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)

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Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Other Inclusion Criteria:

1. Patient has histologically or cytologically confirmed non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC 2.Documented EGFR exon 20 insertion mutation OR Documented HER2 exon 20 insertion mutation 3. Patient has adequate tumor tissue obtained from a biopsy or surgical procedure to enable molecular profiling for retrospective central laboratory confirmation of the mutation. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy prior to the study

1. Patient has EGFR T790M mutation or other acquired EGFR exon 20 point mutation 2. Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation tyrosine kinase inhibitor prior to study participation. 3. Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks; local radiation therapy for bone pain may be allowed.