Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, biopsy