EMPATHY NSCLC: European Registry for Plasma-Based Molecular Profiling in Advanced NSCLC Patients

NCT07096258 | Recruiting

• 1 other identifier: EMPATHY NSCLC
• Study Type: observational
• Target: 1,000
• Locations: 4 countries
• Sites: 4

Brief 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). 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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

• Actionable biomarkers

  Proportion of patients with successful molecular profiling and detectable actionable biomarkers

  At baseline

Study Arms (1)

Advanced NSCLC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer Hospitals

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hedera Dx SA: lead

Study Sites (4)

Université de Lorraine

Nancy, Lorraine, 54519, France

RECRUITING

University of Naples "Federico II"

Napoli, 80131, Italy

RECRUITING

General Universitario Gregorio Marañon

Madrid, 28007, Spain

NOT YET RECRUITING

Hôpitaux Universitaires Genève

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Christian Meisel, MD PhD

  Hedera Dx

  STUDY DIRECTOR

Central Study Contacts

Dr. Christian Meisel, MD PhD

CONTACT

+41 21 588 16 54; HederaDxStudies@hederadx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); CH (1); ES (1); IT (1)