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Phase II

A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (POZITIVE20-1)

  • Study HIC#:2000022015
  • Last Updated:01/01/0001

This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in up to 174 patients with NSCLC exon 20 insertion mutations (87 patients with EGFR exon 20 insertion mutations and 87 patients with HER2 exon 20 insertion mutations).

  • Start Date05/18/2018
  • End Date10/18/2020

Trial Purpose and Description

The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to undergoing any study procedures.

Each treatment cycle is 28 calendar days in duration. There will be two cohorts and eligible patients will be enrolled into each cohort based on EGFR or HER2 exon 20 mutant status:

  • Cohort 1: Patients with EGFR exon 20 insertion-mutant non-small cell lung cancer (NSCLC)
  • Cohort 2: Patients with HER2 exon 20 insertion-mutant non-small cell lung cancer (NSCLC)

Toxicity will be assessed based on the grade of the adverse events using CTCAE version 4.03.

All treatments will be taken orally, once daily (QD) at approximately the same time each morning. On Day 1 of each 28-day cycle, the patient's absolute neutrophil count (ANC) must be ≥1.5×10^9/L and platelet count must be ≥100×10^9/L before administering poziotinib. All patients will be treated until disease progression, death, intolerable adverse events, or up to a maximum of 24 months, whichever comes first.

Eligibility Criteria

Inclusion Criteria:

  • Patient, or patient's authorized representative, must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
  • Patient has histologically or cytologically confirmed non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC
  • Specific mutations:
    • Documented EGFR exon 20 insertion mutation
    • Documented HER2 exon 20 insertion mutation
  • Patient has had at least one prior systemic therapy for metastatic disease
  • Patient has adequate organ function at Baseline
  • Patient is at least 18 years of age

Exclusion Criteria:

  • Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation tyrosine kinase inhibitor prior to study participation
  • Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment
  • Patient has a history of other malignancies within the last 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervix
  • Patient is pregnant or breast-feeding


For more information about this study, contact: