A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCL… (NCT05378763) | Clinical Trial Compass
SuspendedPhase 3
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
Stopped: The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.
United States268 participantsStarted 2022-05-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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