Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

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

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

Study Overview

• Status: Completed
• Conditions: Non-Small Cell 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).

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903
      • Mercy Hospital Cancer Center/Clinical Research
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Mercy Cancer Center
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Clinic Oncology & Hematology
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Networks
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Cancer Center & Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Arm A; 1st line setting-approx. 150 patients. collect tissue biopsy per standard of care & one blood draw (40ml)
Arm B; 1st line setting- approx. 100 patients one blood draw (40ml)
Arm C; Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.	The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis	Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis	12 months
Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis	Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy 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	Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited (Quantity Not Sufficient) versus that observed where tumour biopsy is achieved.	12 months

Collaborators and Investigators

• Sponsor: Inivata
• Collaborators: Guardian Research Network, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: lung cancer; biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GRN-ALV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No