Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA (ELUCID)

November 27, 2025 updated by: Centre Hospitalier Departemental Vendee

Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers

In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.

Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.

An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche-sur-Yon, France, 85000
        • Marie MARCQ
      • Nantes, France, 44000
        • Jaafar BENNOUNA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
  • At least one measurable target according to RECIST criteria
  • Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
  • Performance Status 0 to 2
  • Affiliated to a social security system
  • Patient who can be followed under the protocol
  • Patient agreed to participate in the study and gave his/her express consent

Exclusion Criteria:

  • Minor
  • Small cell or mixed bronchial cancer
  • Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
  • Patient who has already started a first line of treatment
  • Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
  • History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
  • Patient which, does present a substantial risk of recurrence.
  • Major under guardianship, curators or deprived of liberty
  • Pregnant or lactating woman, or of childbearing age without effective contraception
  • Not affiliated to a social security system
  • Inability to understand the protocol and / or to give express consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ctDNA analysis
additional blood sample of 20 ml
Other: ctDNA analysis
blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological response at week 3
Time Frame: week 3 after patient's recruitment date (baseline)
Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.
week 3 after patient's recruitment date (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (radiological assessment) and biological response at week 3.
Time Frame: week 3 after baseline
Radiological assessment, based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1, will be: complete response, partial response, progression or stabilization. Biological response will be: increase, stability or decrease in ctDNA.
week 3 after baseline
biological progression and radiological progression
Time Frame: progression
Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression
progression
biological response and radiological response
Time Frame: progression
Biological response will be: increase, stability or decrease in ctDNA and Radiological response will be defined according to RECIST criteria v1.1 will be: complete or partial response
progression
Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy
Time Frame: week 3 after baseline
Radiological assessment, based on RECIST criteria v1.1, will be: complete response or partial response. Biological response will be: increase, stability or decrease in ctDNA.
week 3 after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Marc DENIS, CHD Vendee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 160-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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