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

Predictors of Response to Immune Checkpoint Inhibitors in Non-small Cell and Small Cell Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Carcinoma; Non-Small Cell Lung Carcinoma
• Intervention / Treatment: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Laboratory Biomarker Analysis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronchoscopy with bronchoalveolar lavage; Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes	Procedure: Bronchoscopy with Bronchoalveolar Lavage; Undergo bronchoscopy with bronchoalveolar lavage; Other: Laboratory Biomarker Analysis; Laboratory Biomarker Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria	Up to 24 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Fabien Maldonado, M.D., Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: VICC THO 16108; NCI-2016-01469 (Registry Identifier: NCI, Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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