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

NCT04720339 | Recruiting

• 1 other identifier: 7652
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 8

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.

Conditions

NSCLC; IMMUNOTHERAPY; QUANTIFICATION OF CELL-FREE DNA

Keywords

NSCLC; Cell-free DNA; Immunotherapy; Digital PCR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Experimental arm

EXPERIMENTAL

Genetic: Molecular monitoring by quantification of cell-free DNA

Interventions

Molecular monitoring by quantification of cell-free DNA GENETIC

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (8)

CHU de Besancon - Service de pneumologie

Besançon, France

RECRUITING

Hopitaux Civils de Colmar - service de Pneumologie

Colmar, France

RECRUITING

CHU de Dijon - service de Pneumologie

Dijon, France

RECRUITING

CLCC Georges-François Leclerc

Dijon, France

NOT YET RECRUITING

GHR Mulhouse Sud-Alsace - Service de Pneumologie

Mulhouse, France

RECRUITING

CHU de Reims - service de Pneumologie

Reims, France

RECRUITING

CHRU de Strasbourg

Strasbourg, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

RECRUITING

Central Study Contacts

BEAU-FALLER Michele, MD

CONTACT

+33 3 88 12 84 57; michele.beau@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: January 22, 2021
• Study Start: May 27, 2021
• Primary Completion: May 27, 2025
• Study Completion (Estimated): October 27, 2027
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)