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

NCT06849518 | Recruiting

• 1 other identifier: 2276376
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

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

  Circulogene ImmunoClear Assay

  up to 24 months

Secondary Outcomes (1)

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

  up to 24 months

Study Arms (1)

plasma NGS ctDNA and plasma cfRNA PD-L1 expression

OTHER

Diagnostic Test: Circulogene liquid biopsy testing

Interventions

Circulogene liquid biopsy testing DIAGNOSTIC_TEST

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

plasma NGS ctDNA and plasma cfRNA PD-L1 expression

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ballad Health: lead

Study Sites (1)

Ballad Health Cancer Care

Kingsport, Tennessee, 37660, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Charles Mays, PhD, CCRP, CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression will be drawn (i) pre-treatment, (ii) at cycle 2 treatment, (iii) every other cycle while on combined doublet chemotherapy-immune treatment, (iv) at 3 months post-starting treatment, (v) at 6 months post-starting treatment, and (vi) upon discontinuation of ICI treatment due to planned completed duration of ICI treatment or upon progressing disease. ICI treatment and radiographic evaluations will be standard of care as determined by the treating oncologist.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: February 11, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)