NCT04063462

Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation

A Phase 2 Study of Pyrotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), With at Least One Prior Systemic Treatment, Locally Advanced or Metastatic, With EGFR or ERBB2 Exon 20 Insertion Mutation (PEER20)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label study to evaluate the efficacy and the safety/tolerability of pyrotinib in previously treated NSCLC patients with EGFR exon 20 insertion mutations or HER2 exon 20 insertion mutations. Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	pyrotinib, single agent, 400mg p.o once daily until disease progressed

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-04-01
• Completion: 2021-10-01
• First posted: 2019-08-21
• Last updated: 2019-08-21

Locations

1 site across 1 country: China