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Recruiting NCT06849518

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

No phase Interventional Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Circulogene liquid biopsy testing.
Who it may be relevant to
Registry conditions: Lung Cancer (NSCLC). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response. [Time frame: up to 24 months]
Secondary outcome measures (1)
  • Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression. [Time frame: up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Ballad Health Cancer Care — Kingsport

Identifiers

NCT: NCT06849518 · 2276376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗