EMPATHY NSCLC: European Registry for Plasma-Based Molecul... | NCT07096258

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

NCT07096258

Sponsor

Hedera Dx SA

Status

Recruiting

Last Update Posted

Jul 31, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Not provided

Countries

France
Italy
Spain
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2031Estimated

First Submitted Date

Jul 24, 2025

First Submission Date that Met QC Criteria

Jul 24, 2025

First Posted Date

Jul 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2025

Last Update Posted Date

Jul 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
Advanced NSCLC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Actionable biomarkers	Proportion of patients with successful molecular profiling and detectable actionable biomarkers	At baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer Hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Christian Meisel, MD PhD	Contact	+41 21 588 16 54		HederaDxStudies@hederadx.com

Overall Officials

Name	Affiliation	Role
Dr. Christian Meisel, MD PhD	Hedera Dx	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Université de Lorraine	Recruiting	Nancy	Lorraine	54519	France
University of Naples "Federico II"

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Clinical investigators may request appropriate access to individual de-identified data via the EMPATHY NSCLC Steering Committee.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided