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Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC

Metastatic Non-small Cell Lung Cancer Clinical Trial

Official title:
Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC

Clinical Trial Summary

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety.

Clinical Trial Description

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety with overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and further evaluate subjects' duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety indicators of subjects are further evaluated through adverse events, vital signs and clinical laboratory parameters. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03300115
Study type Interventional
Source Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Contact Wanhong Xu, PhD
Phone +8657128908600
Email kayla.liu@aceapharma.com
Status Recruiting
Phase Phase 2
Start date May 18, 2017
Completion date December 17, 2020
View Details
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