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

Outcome

Outcome not reported

Stopped (Enrollment): “The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.”

Drugs

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