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).
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 48 Locations for this study
Phoenix Arizona, 85054, United States
Arcadia California, 91007, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Long Beach California, 90813, United States
Los Angeles California, 90017, United States
Los Angeles California, 90033, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Santa Monica California, 90404, United States
Torrance California, 90502, United States
Vallejo California, 94589, United States
Boulder Colorado, 80303, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32804, United States
Tampa Florida, 33612, United States
Winter Haven Florida, 33881, United States
Athens Georgia, 30607, United States
Newnan Georgia, 30265, United States
Zion Illinois, 60099, United States
Shreveport Louisiana, 71105, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Rochester Minnesota, 55905, United States
Hattiesburg Mississippi, 39401, United States
Bronx New York, 10461, United States
Bronx New York, 10469, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10065, United States
Port Jefferson Station New York, 11776, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Tulsa Oklahoma, 74146, United States
Philadelphia Pennsylvania, 19124, United States
Memphis Tennessee, 38120, United States
Austin Texas, 78745, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States
Brussels , , Belgium
Leuven , , Belgium
Mons , , Belgium
Roeselare , , Belgium
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 2, Canada
Toulouse , , France
Villejuif , , France
Be'er Sheva , , Israel
Haifa , , Israel
Jerusalem , , Israel
Petah Tikva , , Israel
Milan , , Italy
Ravenna , , Italy
Rome , , Italy
Rotterdam , , Netherlands
Barcelona , , Spain
Madrid , , Spain
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.