Monitoring cell-free DNA in lung cancer patients receiving immunotherapy
Official title: Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Run by University Hospital, Strasbourg, France · NCT04720339 · Data updated 2026-11-12
This study is testing if measuring cell-free DNA in lung cancer patients receiving immunotherapy can help predict how well the treatment is working.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Besançon and 7 other locations) |
| Status | Recruiting |
| Started | May 27, 2021 |
| Main results expected | May 27, 2025 |
| Study ends | October 27, 2027 |
| Registry record updated | November 23, 2022 |
| Trial ID | NCT04720339 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with stage IIIA, IIIB, or IV non-small cell lung cancer who are undergoing immunotherapy.
✕Probably not a fit
Patients with other concurrent cancers or those who have had another cancer in the last 5 years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to monitor non-small cell lung cancer (NSCLC) patients undergoing immunotherapy by quantifying cell-free DNA (cfDNA) through digital PCR. The primary goal is to evaluate the predictive value of cfDNA levels at the first reevaluation for clinical benefit. Additionally, the study will assess the early predictive value of cfDNA quantification before the second immunotherapy treatment and its correlation with disease progression. This longitudinal approach seeks to establish a robust biomarker for NSCLC treatment outcomes.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for predicting treatment response in NSCLC patients receiving immunotherapy.
How similar studies have gone: Other studies have shown promise in using cfDNA as a biomarker in cancer treatment, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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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 -
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
Show 2 more locations
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Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France Recruiting -
CLCC Georges-François Leclerc
Dijon, France Not yet recruiting
Study contacts
- Study coordinator: BEAU-FALLER Michele, MD
- Email: michele.beau@chru-strasbourg.fr
- Phone: +33 3 88 12 84 57
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.