Lung Cancer Clinical Trial

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

Summary

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

View Full Description

Full Description

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 seven 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 (closed to enrollment)
Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC (closed to enrollment)
Cohort 3: Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC (fully enrolled)
Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutation 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

Toxicity will be assessed based on the grade of the adverse events using CTCAE version 4.03.

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 (except for first progression in Cohort 5), death, intolerable adverse events (AEs), or other protocol-specified reasons for patient withdrawal.

View Eligibility Criteria

Eligibility Criteria

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 Cohorts 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 (tested after osimertinib progression)
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 and 2).
Patient 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
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

603

Study ID:

NCT03318939

Recruitment Status:

Recruiting

Sponsor:

Spectrum Pharmaceuticals, Inc

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 48 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
Oncology Physician's Network Inc./OPN Healthcare
Arcadia California, 91007, United States
City of Hope
Duarte California, 91010, United States
UCSD -Moores Cancer Center
La Jolla California, 92093, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles California, 90017, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
UCSF Helen Diller Comprehensive Cancer Center at Mt Zion
San Francisco California, 94115, United States
UCLA Hematology/Oncology
Santa Monica California, 90404, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance California, 90502, United States
Kaiser Permanente Medical Center
Vallejo California, 94589, United States
Rocky Mountain Cancer Center
Boulder Colorado, 80303, United States
Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale
New Haven Connecticut, 06510, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Florida Hospital
Orlando Florida, 32804, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.
Winter Haven Florida, 33881, United States
University Cancer & Blood Center, LLC
Athens Georgia, 30607, United States
CTCA - Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
CTCA - Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Highland Clinic, APMC
Shreveport Louisiana, 71105, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55404, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg Mississippi, 39401, United States
Montefiore Einstein Medical Center for Cancer Care
Bronx New York, 10461, United States
North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists
Bronx New York, 10469, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Langone Medical Center
New York New York, 10016, United States
Weill Cornell Medical College
New York New York, 10065, United States
North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa Oklahoma, 74146, United States
CTCA - Eastern Regional Medical Center
Philadelphia Pennsylvania, 19124, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Texas Oncology- Austin
Austin Texas, 78745, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, 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, T6G 1, Canada
BC Cancer - Vancouver
Vancouver British Columbia, V5Z 4, Canada
London Regional Cancer Program
London Ontario, N6A 5, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, 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
Be'er Sheva , , 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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

603

Study ID:

NCT03318939

Recruitment Status:

Recruiting

Sponsor:


Spectrum Pharmaceuticals, Inc

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider