NCT04954885

Evaluating Modifiable Biomarkers for the Prediction of Immunotherapy Response and Toxicity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To quantify the performance of two modifiable biomarkers -- the microbiome and functional status - to use as predictive and/or prognostic indicators of clinical benefit (overall survival, progression-free survival) in lung cancer patients who receive randomized treatment combinations prescribed by the INSIGNA protocol. SECONDARY OBJECTIVE: I. To quantify the predictive power of two modifiable biomarkers - the microbiome and functional status -- for the development of immune-related adverse events (irAEs). OUTLINE: Patients receive treatment by their treating physician as described in the INSIGNA protocol based on their designated treatment arm. Patients then undergo stool sample collection, complete questionnaires and functional status assessments, such as short physical performance battery over 10 minutes and 6 minute walk test, at baseline, days 40 (cycle 3), day 80 (cycle 5), day 180 (cycle 10) and end of treatment (up to 2 years).

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

Type	Name	Description
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

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2021-07-08
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States