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

Ballad Health

Status: Enrolling

Conditions: Lung Cancer (NSCLC)

Treatments: Diagnostic Test: Circulogene liquid biopsy testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06849518

2276376

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

plasma NGS ctDNA and plasma cfRNA PD-L1 expression

Other group

Treatment:

Diagnostic Test: Circulogene liquid biopsy testing