Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Recruiting · NCT04720339 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Strasbourg, France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
8 locations listed.
- CHU de Besancon - Service de pneumologie - Besançon, France
- Hopitaux Civils de Colmar - service de Pneumologie - Colmar, France
- CHU de Dijon - service de Pneumologie - Dijon, France
- CLCC Georges-François Leclerc - Dijon, France
- GHR Mulhouse Sud-Alsace - Service de Pneumologie - Mulhouse, France
- CHU de Reims - service de Pneumologie - Reims, France
- CHRU de Strasbourg - Strasbourg, France
- Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy, France