NCT03129256

An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

An Exploratory Study of Low-dose Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Changzhou Cancer Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.

Detailed description

Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate tablet combined with S-1 capsules	Oral use with low-dose Apatinib combined with S-1 until disease progression

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2017-04-26
• Last updated: 2019-12-10

Locations

1 site across 1 country: China