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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04720339
Other study ID # 7652
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 27, 2021
Est. completion date October 27, 2027

Study information

Verified date November 2022
Source University Hospital, Strasbourg, France
Contact BEAU-FALLER Michele, MD
Phone +33 3 88 12 84 57
Email michele.beau@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 27, 2027
Est. primary completion date May 27, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Genetic:
Molecular 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.

Locations

Country Name City State
France 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 VandÅ“uvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive 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.
Inclusion visit - visit 2 (day 60)
Secondary 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.
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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