Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bronchoscopy with Bronchoalveolar Lavage
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Small Cell Lung Carcinoma
Eligibility Criteria
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
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bronchoscopy with bronchoalveolar lavage
Arm Description
Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes
Outcomes
Primary Outcome Measures
Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT02937402
First Posted
October 14, 2016
Last Updated
September 5, 2019
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02937402
Brief Title
Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer
Official Title
Predictors of Response to Immune Checkpoint Inhibitors in Non-small Cell and Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bronchoscopy with bronchoalveolar lavage
Arm Type
Experimental
Arm Description
Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy with Bronchoalveolar Lavage
Intervention Description
Undergo bronchoscopy with bronchoalveolar lavage
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Laboratory Biomarker Analysis
Primary Outcome Measure Information:
Title
Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Maldonado, M.D.
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer
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