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

Conditions

• Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
• Bronchoscopy with Bronchoalveolar Lavage — PROCEDURE
  Undergo bronchoscopy with BAL
• Chemoradiotherapy — OTHER
  Undergo concurrent chemoradiation per standard of care
• Computed Tomography — PROCEDURE
  Undergo computed tomography scan
• Diagnostic Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Immune Checkpoint Inhibitor — DRUG
  Receive CPI per standard of care
• Nasal Wash and Collection — PROCEDURE
  Undergo nasal wash
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Spirometry — PROCEDURE
  Under lung spirometry tests

Study Details

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.

Key Dates

Start date

Jan 21, 2021

Status verified

Feb 2026

Primary completion

Feb 2, 2027

Completion

Feb 2, 2027

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC) [ Time Frame: Up to 12 months ]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
  PHASE3 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska
• Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
  Recruiting · Roswell Park Cancer Institute · Buffalo, New York