NCT04720339
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Recruiting · Not Applicable · University Hospital, Strasbourg, France · registry updated 2022-11-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- concomitant other type of cancer
- another cancer in the last 5 years