (PFS) assessed by blinded independent central review. Secondary endpoints include overall survival, objective response rate, disease control rate, duration of response, safety, pharmacokinetics, patient-reported outcomes, and biomarkers.<br /><br />Patient eligibility criteria include age 18 years or older, locally advanced or metastatic nonsquamous NSCLC, no prior systemic treatment for advanced or metastatic disease, documented EGFR mutation status (ex20ins or other common EGFR mutations), measurable lesion per RECIST v1.1, ECOG performance status of 0 or 1, and adequate organ function.<br /><br />The study is sponsored by Taiho Oncology, Inc. and is expected to be completed in May 2026. Zipalertinib has shown encouraging antitumor activity in previous studies and has been granted Breakthrough Therapy designation by the FDA for the treatment of NSCLC with EGFR ex20ins mutations.<br /><br />This summary provides an overview of the study design, eligibility criteria, and key endpoints of the REZILIENT3 study evaluating the efficacy and safety of zipalertinib in combination with chemotherapy in patients with EGFR ex20ins-mutant NSCLC.

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John Heymach

Keywords

REZILIENT3

zipalertinib

EGFR tyrosine kinase inhibitor

chemotherapy

nonsquamous NSCLC

EGFR exon 20 insertions

progression-free survival

patient eligibility criteria

Breakthrough Therapy designation

NSCLC