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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Hedera Dx SA Industry-sponsored |
| Locations | 4 sites (Nancy, Lorraine and 3 other locations) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2031 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT07096258 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
- Study coordinator: Dr. Christian Meisel, MD PhD
- Email: HederaDxStudies@hederadx.com
- Phone: +41 21 588 16 54
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
-
AMT-116 vs doctor’s choice in advanced non-squamous NSCLC that is EGFR-wild and progressed after platinum and PD-1/PD-L1 therapy
This study tests AMT-116 in adults with advanced non-squamous NSCLC that is EGFR-wild, comparing different doses to doctor’s choice after prior platinum and immunotherapy.
-
SHY-ONC6: a new anti-cancer drug tested in adults with advanced solid tumors
This early-phase study tests SHY-ONC6 to see if it is safe and can help people with advanced solid tumors after standard therapies have failed.
-
Two-part Phase 1/2 test of ODM-212 combined with other cancer treatments
This trial tests the oral drug ODM-212, given alone or with approved medicines, to see if it helps adults with advanced mesothelioma, pancreatic cancer, or non-small cell lung cancer.
-
Vebreltinib with Platinum Chemotherapy as First-line Treatment for MET-Overexpressing NSCLC
This study tests whether adding vebreltinib to platinum-based chemotherapy can help adults with advanced NSCLC that overexpress MET and lack driver mutations respond to treatment as a first option.
-
Microwave ablation plus tislelizumab and docetaxel for advanced NSCLC after first-line immunotherapy progression
This treatment tests whether adding microwave ablation to tislelizumab and docetaxel can help people with advanced non‑small cell lung cancer whose disease progressed after first‑line immunotherapy plus chemotherapy.
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.