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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: treatment with immunotherapy and diffuse infiltrative lung disease; Other: Patients requiring carcinologic lobectomy

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme LE PAVEC, MD; Phone Number: 01.40.94.24.30; Email: J.lepavec@ghpsj.fr

Study Locations

• France
  • Le Plessis Robinson, France, 92350
    • Recruiting
    • Centre chirurgical Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: treatment with immunotherapy and diffuse infiltrative lung disease; Patients treated with with immunotherapy and developing diffuse infiltrative lung disease
Placebo Comparator: Patients not treated with immunotherapy and requiring carcinologic lobectomy; Group 2: Patients with lung cancer not treated with immunotherapy and requiring carcinologic lobectomy	Other: Patients requiring carcinologic lobectomy; Patients requiring carcinologic lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expression levels of cellular and soluble actors involved in the occurrence of pulmonary toxicities associated with antitumor immunotherapies	1 day

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): August 17, 2022
• Study Completion (Anticipated): February 17, 2024

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: anti PD-(L)1; Diffuse infiltrative lung disease
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2020-A01626-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No