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Clinical Trial 19387

Cancer Type:
Interventions:Poziotinib

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Eric Haura

Overview

Study Title

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)

Summary

This study is for an investigational study drug called poziotinib for the treatment for EGFR or HER2 Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer. Poziotinib is a new type of treatment and is considered investigational. "Investigational" means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) because we do not know enough about the benefits or side effects of poziotinib in the treatment for EGFR or HER2 Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer.

Objective

Primary Objective: -To evaluate the Objective Response Rate (ORR) to poziotinib in patients with non-small cell lung cancer (NSCLC) with EGFR or HER2 (ErBB2) exon 20 insertion mutations. Secondary Objectives: - To evaluate other efficacy variables of poziotinib in patients with NSCLC with EGFR or HER2 exon 20 insertion mutations, including the following: -Disease Control Rate (DCR) (complete response + partial response + stable disease). -Duration of Response (DoR). -To evaluate the safety and tolerability of poziotinib in patients with NSCLC with EGFR or HER2 exon 20 insertion mutations.

Inclusion Criteria

  • Participant, 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.
  • Participant has histologically or cytologically confirmed non-small cell lung cancer not amenable to curative intent therapy or stage IV Non-small Cell Lung Cancer (NSCLC).
  • Specific mutations: Documented EGFR exon 20 insertion mutation; Documented HER2 exon 20 insertion mutation.
  • Has had at least one prior systemic therapy for metastatic disease.
  • Adequate organ function at Baseline.
  • At least 18 years of age.

  • Exclusion Criteria

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