Lung CancerLBA-PINCT05117372
ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)
A study testing treatment with immunotherapy and diffuse infiltrative lung disease and Patients requiring carcinologic lobectomy in people with Lung Cancer, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies. 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?
- treatment with immunotherapy and diffuse infiltrative lung disease and Patients requiring carcinologic lobectomy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2021to 17 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult subject (≥ 18 years old)
- Patient having consented to the research
- Group 1:
- Patient with cancer who was treated with immunotherapy
- Appearance of CT lung abnormalities during immunotherapy, not related to cancer
- With high suspicion of infiltrative lung disease:
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- Pneumopathy (CTCAE version 5 classification).
- Patients requiring bronchial fibroscopy with BAL
- Groups 2:
- Patient with lung cancer with peripheral tumor
- Requires surgical pulmonary lobectomy in the operating room
Who cannot join
- Patient treated or having been treated in the last 2 months with corticosteroid therapy
- Patient treated with immunosuppressant and/or cyclophosphamide, and/or Anti-TNF α in the last 12 months
- Absence of consent
- Patient under curatorship, guardianship or safeguard of justice
- Pregnant woman
- Group 1:
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- Patient with respiratory failure
- Groups 2:
- Patient with lung cancer with proximal or endobronchial tumor
- Patients requiring bilobectomy or pneumonectomy
- Patient who has been treated with immunotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
About this study
Official title: ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.
The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.
Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.
- Conditions
- Lung Cancer
- Being tested
- treatment with immunotherapy and diffuse infiltrative lung disease, Patients requiring carcinologic lobectomy
- Keywords
- anti PD-(L)1, Diffuse infiltrative lung disease
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with immunotherapy and diffuse infiltrative lung diseaseOther
Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
Patients requiring carcinologic lobectomyOther
Patients requiring carcinologic lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with with immunotherapy and developing diffuse infiltrative lung disease | Active comparator | Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease Receives: Other: treatment with immunotherapy and diffuse infiltrative lung disease |
| Patients not treated with immunotherapy and requiring carcinologic lobectomy | Placebo comparator | Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy Receives: Other: Patients requiring carcinologic lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start17 Feb 2021
- Primary completion17 Aug 2022 (estimated)
- Study completion17 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117372
- Sponsor's protocol ID
- 2020-A01626-33
- Acronym
- LBA-PI
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES
- ClinicalTrials.gov ID
- NCT05117372
- Acronym / sponsor ID
- LBA-PI / 2020-A01626-33
- Conditions
- Lung Cancer
- Keywords
- anti PD-(L)1, Diffuse infiltrative lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 17 Feb 2024 (estimated)
- First posted
- 11 Nov 2021 (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.
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.
The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.
Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with with immunotherapy and developing diffuse infiltrative lung disease | Active comparator | Other: treatment with immunotherapy and diffuse infiltrative lung diseaseGroup 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease |
| Patients not treated with immunotherapy and requiring carcinologic lobectomy | Placebo comparator | Other: Patients requiring carcinologic lobectomyGroup 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult subject (≥ 18 years old)
- Patient having consented to the research
- Patient with cancer who was treated with immunotherapy
- Appearance of CT lung abnormalities during immunotherapy, not related to cancer
- With high suspicion of infiltrative lung disease:
Key exclusion criteria (11 listed)
- Patient treated or having been treated in the last 2 months with corticosteroid therapy
- Patient treated with immunosuppressant and/or cyclophosphamide, and/or Anti-TNF α in the last 12 months
- Absence of consent
- Patient under curatorship, guardianship or safeguard of justice
- Pregnant woman
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 |
|---|---|---|
| treatment with immunotherapy and diffuse infiltrative lung diseasePatients treated with with immunotherapy and developing diffuse infiltrative lung disease | Other | Patients treated with with immunotherapy and developing diffuse infiltrative lung disease |
| Patients requiring carcinologic lobectomyPatients requiring carcinologic lobectomy | Other | Patients not treated with immunotherapy and requiring carcinologic lobectomy |
Primary outcome
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with immunotherapy and diffuse infiltrative lung disease and Patients requiring carcinologic lobectomy in people with Lung Cancer, run by Centre Chirurgical Marie Lannelongue 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme LE PAVEC, MD (01.40.94.24.30, J.lepavec@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2021.