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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720339
• Other study ID #: 7652
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• IMMUNOTHERAPY
• NSCLC
• QUANTIFICATION OF CELL-FREE DNA

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	Vandœuvre-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)