RecruitingNCT04913311

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy

Sponsor

M.D. Anderson Cancer Center

Enrollment

150 participants

Start Date

Jan 21, 2021

Study Type

OBSERVATIONAL

Conditions

Lung Non-Small Cell Carcinoma

Summary

This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tracks lung function and biological markers in people with non-small cell lung cancer (NSCLC) who receive standard chemoradiation followed by immunotherapy (durvalumab) to identify early warning signs of pneumonitis — a potentially serious lung inflammation caused by these treatments. **You may be eligible if...** - You are newly diagnosed with NSCLC and are starting the standard treatment of concurrent chemotherapy plus radiation followed by durvalumab (the PACIFIC regimen) - You plan to receive all treatment and follow-up at MD Anderson Cancer Center - You have a smartphone capable of connecting to the internet - You are able and willing to perform home breathing tests (spirometry) weekly **You may NOT be eligible if...** - You are not receiving the PACIFIC regimen - You do not have access to a smartphone with data or wireless capability - You are unwilling or unable to perform home spirometry - You have an absolute contraindication to performing spirometry Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples

PROCEDUREBronchoscopy with Bronchoalveolar Lavage

Undergo bronchoscopy with BAL

OTHERChemoradiotherapy

Undergo concurrent chemoradiation per standard of care

PROCEDUREComputed Tomography

Undergo computed tomography scan

OTHERDiagnostic Laboratory Biomarker Analysis

Correlative studies

DRUGImmune Checkpoint Inhibitor

Receive CPI per standard of care

PROCEDURENasal Wash and Collection

Undergo nasal wash

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESpirometry

Under lung spirometry tests

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04913311

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