NCT05378763

A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

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)

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Poziotinib	Poziotinib tablets
DRUG	Docetaxel	Docetaxel IV infusion

Timeline

• Start date: 2022-05-12
• Primary completion: 2027-12-25
• Completion: 2028-12-25
• First posted: 2022-05-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study