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ZENITH20: A phase II study of poziotinib in patients with non-small cell lung cancer, locally advanced or metastatic, with EGFR or HER2 exon 20 insertion mutation

Description

This is a phase II, 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).

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)

Status

Accepting new patients

Primary Study Objective(s)

The primary study objective is to evaluate the objective response rate to poziotinib in patients with non-small cell lung cancer (NSCLC) with EGFR or HER2 (ErBB2) exon 20 insertion mutations.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are willing to and (or through an authorized representative) capable of giving written informed consent and must be able to adhere to dosing and visit schedules, as well as meet all study requirements
  • Have histologically or cytologically confirmed non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC
  • Have these specific mutations:
    • Documented EGFR exon 20 insertion mutation
    • Documented HER2 exon 20 insertion mutation
  • Have had at least one prior systemic therapy for metastatic disease
  • Have adequate organ function at baseline
  • Are at least 18 years of age

Excluding patients who:

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

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