Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

• ClinicalTrials.gov Identifier: NCT03116633
• Recruitment Status: Completed
• First Posted: April 17, 2017
• Last Update Posted: May 16, 2019
• Sponsor: Inivata
• Collaborator: Guardian Research Network, Inc.
• Information provided by (Responsible Party): Inivata

Tracking Information

• First Submitted Date: April 5, 2017
• First Posted Date: April 17, 2017
• Last Update Posted Date: May 16, 2019
• Actual Study Start Date: June 30, 2017
• Actual Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2017)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 11, 2017)

• Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
  Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
• Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
  Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
• Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved [ Time Frame: 12 months ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy
• Official Title: 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
• 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).
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
• Condition: Non-Small Cell Lung Cancer
• Intervention: Not Provided

Study Groups/Cohorts

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2019): 34
• Original Estimated Enrollment (submitted: April 11, 2017): 260
• Actual Study Completion Date: December 31, 2018
• Actual Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03116633
• Other Study ID Numbers: GRN-ALV
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Inivata
• Study Sponsor: Inivata
• Collaborators: Guardian Research Network, Inc.
• Investigators: Not Provided
• PRS Account: Inivata
• Verification Date: May 2019