Zipalertinib
Sponsors
Taiho Oncology Inc., Jonsson Comprehensive Cancer Center, Taiho Oncology, Inc., Stanford University
Conditions
EGFRLocally Advanced or Metastatic Non-Small Cell Lung CancerLung Cancer (NSCLC)Lung Non-Squamous Non-Small Cell CarcinomaNon Small Cell Lung CancerNon-Small Cell Lung CancerNon-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion MutationsStage IB-IIIA NSCLC Patients with uncommon EGFR Mutations
Phase 2
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
RecruitingCTIS2023-503865-48-00
Start: 2024-02-16Target: 117Updated: 2026-01-16
Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
Not yet recruitingNCT07229339
Start: 2027-06-01End: 2030-06-01Target: 16Updated: 2026-02-05
Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC
Not yet recruitingNCT07802834
Start: 2026-11-01End: 2028-12-01Target: 42Updated: 2026-09-03
Phase 3
Randomized, Controlled, Open-label, Phase 3, Global Multi-Center Trial to Assess the Efficacy and Safety of Zipalertinib plus Chemotherapy versus Chemotherapy alone, in Patients with Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Active, not recruitingCTIS2023-503575-21-00
Start: 2024-01-23Target: 118Updated: 2025-11-04
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
RecruitingCTIS2025-521775-31-00
Start: 2025-11-12Target: 126Updated: 2026-01-12