Non-Small Cell Lung CarcinomaNCT02937402
Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer
A study testing Bronchoscopy with Bronchoalveolar Lavage and Laboratory Biomarker Analysis in people with Non-Small Cell Lung Carcinoma and Small Cell Lung Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma
- What is being tested?
- Bronchoscopy with Bronchoalveolar Lavage and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Bronchoscopy with Bronchoalveolar Lavage, Laboratory Biomarker Analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with Bronchoalveolar LavageProcedure or surgery
Undergo bronchoscopy with bronchoalveolar lavage
Laboratory Biomarker AnalysisOther
Laboratory Biomarker Analysis
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy with bronchoalveolar lavage | Experimental | Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start5 Apr 2018
- Primary completion8 Jul 2019
- Study completion20 Aug 2019
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, M.D., Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937402
- Sponsor's protocol ID
- VICC THO 16108
- Other IDs
- NCI-2016-01469
- Status last verified
- Sep 2019
- First submitted
- 14 Oct 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response to Immune Checkpoint Inhibitors in Non-small Cell and Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02937402
- Acronym / sponsor ID
- VICC THO 16108
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy with bronchoalveolar lavage | Experimental | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Other: Laboratory Biomarker AnalysisPatients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy with Bronchoalveolar LavageUndergo bronchoscopy with bronchoalveolar lavage | Procedure or surgery | Bronchoscopy with bronchoalveolar lavage |
| Laboratory Biomarker AnalysisLaboratory Biomarker Analysis | Other | Bronchoscopy with bronchoalveolar lavage |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Maldonado, M.D. principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy with Bronchoalveolar Lavage and Laboratory Biomarker Analysis in people with Non-Small Cell Lung Carcinoma and Small Cell Lung Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.