TheraSure CNI-Monitor blood test for people with advanced NSCLC receiving immunotherapy
Official title: Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (Hereinafter: "Immunotherapy") in NSCLC in Palliative Therapy
Run by University Medical Center Goettingen · NCT05426668 · Data updated 2026-11-12
This will test whether a blood-based TheraSure CNI-Monitor can detect tumor DNA changes and help predict or track response in adults with non-curative (stage III/IV) NSCLC who are receiving immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | University Medical Center Goettingen Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 3 sites (Göttingen, Lower Saxony and 2 other locations) |
| Status | Recruiting |
| Started | February 24, 2025 |
| Main results expected | November 2027 |
| Study ends | February 2028 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT05426668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with non-curatively treatable stage III or IV NSCLC who are receiving immunotherapy (monotherapy, dual immunotherapy, or immunotherapy plus chemotherapy) and can give informed consent are eligible.
✕Probably not a fit
Patients with curative disease, those not receiving immunotherapy, those with severe anemia (Hb < 9 g/dL), or those unable to give informed consent are unlikely to benefit from or be eligible for this observational validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-interventional multicenter study at three German sites that collects blood plasma from patients with non-curative stage III or IV NSCLC receiving immunotherapy. Cell-free DNA in plasma will be analyzed by next-generation sequencing to quantify copy-number instability (CNI) using the TheraSure CNI-Monitor, which is sensitive to low tumor DNA fractions. Researchers will correlate CNI scores over time with patients' clinical course and treatment outcomes without changing standard care. The aim is to validate whether serial CNI measurements can serve as a minimally invasive marker of response or progression during immunotherapy.
Why it matters
Potential benefit: If successful, the test could provide a simple blood-based way to predict and monitor which patients benefit from immunotherapy, enabling earlier and better-informed treatment decisions.
How similar studies have gone: Prior small cohorts and other cfDNA/CNV-based approaches have shown promise detecting tumor-derived DNA and correlating with outcomes, but broad validation specifically in NSCLC patients on immunotherapy is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent form * Age ≥18 years * NSCLC, non-curatively treatable stage III or stage IV with palliative treatment indication * Immunocheckpoint-therapy for malignant disease (Immunotherapy as monotherapy, double immunotherapy or combination with chemotherapy) Exclusion Criteria: * Person is unable to understand the nature, importance and scope of the clinical trial * Participation in an interventional study * Hb value \<9g/dl
Where it's running
-
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany Recruiting -
Medizinische Hochschule Hannover
Hanover, Germany Recruiting -
Pius-Hospital Oldenburg
Oldenburg, Germany Recruiting
Study contacts
- Study coordinator: Jessica Rossian, Dr.
- Email: jessica.rossian@med.uni-goettingen.de
- Phone: +49 551-39-62362
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.