Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

Study Overview
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Brief Summary
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Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available. The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA. The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

Official Title
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Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

Conditions
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NSCLC, IMMUNOTHERAPY, QUANTIFICATION OF CELL-FREE DNA

Intervention / Treatment
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* Genetic: Molecular monitoring by quantification of cell-free DNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 informed of the objectives of the project and signed consent non small cell lung cancer, stage IIIA, IIIB or IV PS (WHO performance status) < or =2 treatment based on immunotherapy (monotherapy or combination) at least one measurable target available results of PD-L1 expression Exclusion Criteria: concomitant other type of cancer another cancer in the last 5 years

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: Experimental arm<br> | Genetic: Molecular monitoring by quantification of cell-free DNA<br>* Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, TMEM11) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients. Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes. Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit | The quantification of cell-free DNA is realized by droplet digital PCR (ddPCR) using two house-keeping genes (RPP30, TMEM11); if a somatic mutation is identified in the paired tumor DNA in routine practice, this mutation is also quantify in the cell-free DNA from plasma. The quantification of cell-free DNA corresponds to the variation from the time at inclusion and the time at the first radiological evaluation. The clinical benefit is defined by the duration of treatment by immunotherapy. | Inclusion visit - visit 2 (day 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease. | The quantification of cell-free DNA is realized by droplet digital PCR (ddPCR) using two house-keeping genes (RPP30, TMEM11); if a somatic mutation is identified in the paired tumor DNA in routine practice, this mutation is also quantify in the cell-free DNA from plasma. The earlier quantification of cell-free DNA corresponds to the variation from the time at inclusion and the time before the second administration of immunotherapy. | Inclusion visit, visit 1 (day 15), visit 2 (day 60), visit 3 (day 180), visit 4 (day 270), visit 5 (day 360), visit 6 (day 720), or early termination visit (in case of progression with end of immunotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Cell-free DNA, Immunotherapy, Digital PCR