NCT03811054

The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance. The purpose of this study is to investigate the efficacy and drug resistance mechanism of Apatinib combine with EGFR-TK1 treated for advanced slow progressed non-small cell lung cancer and provide new treatment options.

Detailed description

Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Previous studies demonstrated that the anti-angiogenesis combined with EGFR-TKI in slow-progressed EGFR mutation-positive non-small cell lung cancer achieved good efficacy and disease control rates, prolonged the progression free survival. The present study is aim to expand the number of samples to monitor resistance-related genes and tumor cells. Furthermore, to investigate the mechanism of anti-angiogenesis combine with EGFR-TKI and provide the theory for the use and promotion of clinically protocols. In this study, the primary objective is the objective response rates and the secondary goal are disease control rates, overall survival, progression free survival and drug safety.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatinib（250mg/d） combined with EGFR-TKI	Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-01-22
• Last updated: 2019-01-22

Locations

1 site across 1 country: China