NCT04339829

An Open Label, Multicenter, Phase II Study of Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, single-arm, open-label, Phase 2 clinical study of Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases.

Detailed description

The brain is a common site of metastases among patients with non-small-cell lung cancer (NSCLC).The incidence of CNS metastases in patients with EGFR mutation-positive NSCLC is 24% at first diagnosis almost doubles over the course of the disease. Several data has shown treatment with first generation EGFR-tyrosine kinase inhibitors (TKIs) can reduce the risk of progression in the CNS, compared with chemotherapy or WBRT.Pre-clinical data showing that brain homogenate dacomitinib concentrations is similar to plasma in mice. While, there are evidence show that dacomitinib have efficacy in NSCLC patients with BM. This phase II study was designed to prospectively evaluate the efficacy and safety of Dacomitinib in NSCLC patients with BM.

Conditions

• Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases

Interventions

Type	Name	Description
DRUG	Dacomitinib	Dacomitinib orally on a continuous daily basis at a starting dose of 45 mg QD

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-07-01
• Completion: 2023-08-30
• First posted: 2020-04-09
• Last updated: 2020-04-09