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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
250
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.
CHU de Besancon - Service de pneumologie
Besançon, France
RECRUITINGHopitaux Civils de Colmar - service de Pneumologie
Colmar, France
RECRUITINGCHU de Dijon - service de Pneumologie
Dijon, France
RECRUITINGCLCC Georges-François Leclerc
Dijon, France
NOT_YET_RECRUITINGGHR Mulhouse Sud-Alsace - Service de Pneumologie
Mulhouse, France
RECRUITINGCHU de Reims - service de Pneumologie
Reims, France
RECRUITINGCHRU de Strasbourg
Strasbourg, France
RECRUITINGInstitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
RECRUITINGPredictive 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.
Time frame: Inclusion visit - visit 2 (day 60)
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.
Time frame: 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)
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