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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03926260

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted December 17, 2020

Study Description

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.

  • Condition or Disease:Metastatic Non-small Cell Lung Cancer
  • Intervention/Treatment: Other: ctDNA analysis
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: February 2023
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Agnes DORION 2.51.44.63.80 ext +33 agnes.dorion@chd-vendee.fr

Locations

France
Marie MARCQ
La Roche-sur-Yon

France
Jaafar BENNOUNA
Nantes

Sponsors and Collaborators

Centre Hospitalier Departemental Vendee

Investigators

Principal Investigator: Marc DENIS CHD Vendee

More Information
  • Responsible Party: Centre Hospitalier Departemental Vendee
  • ClinicalTrials.gov Identifier: NCT03926260 History of Changes
  • Other Study ID Numbers: CHD 160-18
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: December 17, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Neoplasms Carcinoma, Non-Small-Cell Lung