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

256

Study type

Interventional

Age

18 Years - 130 Years

Date

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

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Tigermed

Inclusion and exclusion criteria