Overview

A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

Status:
Recruiting

Trial end date:
2028-12-25

Target enrollment:
0

Participant gender:
All

Summary

The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Spectrum Pharmaceuticals, Inc

Treatments:

Docetaxel

Criteria

Inclusion Criteria:

Participant must:

1. Be willing and capable of providing signed and dated Informed Consent, adhering to
dosing and visit schedules, and meeting the study requirements

2. Have histologically or cytologically confirmed NSCLC

3. Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment

4. Participant has had at least one prior systemic treatment for locally advanced or
metastatic NSCLC, including platinum or checkpoint inhibitor (CPI) therapy

5. Have documentation of HER2 exon 20 mutation

6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

7. Have adequate hematologic, hepatic, and renal function at Baseline as per protocol

Exclusion Criteria:

Participant:

1. Has had previous treatment with poziotinib for treatment of NSCLC

2. Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations

3. Has had previous treatment with docetaxel for locally advanced or metastatic NSCLC. If
docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease
must have occurred ≥6 months after the last dose to be eligible

4. Has spinal cord compression or leptomeningeal disease

5. Has a high risk of cardiac disease, as determined by the Investigator

6. Has a history of, or signs of Grade ≥2 pneumonitis or interstitial lung disease on
current imaging studies

7. Is unable to take drugs orally

8. Is pregnant or breast-feeding