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

  • STATUS
    Recruiting
  • End date
    Oct 27, 2025
  • participants needed
    250
  • sponsor
    University Hospital, Strasbourg, France
Updated on 12 June 2021
progressive disease
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer, Immunotherapy, immunotherapies, nsclc, QUANTIFICATION OF CELL-FREE DNA, QUANTIFICATION OF CELL-FREE DNA
Treatment Molecular monitoring by quantification of cell-free DNA
Clinical Study IdentifierNCT04720339
SponsorUniversity Hospital, Strasbourg, France
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

age over 18
informed of the objectives of the project and signed consent
non small cell lung cancer, stage IIIB to IV
PS <1
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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