Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 13, 2017
End Date:December 2022
Contact:Sanjay Mourya
Email:spi-poz-202@sppirx.com
Phone:(949)743-9322

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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)

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).

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.

Key Inclusion 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 Exclusion Criteria:

- 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
We found this trial at
6
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-606-7445
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Austin, Texas 78705
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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New York, New York 10016
Principal Investigator: Leena Gandhi, MD
Phone: 212-731-5111
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Orange, CA
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