ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

NCT ID: NCT05117372

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2024-02-17

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.

Conditions

Lung Cancer

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

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

Group Type: ACTIVE_COMPARATOR

treatment with immunotherapy and diffuse infiltrative lung disease

Intervention Type: OTHER

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

Patients not treated with immunotherapy and requiring carcinologic lobectomy

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

Group Type: PLACEBO_COMPARATOR

Patients requiring carcinologic lobectomy

Intervention Type: OTHER

Patients requiring carcinologic lobectomy

Interventions

treatment with immunotherapy and diffuse infiltrative lung disease

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

Intervention Type: OTHER

Patients requiring carcinologic lobectomy

Patients requiring carcinologic lobectomy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jérôme LE PAVEC, MD

Role: CONTACT

Phone: 01.40.94.24.30

Email: J.lepavec@ghpsj.fr

Other Identifiers

2020-A01626-33

Identifier Type: -

Identifier Source: org_study_id