A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
Megadott ok: The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.
Key facts
- Where
- Winter Haven, Egyesült ÁllamokSee the site
- Phase
- 3. fázis
Where in Egyesült Államok
- Bond Clinic, P.A.Winter Haven, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Spectrum Pharmaceuticals, Inc
- Trial code
- NCT05378763
- Record updated
- 2026. október 28.
- Original description
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.Read full original descriptionShow less
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)
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.
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: Has had previous treatment with poziotinib for treatment of NSCLC; 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; Is unable to take drugs orally; 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; Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations; Participant:; Is pregnant or breast-feeding.