Lung Cancer Clinical Trial
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
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.
Full 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 metastatic NSCLC harboring HER2 exon 20 mutations.
Participants will be randomized in a 2:1 ratio to:
Arm A: Poziotinib 8 milligrams (mg), twice daily (BID) or
Arm B: Docetaxel 75 milligrams per meter square (mg/m^2)
The Screening Period lasts up to 21 days prior to Cycle 1, Day 1 (C1D1). Participants will be treated in 21-day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There is 1 Location for this study
Winter Haven Florida, 33880, United States
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