NCT02540824

Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

A Phase II Clinical Trial to Investigate Efficacy and Safety of Apatinib as a Single Agent in RET-fusion Gene Positive Non-small Cell Lung Cancer Who Failed to Previous Treatment.

• 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

RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

Detailed description

To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatinib single agent arm	For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-09-04
• Last updated: 2015-09-04

Locations

1 site across 1 country: China