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Evaluating Modifiable Biomarkers for the Prediction of Immunotherapy Response and Toxicity

NCT04954885 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2025-01-27

No results posted yet for this 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.

Conditions

  • Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo stool sample

OTHER

Physical Performance Testing

Undergo short physical performance battery

OTHER

Physical Performance Testing

Perform 6-minute walk test

OTHER

Questionnaire Administration

Complete questionnaires

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Daniel Spakowicz, PhD, MS · Ohio State University Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-10-12
Completion
2022-10-12

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 NCT04954885 on ClinicalTrials.gov