ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) (LBA-PI)

Centre Chirurgical Marie Lannelongue

Status: Unknown

Conditions: Lung Cancer

Treatments: Other: Patients requiring carcinologic lobectomy; Other: treatment with immunotherapy and diffuse infiltrative lung disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05117372

2020-A01626-33

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups, including a placebo group

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

Active Comparator group

Description:

Group 1: Patients treated for cancer with immunotherapy and developing diffuse infiltrative lung disease

Treatment:

Other: treatment with immunotherapy and diffuse infiltrative lung disease

Patients not treated with immunotherapy and requiring carcinologic lobectomy

Placebo Comparator group

Description:

Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy

Treatment:

Other: Patients requiring carcinologic lobectomy