T790M Plasma Testing Methodology Comparison and Clinical Validation

PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

December 23, 2016

Primary Completion Date

October 24, 2018

Study Completion Date

October 24, 2018

Conditions
Lung Cancer
Interventions
PROCEDURE

T790M+ Testing

The patient will need to have T790M+ testing

PROCEDURE

Baseline Visit Blood & Urine Testing

Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria

PROCEDURE

Baseline ECG

ECG to ensure absence of any cardiac abnormality

PROCEDURE

Visual Slit-Lamp Testing

Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms

DRUG

AZD9291 Dosing

Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)

PROCEDURE

Plasma AZD9291 testing

The patient will need to have plasma AZD9291 testing before treatment

Trial Locations (7)

130012

Research Site, Changchun

430022

Research Site, Wuhan

430030

Research Site, Wuhan

430079

Research Site, Wuhan

510080

Research Site, Guangzhou

610041

Research Site, Chengdu

710038

Research Site, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

TigerMed

INDUSTRY

lead

AstraZeneca

INDUSTRY