Clinical Trial - NCT03318939

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

Recruiting

Sponsor: Spectrum Pharmaceuticals, Inc

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03318939

Protocol Info

Short Description: Phase 2 Poziotinib in NSCLC
Long Description: 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) (SPI-POZ-202)
MGH Status: Open
Sponsor: Spectrum Pharmaceuticals
Disease Program: Thoracic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 (Cohort 1: 87 patients with EGFR exon 20 insertion mutations, Cohort 2: 87 patients with HER2 exon 20 insertion mutations), up to 140 treatment-naive NSCLC patients (Cohort 3: 70 patients with EGFR exon 20 insertion mutations, Cohort 4: 70 patients with HER2 exon 20 insertion mutations). For Amendment 2, approximately 180 patients in Cohort 5 (60 patients per dose group), 30 patients in Cohort 6, and 30 patients in Cohort 7 are being added.
Condition Title Intervention Phase
NSCLC Poziotinib Phase 2
Study Type Interventional
Official Title 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)

Primary Outcome Measures

Objective Response Rate (ORR) [Time Frame: 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Disease Control Rate (DCR) [Time Frame: 24 months] [Designated as safety issue: ]

Duration of Response (DoR) [Time Frame: 24 months] [Designated as safety issue: ]

Estimated Enrollment: 554
Study Start Date: October 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: March 2023
Arms Assigned Interventions

Experimental:Poziotinib

Cohort 1: Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 2: Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 3: Treatment naive patients with EGFR exon 20 insertion-mutant positive NSCLC Cohort 4: Treatment naive patients with HER2 exon 20 insertion mutant positive NSCLC Cohort 5: Patients who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed Cohort 6: Patients with acquired EGFR mutation who progressed while on treatment with first-line osimertinib Cohort 7: Patients with EGFR or HER2 activating mutations
Drug:Poziotinib
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.
  • Cohort 5: Patients who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed
  • Cohort 6: Patients with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
  • Cohort 7: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
  • Specific mutations:
  • Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
  • Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
  • Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
  • Cohort 6: Documented acquired EGFR mutation
  • Cohort 7: Documented EGFR or HER2 activating mutations
  • 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 (Cohorts 1 to 4).
  • Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks; local radiation therapy for bone pain may be allowed
  • 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03318939

Locations

  • United States, California
    • Pacific Shores Medical Group Long Beach, California, United States, 90813
  • United States, New York
    • NYU Langone Medical Center New York, New York, United States, 10016
  • United States, North Carolina
    • Duke University Medical Center Durham, North Carolina, United States, 27710
  • United States, Texas
    • Texas Oncology- Austin Austin, Texas, United States, 78745
  • United States, Virginia
    • Virginia Cancer Specialists, PC Fairfax, Virginia, United States, 22031
  • United States, Washington
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109

Sponsors and Collaborators

Spectrum Pharmaceuticals, Inc

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03318939
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Spectrum Pharmaceuticals, Inc:

EGFR

HER2

Exon 20 insertion mutation

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019