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NCT04954885 · ClinicalTrials.gov registry record

Evaluating Modifiable Biomarkers for the Prediction of Immunotherapy Response and Toxicity

A clinical trial of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
2
Enrollment target
1
Study location

NCT04954885: Completed study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.

NCT04954885 is a study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8 that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 2 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04954885, a study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
2 participants
Enrollment target
1
Study location

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.

Primary Outcome

Count tables derived from the Kraken/Bracken pipeline output will be used to calculate the diversity metric Simpson's Index to quantify the number of species and evenness of the stool microbiome samples. Diversity will be binarized into high versus (vs) low at the median value, and then this variable used to stratify a Kaplan-Meier survival curve (predictive indicator). This will be further stratified by first-line treatment type (Arms A\&B vs Arm C) to evaluate microbe diversity predicts respon

Conditions Studied

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

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
Ohio State University Comprehensive Cancer Center

341 total trials

What the finished NCT04954885 record still lists

NCT04954885 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (98% lower).

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.

NCT04954885 reports a single indexed study location in Ohio.

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.

What interventions are being tested in trial NCT04954885?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Physical Performance Testing (OTHER).

Who is sponsoring clinical trial NCT04954885?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04954885's enrollment target sits among peer trials

2 82nd of 81 the lowest of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04954885, the US trial registry maintained by the National Library of Medicine. NCT04954885 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.