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

NCT03926260 | Completed

• 1 other identifier: CHD 160-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (radiological assessment) and biological response at week 3.

  week 3 after baseline

• biological progression and radiological progression

  progression

• biological response and radiological response

  progression

• Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy

  week 3 after baseline

Study Arms (1)

ctDNA analysis

EXPERIMENTAL

additional blood sample of 20 ml

Other: ctDNA analysis

Interventions

ctDNA analysis OTHER

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

ctDNA analysis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Marie MARCQ

La Roche-sur-Yon, 85000, France

Location

Jaafar BENNOUNA

Nantes, 44000, France

Location

Related Publications (1)

• Herbreteau G, Marcq M, Sauzay C, Carpentier M, Pierre-Noel E, Pons-Tostivint E, Vallee A, Theoleyre S, Bizieux A, Bennouna J, Denis MG. Absolute Quantification of Nucleotide Variants in Cell-Free DNA via Quantitative NGS: Clinical Application in Non-Small Cell Lung Cancer Patients. Cancers (Basel). 2025 Feb 25;17(5):783. doi: 10.3390/cancers17050783.

  PMID: 40075630 BACKGROUND

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

• Marc DENIS

  CHD Vendee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: June 27, 2019
• Primary Completion: July 30, 2021
• Study Completion: May 23, 2022
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)