BEACON-LUNG: 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

Sponsor

Addario Lung Cancer Medical Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04676386

Collaborator

Biodesix, Inc. (Industry)

390

Enrollment

Locations

36.9

Anticipated Duration (Months)

195

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

PD1/PD-L1

Standard of Care: PD1/PD-L1 monotherapy

Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.

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.

Outcome Measures

Primary Outcome Measures

Biomarker PIR evaluation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Addario Lung Cancer Medical Institute (ALCMI)	San Carlos	California	United States	94070
2	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Addario Lung Cancer Medical Institute
Biodesix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Addario Lung Cancer Medical Institute

ClinicalTrials.gov Identifier:

NCT04676386

Other Study ID Numbers:

ALCMI-014

First Posted:

Dec 21, 2020

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 11, 2022