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NCT04676386 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Addario Lung Cancer Medical Institute.

Terminated
Registry status
29
Enrollment target

NCT04676386: Clinical Trial study, sponsored by Addario Lung Cancer Medical Institute.

NCT04676386 is a clinical trial that was terminated before completion, run by Addario Lung Cancer Medical Institute. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04676386 was terminated before completion, sponsored by Addario Lung Cancer Medical Institute.

TERMINATED
Registry status
29 participants
Enrollment target

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.

Primary Outcome

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

Interventions

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

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-02-01
Est. Completion 2023-12-30

Why NCT04676386 stopped before completion

NCT04676386 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Primary Immune Response (PIR) test by Biodesix, Inc. is the first listed.

NCT04676386 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04676386 about?

NCT04676386 is a clinical study titled "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". 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 ...

What is the current status of trial NCT04676386?

This trial is currently terminated. The enrollment target is 29 participants. The study started on 2021-02-01. Estimated completion is 2023-12-30.

What interventions are being tested in trial NCT04676386?

The interventions under investigation include: Primary Immune Response (PIR) test by Biodesix, Inc. (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04676386?

This trial is sponsored by Addario Lung Cancer Medical Institute, which has 8 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04676386, the US trial registry maintained by the National Library of Medicine. NCT04676386 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.