Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2019-08-20

Brief Summary

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This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted through the nose or mouth to view the inside of the trachea, air passages, and lungs. Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid. Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that are more present in some cancers than others that will help determine which individuals have a greater or lesser chance of benefiting from immunotherapy.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.

SECONDARY OBJECTIVES:

I. To determine biomarkers that may be predictive of treatment related adverse events, specifically pneumonitis.

II. To further elucidate lung immunologic microenvironment by performing single cell analysis in addition to mass cytometry (Cytof) on cells of bronchoalveolar lavage.

OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes.

After completion of study, patients are followed up at 3, 6, 12, and 24 months.

Conditions

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Non-Small Cell Lung Carcinoma Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Bronchoscopy with bronchoalveolar lavage

Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes

Group Type EXPERIMENTAL

Bronchoscopy with Bronchoalveolar Lavage

Intervention Type PROCEDURE

Undergo bronchoscopy with bronchoalveolar lavage

Laboratory Biomarker Analysis

Intervention Type OTHER

Laboratory Biomarker Analysis

Interventions

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Bronchoscopy with Bronchoalveolar Lavage

Undergo bronchoscopy with bronchoalveolar lavage

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
* Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI as any line of chemotherapy is acceptable) as deemed by individual's treating oncologist

Exclusion Criteria

* Coagulopathy with international normalized ratio (INR) \> 2.0 or
* Coagulopathy with platelets (Plt) \< 10 k
* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications
* Respiratory failure requiring greater than 6 Lpm supplemental oxygen (O2) by nasal cannula or mechanical ventilation within the past six weeks
* Inability to perform informed consent due to any medical or psychiatric condition

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No