NCT04382300

Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions

Safety and Efficacy of Pyrotinib Combined With Thalidomide in Advanced Non-Small-Cell Lung Cancer With HER2 Exon 20 Insertions: A Prospective, Single-arm, Open-label Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in approximately 2% of non-small-cell lung cancers. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This is a prospective, single-arm, open-label phase II study, designed to evaluate the efficacy and safety of pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients with HER2 exon 20 insertions.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	pyrotinib combined with thalidomide	Single Group Assignment

Timeline

• Start date: 2020-06-30
• Primary completion: 2022-10-01
• Completion: 2023-04-01
• First posted: 2020-05-11
• Last updated: 2021-01-28

Locations

1 site across 1 country: China