EMPATHY NSCLC: European registry of blood-based molecular profiling in advanced NSCLC

A Patient Registry Collecting the Clinical and Molecular Profiling Data of Patients With Locally Advanced and/or Metastatic, Unresectable, Stages IIIB/C or IV Non-small Cell Lung Cancer (NSCLC), Who Have Not Previously Been Treated for This Advanced Disease and Are Therefore Considered as Patients Receiving First-line Therapy.

This registry will collect real-world data to see if blood (plasma) and tissue molecular profiling help guide first-line treatment and outcomes for people starting therapy for advanced non-small cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hedera Dx SA (Industry-sponsored)
• Locations: 4 sites (Nancy, Lorraine and 3 other locations)
• Trial ID: NCT07096258 on ClinicalTrials.gov

What this trial studies

EMPATHY NSCLC is an observational European registry enrolling adults with untreated locally advanced or metastatic NSCLC who are about to start first-line systemic therapy. The registry captures paired plasma- and tissue-based molecular profiling results, treatments chosen, clinical outcomes, and patient-reported outcomes across participating centers. No experimental treatments are assigned; investigators record how molecular testing influences treatment decisions and subsequent outcomes in routine practice. The project aims to describe testing patterns, concordance between plasma and tissue results, and associations between molecular profiles and real-world effectiveness and safety.

Who should consider this trial

Good fit: Adults (≥18) with untreated, unresectable locally advanced (IIIB/C) or metastatic (IV) NSCLC who intend to start first-line systemic therapy and have ECOG performance status ≤2 are the ideal candidates.

Not a fit: Patients who have already received treatment for advanced NSCLC, those with another recent malignancy within five years, or those unable or unwilling to consent or provide required samples are unlikely to benefit from enrolling.

Why it matters

Potential benefit: If successful, the registry could help clinicians better match patients to targeted or immunotherapies and clarify when plasma testing is a reliable alternative to tissue biopsy.

How similar studies have performed: Multiple prior studies have shown that plasma-based 'liquid biopsy' can detect actionable mutations and guide therapy in NSCLC, while prospective real-world registries provide complementary evidence on routine practice and outcomes.

Eligibility criteria

Inclusion Criteria:

* Locally advanced or metastatic, unresectable NSCLC, stages IIIB/C or IV, who have not previously been treated for this advanced disease.
* Intention-to-initiate first-line tumour therapy for this advanced disease.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* At least 18 years of age on the day of signing informed consent, and capable of signing informed consent.

Exclusion Criteria:

* Any known non-cutaneous malignancy (except for this NSCLC and early-stage non-invasive cervical cancer) that has occurred within 5 years prior to enrolment.

Where this trial is running

Nancy, Lorraine and 3 other locations

• Université de Lorraine — Nancy, Lorraine, France (Recruiting)
• University of Naples "Federico II" — Naples, Italy (Recruiting)
• General Universitario Gregorio Marañon — Madrid, Spain (Not_yet_recruiting)
• Hôpitaux Universitaires Genève — Geneva, Canton of Geneva, Switzerland (Recruiting)

Study contacts

• Study coordinator: Dr. Christian Meisel, MD PhD

Conditions NSCLC