Lung Cancer (NSCLC)NCT06849518
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
A study testing Circulogene liquid biopsy testing in people with Lung Cancer (NSCLC), run by Ballad Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Circulogene liquid biopsy testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No anti-PD-1/L1 monoclonal antibody treatment.
- Planned primary radiation therapy.
- Small-cell lung cancer histology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ballad Health Cancer Care
Kingsport, Tennessee, 37660
Charles Mays, PhD, CCRP, CCRC, 423-431-5654, Charles.Mays@balladhealth.org
About this study
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)
- Being tested
- Circulogene liquid biopsy testing
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulogene liquid biopsy testingDiagnostic test
A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression.
| Study group | Role | What they receive |
|---|---|---|
| plasma NGS ctDNA and plasma cfRNA PD-L1 expression | Other | Not described Receives: Diagnostic Test: Circulogene liquid biopsy testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
Circulogene ImmunoClear Assay
Measured: up to 24 months
Secondary outcomes (1)
Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.
Circulogene ImmunoClear Assay
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start11 Feb 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ballad Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849518
- Sponsor's protocol ID
- 2276376
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
- ClinicalTrials.gov ID
- NCT06849518
- Acronym / sponsor ID
- 2276376
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ballad HealthUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| plasma NGS ctDNA and plasma cfRNA PD-L1 expression | Other | Diagnostic Test: Circulogene liquid biopsy testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- No anti-PD-1/L1 monoclonal antibody treatment.
- Planned primary radiation therapy.
- Small-cell lung cancer histology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulogene liquid biopsy testingA Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression. | Diagnostic test | plasma NGS ctDNA and plasma cfRNA PD-L1 expression |
Primary outcome
Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
Time frame: up to 24 months
Circulogene ImmunoClear Assay
1 secondary outcome
Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulogene liquid biopsy testing in people with Lung Cancer (NSCLC), run by Ballad Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Mays, PhD, CCRP, CCRC (423-431-5654, Charles.Mays@balladhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response. (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.