BEACON-LUNG – Biomarker analysis in high PD-L1 expressing NSCLC patients

Mary Jo Fidler, MD
Rush University Medical Center

The BEACON-LUNG study proposes to collect serum, plasma, tissue, and CT images from patients receiving pembrolizumab or pembrolizumab plus carboplatin-based chemotherapy to help identify patients who may benefit from a more aggressive triplet treatment regimen. As part of the study, patient samples undergo a serum-based pretreatment evaluation of the circulating proteome (hereafter referred to as Primary Immune Response or PIR test). This test utilizes mass spectrometry with machine learning and was developed by Biodesix, Inc. to classify patients as responders or non-responders, which could help identify patients who may benefit from a triplet treatment regimen.

This research study is for treatment naïve advanced stage NSCLC patients with PD-L1 expression ≥50% treated with pembrolizumab monotherapy, or pembrolizumab with chemotherapy.

This trial is sponsored by Biodesix, Inc. (Boulder, CO), a company that specializing in liquid biopsy and lung cancer diagnostics. To learn more about Biodesix, visit their website at https://www.biodesix.com.

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Study Purpose
To collect biospecimens and evaluate candidate biomarkers of early progression in NSCLC patients with PD-L1 expression ≥50% treated with pembrolizumab monotherapy, or pembrolizumab with chemotherapy.
What Should You Expect in This Study
The research study has certain requirements that must be met. If you do not meet the requirements, you will not be able to participate in this research study.

The process begins when you speak with a member of the study team to learn about the study activities. After you speak with the study team, you will be provided with an Informed Consent Form to review. The Informed Consent Form explains this research study in detail.

If you are eligible for the study, you will work with the study team to complete the following tasks:
Your treating study physician will be asked to provide a blood sample approximately three (3) times over the course of three (3) years. If you leave the study earlier than 3 years, you may experience fewer blood draws.

The blood will be sent to a company named, Biodesix, to study the changes in circulating proteins that may predict response to checkpoint immunotherapy.

You will not be told the results of research testing performed on your blood specimen.

Follow Up for 3 Years – We would like to track your medical condition for up to three (3) years. We would like to do this by contacting you every 3 months to see how you are doing or by reviewing your medical records. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research study.
How To Participate
Individuals being treated at a participating institution may join the study. For a list of participating centers, visit clinicaltrials.gov (here is the hyperlink to the BEACON-LUNG study https://clinicaltrials.gov/ct2/show/NCT04676386)

  1. The first step is to complete the Contact Form. A member of our study team will contact you to discuss your interest in the study.
  2. The study team will review the study requirements and, if you meet the pre-screening requirements, you will be provided access to a participating institution.
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