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

NCT ID: NCT06849518

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer (NSCLC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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plasma NGS ctDNA and plasma cfRNA PD-L1 expression

Group Type OTHER

Circulogene liquid biopsy testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Circulogene liquid biopsy testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ballad Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ballad Health Cancer Care

Kingsport, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charles Mays, PhD, CCRP, CCRC

Role: CONTACT

423-431-5654

Facility Contacts

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Charles Mays, PhD, CCRP, CCRC

Role: primary

423-431-5654

Other Identifiers

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2276376

Identifier Type: -

Identifier Source: org_study_id

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