ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

Study Overview
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Brief Summary
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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.

Official Title
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ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: treatment with immunotherapy and diffuse infiltrative lung disease
* Other: Patients requiring carcinologic lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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 Exclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients treated with with immunotherapy and developing diffuse infiltrative lung disease<br>Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease | Other: treatment with immunotherapy and diffuse infiltrative lung disease<br>* Patients treated with with immunotherapy and developing diffuse infiltrative lung disease<br>|
| Placebo Comparator: Patients not treated with immunotherapy and requiring carcinologic lobectomy<br>Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy | Other: Patients requiring carcinologic lobectomy<br>* Patients requiring carcinologic lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti PD-(L)1, Diffuse infiltrative lung disease