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OpenTrials
Completed

NCT Number: NCT03926260

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marie MARCQ, La Roche-sur-Yon, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ctDNA analysis

Other

blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: ELUCID

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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