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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)


Brief Summary
This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in four patient cohorts for up to 174 previously treated NSCLC patients with any systemic therapy (87 patients with EGFR exon 20 insertion mutations and 87 patients with HER2 exon 20 insertion mutations) and up to 140 treatment-naive NSCLC patients (70 patients with EGFR exon 20 insertion mutations and 70 patients with HER2 exon 20 insertion mutations).

Detailed 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 four patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status: - Cohort 1: Previously treated patients with EGFR exon 20 insertion mutation positive NSCLC - Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC - Cohort 3: Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC - Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutation positive 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 other protocol-specified reasons for patient withdrawal.



Inclusion and Exclusion Criteria

  • Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
  • Patient has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
  • Prior treatment status:
  • Cohorts 1 and 2: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
  • Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
  • Specific mutations:
  • Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
  • Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
  • Patient has adequate organ function at Baseline Key

  • 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. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible.
  • Patient has had radiotherapy (intention for cure) or surgery (other than surgical placement for vascular access and minimally invasive procedures including some biopsy procedures) within 2 weeks prior to start of study treatment with poziotinib
  • Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment
  • Patient is pregnant or breast-feeding


Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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