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A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer, (NSCLC), Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)
This study is for an investigational study drug called poziotinib for the treatment for EGFR or HER2 Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer. Poziotinib is a new type of treatment and is considered investigational. "Investigational" means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) because we do not know enough about the benefits or side effects of poziotinib in the treatment for EGFR or HER2 Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer.
Primary Objective: -To evaluate the Objective Response Rate (ORR) to poziotinib in patients with non-small cell lung cancer (NSCLC) with EGFR or HER2 (ErBB2) exon 20 insertion mutations. Secondary Objectives: - To evaluate other efficacy variables of poziotinib in patients with NSCLC with EGFR or HER2 exon 20 insertion mutations, including the following: -Disease Control Rate (DCR) (complete response + partial response + stable disease). -Duration of Response (DoR). -To evaluate the safety and tolerability of poziotinib in patients with NSCLC with EGFR or HER2 exon 20 insertion mutations.