Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

9mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 years study duration

Study Progress88%

Jan 2021Feb 2027

Study Start

First participant enrolled

January 21, 2021

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed

2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

April 20, 2021

Last Update Submit

February 17, 2026

Conditions

Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
All possible pneumonitis events will be adjudicated by an expert committee including Dr. Altan, Dr. Sheshadri, an expert infectious disease doctor, and an expert thoracic radiologist. Logistic regression will be used to assess the association between the development of pneumonitis and covariates of interest. Will also use logistic regression to model the association between the development of immune checkpoint inhibitor (CPI)-related pneumonitis and separately the development of radiation related pneumonitis. Secondary analyses of the primary endpoint will include assessing the time to the development of pneumonitis. Cox regression models will be fit in a similar manner to assess the association with the same covariates.
Up to 12 months

Secondary Outcomes (6)

The M.D. Anderson Symptom Index (MDASI)
Up to 12 months
Use of home spirometry
Up to 12 months
Development of treatment-emergent immune related adverse events (irAE)
Up to 12 months
Sleep quality
Up to 12 months
Financial hardship
Up to 12 months
+1 more secondary outcomes

Study Arms (1)

Observational (biospecimen collection, standard treatment)

Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.

Procedure: Biospecimen CollectionProcedure: Bronchoscopy with Bronchoalveolar LavageOther: ChemoradiotherapyProcedure: Computed TomographyOther: Diagnostic Laboratory Biomarker AnalysisDrug: Immune Checkpoint InhibitorProcedure: Nasal Wash and CollectionOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Spirometry