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NCT Number: NCT06849518

Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer

This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ballad Health Cancer Care

Kingsport, Tennessee, 37660, United States

Location status: Recruiting

Location contact

Charles Mays, PhD, CCRP, CCRC

CONTACT

[email protected]

423-431-5654

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment.
  • Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody.
  • A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.

Exclusion criteria

  • No anti-PD-1/L1 monoclonal antibody treatment.
  • Planned primary radiation therapy.
  • Small-cell lung cancer histology.

Treatment and study plan

Circulogene liquid biopsy testing

Diagnostic Test

A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression.

Primary outcomes

  1. Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.

    Time frame: up to 24 months

    Circulogene ImmunoClear Assay

Secondary outcomes

  1. Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.

    Time frame: up to 24 months

    Circulogene ImmunoClear Assay

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Mays, PhD, CCRP, CCRC

CONTACT

[email protected]

423-431-5654

Sponsors and collaborators

Lead sponsor

Ballad Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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