NCT03389256

Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC

A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.

Conditions

• Lung Diseases
• Neoplasms
• Respiratory Tract Diseases
• Thoracic Neoplasms
• Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.
DRUG	EGFR-TKI	Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po

Timeline

• Start date: 2018-12-30
• Primary completion: 2020-12-30
• Completion: 2022-08-30
• First posted: 2018-01-03
• Last updated: 2018-01-03

Locations

3 sites across 1 country: China