Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

Lung Cancer Clinical Trial

— REBIMMUNE  

Official title:

Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300062
• Other study ID #: 2020-A00035-34
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Etienne Giroux Leprieur, MD, PhD
• Phone: +33 1 49 09 58 02
• Email: etienne.giroux-leprieur[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Rebiopsy
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.

Locations

Country	Name	City	State
France	Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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