Recruiting

Immunotherapy

Sponsor:

Ballad Health

Code:

NCT06849518

Conditions

Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Circulogene liquid biopsy testing

Study Details

Brief summary:

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.

Conditions

Lung Cancer (NSCLC)

Study ID

NCT06849518

Start date

Feb 11, 2025

Status verified date

Feb, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. 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.
3. 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:

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: plasma NGS ctDNA and plasma cfRNA PD-L1 expression

Interventions

Circulogene liquid biopsy testing

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

Primary outcome measure

  • Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response. [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Charles Mays, PhD, CCRP, CCRC

423-431-5654Charles.Mays@balladhealth.org

Locations

Ballad Health Cancer Care

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Charles Mays, PhD, CCRP, CCRC

423-431-5654Charles.Mays@balladhealth.org

More Information

Sponsor

Ballad Health

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ballad Health on 2025-02-28.