NSCLC (Advanced Non-small Cell Lung Cancer)EMPATHY NSCLCNCT07096258
EMPATHY NSCLC: European Registry for Plasma-Based Molecular Profiling in Advanced NSCLC Patients
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Hedera Dx SA at 4 sites in 4 countries.
Trial summary
The goal of this registry is to capture real-world data from plasma- and tissue-based molecular profiling, treatments, outcomes and patient-reported outcomes from patients with advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Jun 2024to Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Hospitals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
France1 site, 1 recruiting
- Recruiting
Université de Lorraine
Nancy, Lorraine, 54519
Italy1 site, 1 recruiting
- Recruiting
University of Naples "Federico II"
Naples, 80131
Spain1 site, 1 recruiting
- Not yet recruiting
General Universitario Gregorio Marañon
Madrid, 28007
Switzerland1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires Genève
Geneva, Canton of Geneva, 1211
About this study
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.
The goal of this registry is to capture real-world data from plasma- and tissue-based molecular profiling, treatments, outcomes and patient-reported outcomes from patients with advanced or metastatic non-small cell lung cancer (NSCLC). The main objective of the study is to better understand the real-world clinical practice of the use and utility of molecular tumour profiling, the choice of treatment, and the outcome after such molecular profiling and treatment.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actionable biomarkers
Proportion of patients with successful molecular profiling and detectable actionable biomarkers
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hedera Dx SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Christian Meisel, MD PhD, Study director, Hedera Dx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096258
- Sponsor's protocol ID
- EMPATHY NSCLC
- Acronym
- EMPATHY NSCLC
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical investigators may request appropriate access to individual de-identified data via the EMPATHY NSCLC Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07096258
- Acronym / sponsor ID
- EMPATHY NSCLC / EMPATHY NSCLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hedera Dx SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this registry is to capture real-world data from plasma- and tissue-based molecular profiling, treatments, outcomes and patient-reported outcomes from patients with advanced or metastatic non-small cell lung cancer (NSCLC). The main objective of the study is to better understand the real-world clinical practice of the use and utility of molecular tumour profiling, the choice of treatment, and the outcome after such molecular profiling and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Hospitals
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Actionable biomarkers
Time frame: At baseline
Proportion of patients with successful molecular profiling and detectable actionable biomarkers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. Clinical investigators may request appropriate access to individual de-identified data via the EMPATHY NSCLC Steering Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Christian Meisel, MD PhD study director
Hedera Dx
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Hedera Dx SA at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Italy, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Christian Meisel, MD PhD (+41 21 588 16 54, HederaDxStudies@hederadx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actionable biomarkers (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.