Taiho Oncology, Inc.
The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) versus placebo in participants with resected early stage NSCLC harboring uncommon EGFRmt. Approximately 360 participants will be randomized to: Arm A: Zipalertinib twice daily (BID) monotherapy OR Arm B: Placebo BID monotherapy. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
Inclusion Criteria: 1. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology. 2. Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States \[US\]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt: 1. exon20 insertion mutations (ex20ins) or 2. other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain 3. Baseline imaging assessment of the brain (MRI \[preferred mod…
Oral tablets.
Oral tablets.