RecruitingNot ApplicableNCT04720339

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

Sponsor

University Hospital, Strasbourg, France

Enrollment

250 participants

Start Date

May 27, 2021

Study Type

INTERVENTIONAL

Conditions

NSCLC

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria2

concomitant other type of cancer
another cancer in the last 5 years

Interventions

GENETICMolecular monitoring by quantification of cell-free DNA

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.