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

Centre Hospitalier Departemental Vendee

Status

Completed

Conditions

Metastatic Non-small Cell Lung Cancer

Treatments

Other: ctDNA analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT03926260

CHD 160-18

Details and patient eligibility

About

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.

Full 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

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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