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

November 18, 2022 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU de Besançon - Service de Pneumologie
        • Contact:
        • Principal Investigator:
          • Virginie Westeel, MD
        • Sub-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
      • Colmar, France
        • Recruiting
        • Hopitaux Civils de Colmar - service de Pneumologie
        • Contact:
        • Principal Investigator:
          • Lionel MOREAU, MD
        • Sub-Investigator:
          • Anne Catherine NEIDHARDT, MD
        • Sub-Investigator:
          • Jean-Philippe OSTER, MD
      • Dijon, France
        • Recruiting
        • CHU de Dijon - service de Pneumologie
        • Contact:
        • Principal Investigator:
          • PASCAL FOUCHER, MD
        • Sub-Investigator:
          • Astrid MERCIER, MD
        • Sub-Investigator:
          • Chems Eddine NESSAIBIA, MD
        • Sub-Investigator:
          • Fleur-Marie QUILOT, MD
        • Sub-Investigator:
          • Ayoub ZOUAK, MD
      • Dijon, France
        • Not yet recruiting
        • CLCC Georges-François Leclerc
        • Contact:
        • Principal Investigator:
          • KADERBHAI Courèche, MD
      • Mulhouse, France
        • Recruiting
        • GHR Mulhouse Sud-Alsace - Service de Pneumologie
        • Contact:
        • Principal Investigator:
          • Didier Debieuvre, MD
        • Sub-Investigator:
          • Mathieu FORE, MD
        • Sub-Investigator:
          • Anthony GSCHWEND, MD
        • Sub-Investigator:
          • Emilie FOCH, MD
      • Reims, France
        • Recruiting
        • CHU de Reims - service de Pneumologie
        • Contact:
        • Principal Investigator:
          • Maxime DEWOLF, MD
        • Sub-Investigator:
          • Gaëtan DESLEE, MD
        • Sub-Investigator:
          • Julien ANCEL, MD
        • Sub-Investigator:
          • Antoine DUMAZET, MD
      • Strasbourg, France
        • Recruiting
        • CHRU de Strasbourg
        • Contact:
        • Contact:
        • Principal Investigator:
          • BEAU-FALLER Michele, MD
        • Sub-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
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
        • Principal Investigator:
          • Christelle CLEMENT-DUCHENE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Genetic: 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 previously routinely identified in tumor tissue) by ddPCR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit
Time Frame: Inclusion visit - visit 2 (day 60)

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 Measure
Measure Description
Time 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.
Time Frame: 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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2021

Primary Completion (Anticipated)

May 27, 2025

Study Completion (Anticipated)

October 27, 2027

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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