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)

• ClinicalTrials.gov Identifier: NCT04676386
• Recruitment Status: Recruiting
• First Posted: December 21, 2020
• Last Update Posted: January 11, 2022
• Sponsor: Addario Lung Cancer Medical Institute
• Collaborator: Biodesix, Inc.
• Information provided by (Responsible Party): Addario Lung Cancer Medical Institute

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
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
• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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.

More Information

• Responsible Party: Addario Lung Cancer Medical Institute
• ClinicalTrials.gov Identifier: NCT04676386
• Other Study ID Numbers: ALCMI-014
• First Posted: December 21, 2020
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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