Status:
SUSPENDED
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 gro...
Detailed Description
This is a Phase 3, active-controlled, multicenter study to compare the efficacy and safety/tolerability of poziotinib versus docetaxel in previously treated participants with locally advanced or metas...
Eligibility Criteria
Inclusion
- Participant must:
- Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements
- Have histologically or cytologically confirmed NSCLC
- Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment
- 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.
- Have documentation of HER2 exon 20 mutation
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Have adequate hematologic, hepatic, and renal function at Baseline as per protocol
Exclusion
- Participant:
- Has had previous treatment with poziotinib for treatment of NSCLC
- Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations
- 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
- Has spinal cord compression or leptomeningeal disease
- Has a high risk of cardiac disease, as determined by the Investigator
- Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies
- Is unable to take drugs orally
- Is pregnant or breast-feeding
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2028
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT05378763
Start Date
May 12 2022
End Date
December 25 2028
Last Update
December 18 2025
Active Locations (1)
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1
Bond Clinic, P.A.
Winter Haven, Florida, United States, 33880