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

Last updated: February 1, 2024
Sponsor: Addario Lung Cancer Medical Institute
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT04676386
ALCMI-014
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Primary Immune Response (PIR) test by Biodesix, Inc.
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

  • Addario Lung Cancer Medical Institute (ALCMI)

    San Carlos, California 94070
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

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