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Clinical Trial NCT04720339 for NSCLC, IMMUNOTHERAPY, QUANTIFICATION OF CELL-FREE DNA is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy. 250 Immunotherapy Biomarker-Driven

Recruiting
Clinical Trial NCT04720339 is an interventional study for NSCLC, IMMUNOTHERAPY, QUANTIFICATION OF CELL-FREE DNA that is recruiting. It started on May 27, 2021 with plans to enroll 250 participants. Led by University Hospital, Strasbourg, France, it is expected to complete by October 27, 2027. The latest data from ClinicalTrials.gov was last updated on November 23, 2022.
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 pr...

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Official Title

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

Conditions
NSCLCIMMUNOTHERAPYQUANTIFICATION OF CELL-FREE DNA
Other Study IDs
  • 7652
NCT ID Number
NCT04720339
Start Date (Actual)
2021-05-27
Last Update Posted
2022-11-23
Completion Date (Estimated)
2027-10-27
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
NSCLC
Cell-free DNA
Immunotherapy
Digital PCR
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental arm
Molecular monitoring by quantification of cell-free DNA
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 pr...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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 earlier quantification of cell-free DNA corresponds to the variation from the time at inclusion and the time before the second administration of immunotherapy.
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • concomitant other type of cancer
  • another cancer in the last 5 years
University Hospital, Strasbourg, France logoUniversity Hospital, Strasbourg, France
Study Central Contact
Contact: BEAU-FALLER Michele, MD, +33 3 88 12 84 57, [email protected]
8 Study Locations in 1 Countries
CHU de Besancon - Service de pneumologie, Besançon, France
WESTEEL Virginie, MD, Contact, +33 3 81 66 81 66, [email protected]
Virginie WESTEEL, MD, Principal Investigator
Julie MORACCHINI, MD, Sub-Investigator
Marie GAINET-BRUN, MD, Sub-Investigator
Pascale JACOULET, MD, Sub-Investigator
Olivier ADOTEVI, MD, Sub-Investigator
Guillaume EBERST, MD, Sub-Investigator
Emeline ORILLARD, MD, Sub-Investigator
Hamadi ALMOTLAK, MD, Sub-Investigator
Recruiting
Hopitaux Civils de Colmar - service de Pneumologie, Colmar, France
MOREAU Lionel, MD, Contact, +33 3 89 12 40 00, [email protected]
Lionel MOREAU, MD, Principal Investigator
Anne Catherine NEIDHARDT, MD, Sub-Investigator
Jean-Philippe OSTER, MD, Sub-Investigator
Recruiting
CHU de Dijon - service de Pneumologie, Dijon, France
FOUCHER Pascal, MD, Contact, +33 3 80 29 30 31, [email protected]
Pascal FOUCHER, MD, Principal Investigator
Astrid MERCIER, MD, Sub-Investigator
Chems Eddine NESSAIBIA, MD, Sub-Investigator
Fleur-Marie QUILOT, MD, Sub-Investigator
Ayoub ZOUAK, MD, Sub-Investigator
Recruiting
CLCC Georges-François Leclerc, Dijon, France
KADERBHAI Courèche, MD, Contact, +33 3 80 73 75 28, [email protected]
KADERBHAI Courèche, MD, Principal Investigator
Not yet recruiting
GHR Mulhouse Sud-Alsace - Service de Pneumologie, Mulhouse, France
DEBIEUVRE Didier, MD, Contact, +33 03 89 64 73 96, [email protected]
Didier DEBIEUVRE, MD, Principal Investigator
Mathieu FORE, MD, Sub-Investigator
Anthony GSCHWEND, MD, Sub-Investigator
Emilie FOCH, MD, Sub-Investigator
Recruiting
CHU de Reims - service de Pneumologie, Reims, France
DEWOLF Maxime, MD, Contact, +33 3 26 78 78 78, [email protected]
Maxime DEWOLF, MD, Principal Investigator
Gaëtan DESLEE, MD, Sub-Investigator
Julien ANCEL, MD, Sub-Investigator
Antoine DUMAZET, MD, Sub-Investigator
Recruiting
CHRU de Strasbourg, Strasbourg, France
BEAU-FALLER Michele, MD, Contact, +33 388128457, [email protected]
MASCAUX Céline, MD, Contact, +33 369550195, [email protected]
BEAU-FALLER Michele, MD, Principal Investigator
PAMART Guillaume, MD, Sub-Investigator
MATAU César, MD, Sub-Investigator
PABST Lucile, MD, Sub-Investigator
MENNECIER Bertrand, MD PhD, Sub-Investigator
COSSART Adrien, MD, Sub-Investigator
STENGER Rodolphe, MD, Sub-Investigator
MASCAUX Céline, MD PhD, Sub-Investigator
Recruiting
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France
CLEMENT-DUCHENE Christelle, MD, Contact, +33 3 83 59 83 31, [email protected]
Christelle CLEMENT-DUCHENE, MD, Principal Investigator
Lionel UWER, MD, Sub-Investigator
Recruiting