NCT02815007

Chidamide With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

Chidamide With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer: An Open-label, Single-armed Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yuankai Shi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

Detailed description

(1)The efficacy of the regimen is evaluated by objective remission rate, disease control rate, progress free survival, duration of remission, overall survival, time to progression. Safety is monitored by vital signs, blood routine test, liver function, kidney function and electrolytes level, ECG, and cardiac ultrasonography. All the data is documented by CRF form, and carefully preserved.

Conditions

• Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chidamide with EGFR-TKI	Chidamide and EGFR-TKI, dosage described in arm description.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2016-06-28
• Last updated: 2016-06-28