This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in two patient cohorts for up to 114 previously treated NSCLC patients with any systemic therapy (57 patients with EGFR exon 20 insertion mutations and 57 patients with HER2 exon 20 insertion mutations).
Description: The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of poziotinib to the end of study.Measure: Objective response rate (ORR) Time: 24 months
Description: The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of poziotinib to the end of study.Measure: Disease Control Rate (DCR) Time: 24 months
Description: Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.Measure: Duration of Response (DoR) Time: 24 months
Description: Number of days from the treatment start date to the date of documented disease progression or death due to any cause.Measure: Progression-free Survival (PFS) Time: 24 months
Single Group Assignment
There is one SNP
Exclusion Criteria: 1. Patient has EGFR T790M mutation or any 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-selective tyrosine kinase inhibitor (TKI) prior to study participation. --- T790M ---