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

NCT04913311 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Lung Non-Small Cell Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

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

PROCEDURE

Bronchoscopy with Bronchoalveolar Lavage

Undergo bronchoscopy with BAL

OTHER

Chemoradiotherapy

Undergo concurrent chemoradiation per standard of care

PROCEDURE

Computed Tomography

Undergo computed tomography scan

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

DRUG

Immune Checkpoint Inhibitor

Receive CPI per standard of care

PROCEDURE

Nasal Wash and Collection

Undergo nasal wash

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Spirometry

Under lung spirometry tests

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ajay Sheshadri · M.D. Anderson Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2027-02-02
Completion
2027-02-02

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 NCT04913311 on ClinicalTrials.gov