Evaluating ctDNA diagnostics for Stage III lung cancer

GUIding Multi-moDal thErapies Against MRD by LiquidBiopsies in Non Small Cell Lung Cancer- GUIDE.MRD-03-NSCLC

This study is testing how well blood tests that check for tumor DNA can help people with Stage III lung cancer during and after their treatment.

Quick facts

• Study type: Observational
• Enrollment: 248 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 6 sites (Nice, Nice and 5 other locations)
• Trial ID: NCT06111807 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate and benchmark the performance of circulating tumor DNA (ctDNA) diagnostics in patients with Stage III non-small cell lung cancer (NSCLC). By analyzing blood samples from patients undergoing curative treatment, the study seeks to determine which ctDNA tests are most effective at various clinical stages, such as post-surgery and during treatment surveillance. The GUIDE.MRD consortium, comprising experts from various fields, will collect and analyze these samples to establish reliable standards for ctDNA testing and improve personalized treatment strategies for lung cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Stage III NSCLC who are scheduled for curative treatment.

Not a fit: Patients with distant metastases or other concurrent cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate treatment decisions for lung cancer patients, ensuring they receive the appropriate level of care.

How similar studies have performed: Other studies have shown promise in using ctDNA diagnostics for cancer monitoring, but this specific benchmarking approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* NSCLC, clinical tumor stage III (cT1-4, cN0-3, M0).
* Patient 18 years or older.
* Scheduled for curative intent treatment (surgery and/or radiotherapy).
* Patient able to understand and sign written informed consent.
* Baseline contrast enhanced CT thorax abdomen (or PET/CT), MRI (or CT) brain, Pulmonary function tests (at least FEV1 and DLCO/KCO).
* Ability to obtain sufficient tumor material (≥50ng tumor DNA, FFPE ). Either at baseline or after surgery.

Exclusion Criteria:

* Verified distant metastases.
* With synchronous NSCLC cancer and non-NSCLC cancer (except skin cancer other than melanoma).
* With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
* No tissue sample available for the project, or tumor content in the tissue sample is \<20%

Where this trial is running

Nice, Nice and 5 other locations

• Centre Hospitalier Universitaire de Nice — Nice, Nice, France (Recruiting)
• Antoine Lacassagne Center — Nice, Nice, France (Not_yet_recruiting)
• Department of thoracic oncology- LungenClinic Großhansdorf — Großhansdorf, Grosshansdorf, Germany (Not_yet_recruiting)
• Isala — Zwolle, Overijssel, Netherlands (Recruiting)
• University Medical Center Groningen, Departments of Pulmonology and Pathology — Groningen, Provincie Groningen, Netherlands (Recruiting)
• Ommelander Ziekenhuis Groningen — Scheemda, Provincie Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: T.Jeroen N Hiltermann, MD, PhD

Conditions Lung Cancer Stage III; Circulating tumor DNA; ctDNA diagnostics; Minimal residual disease; Sensitivity; Specificity; complete pathological response