Non Small Cell Lung Cancer, NSCLC
Conditions
Brief summary
The incorporation of PD-L1 testing into clinical practice has progressed at a rapid pace, and now offers an additional line of therapy for eligible patients with nonsmall cell lung cancer. The assay used to detect circulating levels of PD-L1 currently requires core biopsies, and is not approved to be used for specimens collected through a needle based cytological technique. Though endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) has markedly improved the manner in which patients are diagnosed and staged for lung cancer, alternative means of tissue collection may be mandatory to offer patients access to newer lines of therapy such as PD-L1 inhibition. EBUS-miniforceps biopsy may allow bronchoscopists to obtain core biopsy specimens through the technique of endobronchial ultrasound, so that more invasive approaches such as surgery may be avoided. Feasibility using this approach would indicate that all patients being staged with endobronchial ultrasound procedures would be candidates for PD-L1 testing and potential therapy. This study is proposed to evaluate the feasibility of using endobronchial ultrasound guided miniforceps biopsy (EBUS-MFB) to acquire tissue that is adequate for PD-L1 testing. Feasibility in this study is defined as the ability to obtain adequate material during EBUS procedures to perform PD-L1 testing.
Interventions
DEVICECoreDx Pulmonary Mini-Forceps
Manufactured by Boston Scientific
Sponsors
Boston Scientific Corporation
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with central lung lesion 1cm in size or larger identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. * Are at least 18 years old * Are able to provide informed consent * Are not pregnant as confirmed by bHCG testing prior to procedure
Exclusion criteria
* Patients who refuse to participate * Are less than 18 years of age * Are pregnant * Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist * Are unable to provide informed consent * Are on anticoagulant medications and who cannot safely discontinue their medication prior to their procedure at the recommendation of their treating physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired | Completion of biopsy (day 1) | * Adequacy will be defined as sufficient core biopsy material to perform the PD-L1 assay specific for nivolumab * Any specimen in which the requested assay returns as insufficient material to perform testing will be deemed an inadequate specimen. * Feasibility cannot be determined until the completion of biopsy for all patients enrolled |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Adverse Events | Through 24 hours after biopsy procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endobronchial Ultrasound Guided Miniforceps Biopsy * Standard of care convex-probe endobronchial ultrasound and transbronchial needle aspiration followed by rapid on-site evaluation. If evaluation yields a diagnosis of nonsmall cell lung cancer then EBUS-MFB will be performed.
* With the EBUS bronchoscope, 6 needle punctures will be made into the targeted lymph node with the 22 gauge aspiration needle. The needle will be removed and the 1mm miniforceps will be passed through the working channel of the EBUS-bronchoscope into the targeted lymph node through the puncture site made using the 22 gauge needle using continuous endobronchial ultrasound guidance. The miniforceps will be used to obtain a core biopsy of the targeted lymph node - 8 core biopsies will be obtained from each targeted lymph node using this technique | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Endobronchial Ultrasound Guided Miniforceps Biopsy |
|---|---|
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired
* Adequacy will be defined as sufficient core biopsy material to perform the PD-L1 assay specific for nivolumab * Any specimen in which the requested assay returns as insufficient material to perform testing will be deemed an inadequate specimen. * Feasibility cannot be determined until the completion of biopsy for all patients enrolled
Time frame: Completion of biopsy (day 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endobronchial Ultrasound Guided Miniforceps Biopsy | Feasibility of Utilizing Endobronchial Ultrasound Guided Miniforceps as Assessed by the Number of Participants From Whom Adequate Amounts of Tissue to Perform PD-L1 Testing Was Acquired | 13 Participants |
Secondary
Rate of Adverse Events
Time frame: Through 24 hours after biopsy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endobronchial Ultrasound Guided Miniforceps Biopsy | Rate of Adverse Events | 0 Participants |