ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS)

NCT05117372 | Unknown

• 1 other identifier: 2020-A01626-33
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies

  1 day

Study Arms (2)

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

ACTIVE COMPARATOR

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

Other: treatment with immunotherapy and diffuse infiltrative lung disease

Patients not treated with immunotherapy and requiring carcinologic lobectomy

PLACEBO COMPARATOR

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

Other: Patients requiring carcinologic lobectomy

Interventions

treatment with immunotherapy and diffuse infiltrative lung disease OTHER

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

Patients treated with with immunotherapy and developing diffuse infiltrative lung disease

Patients requiring carcinologic lobectomy OTHER

Patients requiring carcinologic lobectomy

Patients not treated with immunotherapy and requiring carcinologic lobectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Therapeutics; Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy

Central Study Contacts

Jérôme LE PAVEC, MD

CONTACT

01.40.94.24.30; J.lepavec@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: November 11, 2021
• Study Start: February 17, 2021
• Primary Completion: August 17, 2022
• Study Completion: February 17, 2024
• Last Updated: November 11, 2021

Record last verified: 2021-08

Locations

FR (1)