Clinical trial · Interventional
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
NCT06849518CI-TRIAL-00086593recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulogene liquid biopsy testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- plasma NGS ctDNA and plasma cfRNA PD-L1 expression
- interventionNames
- Diagnostic Test: Circulogene liquid biopsy testing
Primary outcomes (1)
- measure
- Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
- timeFrame
- up to 24 months
- description
- Circulogene ImmunoClear Assay
Secondary outcomes (1)
- measure
- Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.
- timeFrame
- up to 24 months
- description
- Circulogene ImmunoClear Assay
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.