NCT02937402

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

October 14, 2016

Last Update Submit

September 5, 2019

Conditions

Non-Small Cell Lung CarcinomaSmall Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria

    Up to 24 months

Study Arms (1)

Bronchoscopy with bronchoalveolar lavage

EXPERIMENTAL

Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes

Procedure: Bronchoscopy with Bronchoalveolar LavageOther: Laboratory Biomarker Analysis

Interventions

Bronchoscopy with Bronchoalveolar LavagePROCEDURE

Undergo bronchoscopy with bronchoalveolar lavage

Bronchoscopy with bronchoalveolar lavage
Laboratory Biomarker AnalysisOTHER

Laboratory Biomarker Analysis

Bronchoscopy with bronchoalveolar lavage

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Fabien Maldonado, M.D.

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

April 5, 2018

Primary Completion

July 8, 2019

Study Completion

August 20, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

US(1)