NCT02515435

The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Apatinib as a Single Agent in Advanced NSCLC Who Failed to at Least Two Lines Systemic Treatment, or Were Not Amendable to Receive the Second-line Standard Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study, investigators reported an objective response rate of 68%. In a phase III trial conducted in advanced pretreated gastric cancer, the median overall survival was significantly prolonged in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and safety of apatinib in previously treated advanced non-squamous non-small cell lung cancer.

Detailed description

Observing the efficacy and safety of apatinib in heavily treated non-squamous non-small cell lung cancer. Primary Outcome Measure: Objective Response Rate Secondary Outcome Measures: Progression free survival, overall survival, Side effects, Quality Of Life

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	apatinib single agent	For those heavily treated non-squamous non-small cell lung cancer, treat with apatinib single agent, 500mg or 750mg Qd, p.o based on the status of patient, continue until disease progression, dose reduction was admitted

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-08-01
• Completion: 2017-12-01
• First posted: 2015-08-04
• Last updated: 2017-08-18

Locations

1 site across 1 country: China