ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

Lung Cancer Clinical Trial

— LBA-PI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117372
• Other study ID #: 2020-A01626-33
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: February 17, 2024

Study information

• Verified date: August 2021
• Source: Centre Chirurgical Marie Lannelongue
• Contact: Jérôme LE PAVEC, MD
• Phone: 01.40.94.24.30
• Email: J.lepavec[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: February 17, 2024
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a 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

Related Conditions & MeSH terms

• Inflammation
• Lung Cancer

Intervention

Other:
• treatment with immunotherapy and diffuse infiltrative lung disease
Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
• Patients requiring carcinologic lobectomy
Patients requiring carcinologic lobectomy

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies		1 day