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Evaluating Modifiable Biomarkers for the Prediction of Immunotherapy Response and Toxicity

NCT04954885 · View on ClinicalTrials.gov ↗

Study Summary

This study evaluates gut microbiome and functional status as modifiable biomarkers in predicting immunotherapy response and toxicity in patients with stage IV non-squamous non-small cell lung cancer receiving pembrolizumab alone or in combination with pemetrexed and carboplatin on the INSIGNIA trial. The goal of this study is to estimate the extent to which future interventions that seek to rationally modify the gut microbiome and/or functional status can improve outcomes.

Interventions

  • PROCEDURE Biospecimen Collection
  • OTHER Questionnaire Administration
  • OTHER Physical Performance Testing

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center — Columbus

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2021-05-18
Est. Completion 2022-10-12

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04954885

The ClinicalTrials.gov registry entry for NCT04954885 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04954885 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04954885 about?

NCT04954885 is a clinical study titled "Evaluating Modifiable Biomarkers for the Prediction of Immunotherapy Response and Toxicity". This study evaluates gut microbiome and functional status as modifiable biomarkers in predicting immunotherapy response and toxicity in patients with stage IV non-squamous non-small cell lung cancer receiving pembrolizumab alone or in combination with pemetrexed and carboplatin on the INSIGNIA trial...

What is the current status of trial NCT04954885?

This trial is currently completed. The enrollment target is 2 participants. The study started on 2021-05-18. Estimated completion is 2022-10-12.

What conditions does trial NCT04954885 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Lung Non-Squamous Non-Small Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04954885?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Physical Performance Testing (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04954885?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04954885 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial