Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer (REBIMMUNE)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rebiopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, rebiopsy, immunotherapy, progression
Eligibility Criteria
Inclusion Criteria:
- Diagnosed NSCLC or SCLC;
- Patient treated priorly by ICI and progressed under ICI;
- Have provided written informed consent for the study;
- Be >/= 18 years of age on day of signing informed consent.
Exclusion Criteria:
- Patient under guardianship or curatorship;
- Unable to provide written informed consent for the study;
- Technical impossibility to carry out tissular rebiopsy under local anesthesia.
Sites / Locations
- Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHPRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rebiopsy
Arm Description
Outcomes
Primary Outcome Measures
Incidence of specific histomolecular resistance
Banking of tumor samples at progression with immune checkpoint inhibitor (ICI) in lung cancer, to evaluate the incidence of specific histomolecular resistance mechanisms to ICI by immunohistochemistry and molecular testing.
Secondary Outcome Measures
Full Information
NCT ID
NCT04300062
First Posted
March 2, 2020
Last Updated
March 14, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04300062
Brief Title
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
Acronym
REBIMMUNE
Official Title
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI.
The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.
Detailed Description
The study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of Ambroise Paré hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, rebiopsy, immunotherapy, progression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rebiopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rebiopsy
Intervention Description
Biopsy will be carry out with flexible bronchoscopy as usual practice under local anesthesia: under endobronchial ultrasound, punction under CT scan or ultrasonography, percutaneous pleural puncturing.
Primary Outcome Measure Information:
Title
Incidence of specific histomolecular resistance
Description
Banking of tumor samples at progression with immune checkpoint inhibitor (ICI) in lung cancer, to evaluate the incidence of specific histomolecular resistance mechanisms to ICI by immunohistochemistry and molecular testing.
Time Frame
At the end of study, up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed NSCLC or SCLC;
Patient treated priorly by ICI and progressed under ICI;
Have provided written informed consent for the study;
Be >/= 18 years of age on day of signing informed consent.
Exclusion Criteria:
Patient under guardianship or curatorship;
Unable to provide written informed consent for the study;
Technical impossibility to carry out tissular rebiopsy under local anesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne Giroux Leprieur, MD, PhD
Phone
+33 1 49 09 58 02
Email
etienne.giroux-leprieur@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Giroux Leprieur, MD, PhD
Organizational Affiliation
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28407528
Citation
Giroux Leprieur E, Dumenil C, Julie C, Giraud V, Dumoulin J, Labrune S, Chinet T. Immunotherapy revolutionises non-small-cell lung cancer therapy: Results, perspectives and new challenges. Eur J Cancer. 2017 Jun;78:16-23. doi: 10.1016/j.ejca.2016.12.041. Epub 2017 Apr 11.
Results Reference
background
Learn more about this trial
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
We'll reach out to this number within 24 hrs