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

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: Metastatic Non-small Cell Lung Cancer
• Intervention / Treatment: Other: ctDNA analysis

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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	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.	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	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	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	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

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Marc DENIS, CHD Vendée

Study record dates

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 (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• 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