Clinical trial NCT03926260: Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Non-small Cell Lung Cancer
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Eligibility 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

Primary outcomes:
measure: Biological response at week 3
timeFrame: week 3 after patient's recruitment date (baseline)
Secondary outcomes:
measure: Progression-free survival (radiological assessment) and biological response at week 3.
timeFrame: week 3 after baseline
measure: biological progression and radiological progression
timeFrame: progression
measure: biological response and radiological response
timeFrame: progression
measure: Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy
timeFrame: week 3 after baseline
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Marie MARCQ
city: Nantes
country: France
facility: Jaafar BENNOUNA
Study officials:
affiliation: CHD Vendee
name: Marc DENIS
role: PRINCIPAL_INVESTIGATOR
References: