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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

NCT04676386 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2024-02-02

No results posted yet for this 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.

Conditions

  • NSCLC Stage IV
  • NSCLC, Stage IIIC

Interventions

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.

Sponsors & Collaborators

  • Biodesix, Inc.

    collaborator INDUSTRY

  • Addario Lung Cancer Medical Institute

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676386 on ClinicalTrials.gov