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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    603
  • sponsor
    Spectrum Pharmaceuticals, Inc
Updated on 20 September 2020
Investigator
Zang Yang, MD
Primary Contact
Georgetown University Medical Center (7.9 mi away) Contact
+67 other location
HER2
EGFR
stage iv non-small cell lung cancer
osimertinib

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-nave 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).

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 nave patients with EGFR exon 20 insertion mutation positive NSCLC (fully enrolled)
  • Cohort 4: Treatment nave 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 1.510^9/L and platelet count must be 10010^9/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.

Details
Treatment Poziotinib
Clinical Study IdentifierNCT03318939
SponsorSpectrum Pharmaceuticals, Inc
Last Modified on20 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
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-nave 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

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
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