A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
NCT07128199
Original registry description
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.