Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
REBIMMUNE
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Aug 2020
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
August 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
September 3, 2025
March 1, 2025
7 years
March 2, 2020
September 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At the end of study, up to 2 years
Study Arms (1)
Rebiopsy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient under guardianship or curatorship;
- Unable to provide written informed consent for the study;
- Technical impossibility to carry out tissular rebiopsy under local anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92100, France
Related Publications (1)
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.
PMID: 28407528BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etienne Giroux Leprieur, MD, PhD
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 9, 2020
Study Start
August 18, 2020
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
September 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share