An Observational Multicenter Study to Evaluate the Performance and Utility of Inivata Liquid Biopsy Analysis Compared With Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Lung Cancer

Inivata6 sites in 1 country34 target enrollmentJune 30, 2017

ConditionsNon-Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: Inivata
Enrollment: 34
Locations: 6
Primary Endpoint: Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer

Detailed Description

The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Registry

clinicaltrials.gov

Start Date

June 30, 2017

End Date

December 31, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Inivata

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written, signed and dated informed consent
•Male \& female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
•Patients intended to initiate first-line treatment (Arms A and B)
•Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A)
•Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.

Exclusion Criteria

•Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy
•Any history of metastatic cancer.
•Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix).
•Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality

Outcomes

Primary Outcomes

Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.

Time Frame: 12 months

The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.

Secondary Outcomes

Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis(12 months)
Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis(12 months)
Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved(12 months)