TheraSure CNI-Monitor blood test for people with advanced NSCLC receiving immunotherapy
Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (Hereinafter: "Immunotherapy") in NSCLC in Palliative Therapy
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 |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Goettingen Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 3 sites (Göttingen, Lower Saxony and 2 other locations) |
| Trial ID | NCT05426668 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Göttingen, Lower Saxony and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.