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Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

I

Inivata

Status

Completed

Conditions

Non-Small Cell Lung Cancer

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03116633
GRN-ALV

Details and patient eligibility

About

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

Full 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).

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

34 participants in 3 patient groups

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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