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

Study Overview
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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.

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

Official Title
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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

Conditions
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Metastatic Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: ctDNA analysis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ctDNA analysis<br>additional blood sample of 20 ml | Other: ctDNA analysis<br>* blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (radiological assessment) and biological response at week 3. | 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. | week 3 after baseline | 
| biological progression and radiological progression | Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression | progression | 
| biological response and radiological response | 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 | progression | 
| Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy | 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. | week 3 after baseline |