NCT04159025

EBUS-Miniforceps Biopsy Specimen Acquisition for PD-L1 Testing in Nonsmall Cell Lung Cancer

Completed NA Results posted Last updated 1 March 2023

What this trial tests

NA trial testing CoreDx Pulmonary Mini-Forceps in Non Small Cell Lung Cancer in 20 participants. Completed in 25 February 2022.

Timeline

8 January 2020

Primary endpoint
24 February 2022

25 February 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	8 January 2020
Primary completion	24 February 2022
Estimated completion	25 February 2022
Sites	1 location across United States

Drugs / interventions tested

• CoreDx Pulmonary Mini-Forceps

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• NSCLC — all drugs for NSCLC →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer or NSCLC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

Group	Value	95% CI
Endobronchial Ultrasound Guided Miniforceps Biopsy	13

Rate of Adverse Events Secondary · Through 24 hours after biopsy procedure

Group	Value	95% CI
Endobronchial Ultrasound Guided Miniforceps Biopsy	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.