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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2022-05-23

Brief Summary

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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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Detailed Description

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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

Conditions

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Metastatic Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ctDNA analysis

additional blood sample of 20 ml

Group Type EXPERIMENTAL

ctDNA analysis

Intervention Type OTHER

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

Interventions

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ctDNA analysis

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No