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A Randomized, Phase 3 Study of Poziotinib in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring HER2 Exon 20 Mutations (PINNACLE)

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, initiation of non-protocol anti-cancer treatment or other protocol-specified reasons.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine progression free survival

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet these 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

Excluding patients who meet these 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
  • Is unable to take drugs orally
  • Is pregnant or breast-feeding
     

Accepting new patients

 

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