SuspendedPhase 3NCT05378763

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

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.

Checked against the public recordLast updated Jul 24, 2026 · Source: ClinicalTrials.gov

StatusSuspended
PhasePhase 3
U.S. locations1
SponsorSpectrum Pharmaceuticals, Inc
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Spectrum Pharmaceuticals, Inc
Interventions being studied
Drug: Poziotinib; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated. 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 on current imaging studies 7. Is unable to take drugs orally 8. Is pregnant or breast-feeding

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Bond Clinic, P.A.Winter Haven, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 24, 2026. Always confirm current availability with the study team.

View original record ↗