Clinical trial NCT04720339: Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Official title: Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NSCLC
IMMUNOTHERAPY
QUANTIFICATION OF CELL-FREE DNA
Keywords: NSCLC
Cell-free DNA
Immunotherapy
Digital PCR
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: 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

Primary outcomes:
measure: Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit
timeFrame: Inclusion visit - visit 2 (day 60)
Secondary outcomes:
measure: 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.
timeFrame: 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)
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besancon - Service de pneumologie
city: Colmar
country: France
facility: Hopitaux Civils de Colmar - service de Pneumologie
city: Dijon
country: France
facility: CHU de Dijon - service de Pneumologie
city: Dijon
country: France
facility: CLCC Georges-François Leclerc
city: Mulhouse
country: France
facility: GHR Mulhouse Sud-Alsace - Service de Pneumologie
city: Reims
country: France
facility: CHU de Reims - service de Pneumologie
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
References: