Clinical trial Recruiting at 3 sites Observational Ages 18 and up

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

Official title: 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.

Run by Hedera Dx SA · NCT07096258 · Data updated 2026-11-12

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.

More NSCLC (Advanced Non-small Cell Lung Cancer) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorHedera Dx SA
Industry-sponsored
Locations4 sites (Nancy, Lorraine and 3 other locations)
StatusRecruiting
StartedJune 1, 2024
Main results expectedDecember 2027
Study endsDecember 2031
Registry record updatedJuly 31, 2025
Trial IDNCT07096258 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Université de Lorraine
    Nancy, Lorraine, France
    Recruiting
  • University of Naples "Federico II"
    Naples, Italy
    Recruiting
  • Hôpitaux Universitaires Genève
    Geneva, Canton of Geneva, Switzerland
    Recruiting
  • General Universitario Gregorio Marañon
    Madrid, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.