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Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy (BEACON-LUNG)

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ClinicalTrials.gov Identifier: NCT04676386
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Biodesix, Inc.
Information provided by (Responsible Party):
Addario Lung Cancer Medical Institute

Brief Summary:
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) > 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.

Condition or disease Intervention/treatment
NSCLC Stage IV NSCLC, Stage IIIC Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.

Detailed Description:

This is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung cancer (NSCLC) and PD-L1 TPS ≥50% treated with two standard of care (SOC) regimens, platinum based PD-1/PD-L1 regimen with monotherapy (single agent PD-1/PD-L1 therapy).

Prior to enrollment, tumor specimens will be tested for PD-L1 expression according to participating centers' standard operating procedures. Patients will be treated, according to physician choice, with platinum-based PD-1/PD-L1 regimen versus single agent PD-1/PD-L1 regimen. For each treatment cohort of 195 patients, enrollment will proceed in sub-cohorts to ensure a population with 20% ECOG PS2 patients and a total of 40 squamous cell carcinoma patients per treatment arm.

Patients will receive one of the following standard-of-care (SOC) treatment regimens at the discretion of the treating investigator:

  • PD-1/PD-L1 therapy
  • Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination

Tumor assessment will follow RECIST v1.1.

Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.

Remaining serum and plasma will be stored for subsequent exploratory studies and will be available to the investigators in the ALCMI network per ALCMI standard operating procedures.

Additionally, pathology reports including PD-L1 results and Next Generation Sequencing results, from any CLIA laboratory, will be collected.

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Study Type : Observational
Estimated Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Group/Cohort Intervention/treatment
PD1/PD-L1
Standard of Care: PD1/PD-L1 monotherapy
Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.
Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.

PD1/PD-L1 + chemo
Standard of Care: Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination
Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.
Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.




Primary Outcome Measures :
  1. Biomarker PIR evaluation [ Time Frame: 3 years ]
    To collect biospecimens and evaluate candidate biomarkers of early progression on patients with >50% PD-L1 positive tumors treated with PD-1/PD-L1 monotherapy or PD-1/PD-L1/chemotherapy combination


Biospecimen Retention:   Samples With DNA

A maximum of three blood draws will be performed over three years.

Approximately 25 mLs venous blood will be collected into blood collection tubes provided in the study kit. Blood should be drawn at the time of other clinical laboratories whenever possible to prevent additional venipuncture or port access, otherwise, a study-specific blood draw may occur at the time of the standard of care office visit.

Peripheral blood draws may occur on-site or via a remote phlebotomist dispatched by the enrolling institution. Sites may mail the blood draw kit to the subject prior to arrival of the remote phlebotomist.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients will be treatment-naïve advanced NSCLC patients with PD-L1 TPS ≥50% who will receive PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin and are managed per treating physician's standard of care.
Criteria

Inclusion Criteria:

  • Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS > 50%
  • Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin
  • ECOG PS 0-2
  • Ability to consent to participate in the study

Exclusion Criteria:

  • Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676386


Locations
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United States, California
Addario Lung Cancer Medical Institute (ALCMI) Enrolling by invitation
San Carlos, California, United States, 94070
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: MaryJo Fidler, MD    312-942-5498    rush_research_portal@rush.edu   
Sponsors and Collaborators
Addario Lung Cancer Medical Institute
Biodesix, Inc.
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Responsible Party: Addario Lung Cancer Medical Institute
ClinicalTrials.gov Identifier: NCT04676386    
Other Study ID Numbers: ALCMI-014
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases