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ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05117372
Acronym
LBA-PI
Enrollment
34
Registered
2021-11-11
Start date
2021-02-17
Completion date
2024-02-17
Last updated
2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

anti PD-(L)1, Diffuse infiltrative lung disease

Brief 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. 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.

Interventions

OTHERtreatment with immunotherapy and diffuse infiltrative lung disease

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

OTHERPatients requiring carcinologic lobectomy

Patients requiring carcinologic lobectomy

Sponsors

Centre Chirurgical Marie Lannelongue
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies1 day

Countries

France

Contacts

Primary ContactJérôme LE PAVEC, MD
J.lepavec@ghpsj.fr01.40.94.24.30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026