drugset / Trial / NCT05378763

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

NCT05378763

Phase 3 Suspended 268 enrolled Spectrum Pharmaceuticals, Inc
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-12
Primary completion
2027-12-25
Completion
2028-12-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Poziotinib Small molecule 8 mg Oral