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

Not Applicable

Recruiting

• Conditions: IMMUNOTHERAPY; QUANTIFICATION OF CELL-FREE DNA; NSCLC
• Interventions: Genetic: Molecular monitoring by quantification of cell-free DNA

• Registration Number: NCT04720339
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-05-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-23
• Primary Completion: 2025-05-27
• Study Completion: 2027-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Molecular monitoring by quantification of cell-free DNA	-

Primary Outcome Measures

Name	Time	Method
Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit	Inclusion visit - visit 2 (day 60)	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.

Secondary Outcome Measures

Name	Time	Method
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.	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)	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.

Trial Locations

Locations (8)

GHR Mulhouse Sud-Alsace - Service de Pneumologie; 🇫🇷 Mulhouse, France

CHU de Reims - service de Pneumologie; 🇫🇷 Reims, France

Hopitaux Civils de Colmar - service de Pneumologie; 🇫🇷 Colmar, France

CHU de Dijon - service de Pneumologie; 🇫🇷 Dijon, France

CLCC Georges-François Leclerc; 🇫🇷 Dijon, France

CHU de Besancon - Service de pneumologie; 🇫🇷 Besançon, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France