T790M Plasma Testing Methodology comparison and clinical validation - ADELOS

Study identifier:D5160C00042

ClinicalTrials.gov identifier:NCT02997501

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Detect EGFR T790M mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, digital PCR and NGS and evaluate clinical outcomes of T790M mutation positive patients who had AZD9291 monotherapy

Medical condition

lung cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

AZD9291 Dosing

Sex

All

Actual enrollment

167

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 23 Dec 2016
Primary Completion Date: 24 Oct 2018
Study Completion Date: 24 Oct 2018

Study design

Allocation: N/A
Endpoint Classification: Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Nov 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Tigermed

Inclusion and exclusion criteria