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T790M Plasma Testing Methodology Comparison and Clinical Validation

NCT02997501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-03-04

Study results available
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Summary

The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.

Conditions

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

Sponsors & Collaborators

  • TigerMed

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Yilong WU · Guangdong General Hospita

  • Zhiyong LIANG · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-23
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997501 on ClinicalTrials.gov