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NCT03318939

PHASE2

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

Sponsor: Spectrum Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

648

Start Date

2017-10-11

Completion Date

2023-04-03

Last Updated

2026-06-12

Healthy Volunteers

Conditions

NSCLC

Interventions

DRUG

Poziotinib

The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

Key Inclusion Criteria: * Participant must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements * Participant 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: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC * Cohorts 3 and 4: Participant 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: Participants who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed * Cohort 6: Participant with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib * Cohort 7: Participant 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 (tested after osimertinib progression) * Cohort 7: Documented EGFR or HER2 activating mutations * Participant has adequate organ function at Baseline Key Exclusion Criteria: * Participant 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 and 2). * Participant is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed * Participant 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 * Participant is pregnant or breast-feeding

Locations (63)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Oncology Physician's Network Inc./OPN Healthcare

Arcadia, California, United States

City of Hope

Duarte, California, United States

UCSD -Moores Cancer Center

La Jolla, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

UCSF Helen Diller Comprehensive Cancer Center at Mt Zion

San Francisco, California, United States

UCLA Hematology/Oncology

Santa Monica, California, United States

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

Rocky Mountain Cancer Center

Boulder, Colorado, United States

Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Florida Hospital

Orlando, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.

Winter Haven, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

CTCA - Southeastern Regional Medical Center

Newnan, Georgia, United States

CTCA - Midwestern Regional Medical Center

Zion, Illinois, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYU Langone Medical Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists

Port Jefferson Station, New York, United States

Montefiore Einstein Medical Center for Cancer Care

The Bronx, New York, United States

North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States

CTCA - Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Texas Oncology- Austin

Austin, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Saint Luc University Hospital

Brussels, Belgium

University Hospitals Leuven

Leuven, Belgium

Ambroise Pare University Hospital Center

Mons, Belgium

General Hospital Delta

Roeselare, Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

London Regional Cancer Program

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires

Toulouse, France

Gustave Roussy Oncology Institute, Department of Medical Oncology

Villejuif, France

Soroka Medical Center

Beersheba, Israel

Rambam Healthcare Campus

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

National Cancer Institute, IRCCS, Department of Medical Oncology

Milan, Italy

Santa Maria delle Croci Hospital

Ravenna, Italy

National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1

Rome, Italy

Erasmus Medical Center

Rotterdam, Netherlands

University Hospital Germans Trias i Pujol, Department of Medical Oncology

Barcelona, Spain

University Hospital 12 de Octubre

Madrid, Spain