Clinical trial Recruiting at 7 sites Interventional Ages 18 and up

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.

More Immunotherapy trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorUniversity Hospital, Strasbourg, France
Academic / other
Drugs / interventionsimmunotherapy
Locations8 sites (Besançon and 7 other locations)
StatusRecruiting
StartedMay 27, 2021
Main results expectedMay 27, 2025
Study endsOctober 27, 2027
Registry record updatedNovember 23, 2022
Trial IDNCT04720339 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

  • 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
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, France
    Recruiting
  • CLCC Georges-François Leclerc
    Dijon, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.