Actively Recruiting
Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (Hereinafter: "Immunotherapy") in NSCLC in Palliative Therapy
Led by Karsten Gavenis · Updated on 2026-01-05
170
Participants Needed
3
Research Sites
153 weeks
Total Duration
On this page
Sponsors
K
Karsten Gavenis
Lead Sponsor
C
Chronix Biomedical Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, non-interventional, national study planned at three centers for patients with non-curative NSCLC receiving immunotherapy. At present, PD-L1 expression or tumor mutation burden serve as surrogate parameters for response to immunotherapy. However, the problem for clinicians is that not all patients with positive findings respond to this form of therapy. Cell-free DNA (cf-DNA) can be detected in blood plasma. Tumor cells almost always have chromosomal instabilities (or "copy-number variations" (CNV)), which can be detected using next-generation sequencing (NGS), also in the cf-DNA. These CNV can be quantified and given as a cf-DNA copy number instability score (CNI value). TheraSure CNI-Monitor is a highly sensitive method that can detect as little as 0.5% tumor DNA in plasma. In preliminary work in a cohort of 56 patients with various types of cancer (including: breast, colon, lung, ovary, melanoma) in advanced stages, the TheraSure CNI monitor was already evaluated in the monitoring of immunotherapy. In 51 of the 56 patients, increased CKD values were measured before the start of therapy compared to a normal group of 126 individuals. To predict the success of the therapy, further blood samples were used after the first and second therapy cycle and threshold values were set for the minimal expected decrease in the CNI value in the event of therapy response. A therapy failure could be predicted with a high positive predictive value, cases of hyperprogression could be detected earlier than by routine imaging. In addition, pseudoprogression could be distinguished from true progression using the CNI value. The CNI monitor on cell-free DNA is to be used prospectively in 170 patients. The primary objective of the study is the prediction of primary progression under immunomonotherapy (defined as PD within 6 months after RECIST) with a predictive value for progression (PPV) of ≥50%.
CONDITIONS
Official Title
Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (Hereinafter: "Immunotherapy") in NSCLC in Palliative Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older
- Diagnosed with non-curative stage III or stage IV NSCLC with palliative treatment indication
- Receiving immunocheckpoint-therapy for malignant disease (as monotherapy, double immunotherapy, or combined with chemotherapy)
You will not qualify if you...
- Unable to understand the nature, importance, and scope of the clinical trial
- Currently participating in an interventional study
- Hemoglobin value less than 9 g/dl
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
2
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
3
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
Actively Recruiting
Research Team
J
Jessica Rossian, Dr.
CONTACT
T
Tobias Overbeck, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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