Lung CancerREBIMMUNENCT04300062
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
A study testing Rebiopsy in people with Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Rebiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2020to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient under guardianship or curatorship;
- Unable to provide written informed consent for the study;
- Technical impossibility to carry out tissular rebiopsy under local anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92100
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Rebiopsy
- Keywords
- lung cancer, rebiopsy, immunotherapy, progression
- Medical subject headings
- Lung Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Rebiopsy | Experimental | Not described Receives: Procedure: Rebiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start18 Aug 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Giroux Leprieur, MD, PhD, Principal investigator, Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300062
- Sponsor's protocol ID
- APHP200398
- Acronym
- REBIMMUNE
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2020
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28407528
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT04300062
- Acronym / sponsor ID
- REBIMMUNE / APHP200398
- Conditions
- Lung Cancer
- Keywords
- lung cancer, rebiopsy, immunotherapy, progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebiopsy | Experimental | Procedure: Rebiopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship;
- Unable to provide written informed consent for the study;
- Technical impossibility to carry out tissular rebiopsy under local anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebiopsyBiopsy 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. | Procedure or surgery | Rebiopsy |
Primary outcome
Incidence of specific histomolecular resistance
Time frame: At the end of study, up to 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 28407528Giroux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etienne Giroux Leprieur, MD, PhD principal investigator
Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebiopsy in people with Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etienne Giroux Leprieur, MD, PhD (+33 1 49 09 58 02, etienne.giroux-leprieur@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of specific histomolecular resistance (time frame: At the end of study, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.