Monitoring cell-free DNA in lung cancer patients receiving immunotherapy
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Besançon and 7 other locations) |
| Trial ID | NCT04720339 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage IIIA, IIIB, or IV non-small cell lung cancer who are undergoing immunotherapy.
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.
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 performed: Other studies have shown promise in using cfDNA as a biomarker in cancer treatment, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Besançon and 7 other locations
- 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)
Study contacts
- Study coordinator: BEAU-FALLER Michele, MD
- Email: michele.beau@chru-strasbourg.fr
- Phone: +33 3 88 12 84 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.