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.
Newly-diagnosed NSCLC patients who will be undergoing concurrent chemotherapy and radiotherapy (XRT) followed by immune checkpoint inhibitors (CPI) therapy with durvalumab, as per the PACIFIC trial
Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC)
Has access to a smartphone with the ability to transmit data via wireless connection or through their personal cellular plan
Able and willing to perform home spirometry (HS) weekly without absolute contraindications to performing spirometry
None
Patients with newly-diagnosed NSCLC (with a particular focus on lung inflammation) scheduled to undergo chemoradiation followed by immunotherapy.
Cohort
Prospective
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
Bronchoscopy with Bronchoalveolar Lavage
Procedure/SurgeryUndergo bronchoscopy with BAL
Chemoradiotherapy
Other interventionUndergo concurrent chemoradiation per standard of care
Computed Tomography
Procedure/SurgeryUndergo computed tomography scan
Diagnostic Laboratory Biomarker Analysis
Other interventionCorrelative studies
Immune Checkpoint Inhibitor
DrugReceive CPI per standard of care
Nasal Wash and Collection
Procedure/SurgeryUndergo nasal wash
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Spirometry
Procedure/SurgeryUnder lung spirometry tests
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.
The M.D. Anderson Symptom Index (MDASI)
Monitor home spirometry and symptoms to identify early pneumonitis. The MDASI is a brief (less than 5 minutes), psychometrically validated, multi-symptom assessment tool developed for use with cancer patients who are either undergoing or have completed cancer therapies. MDASI-immunotherapy will be administered weekly for the first 9 weeks of study, every two weeks from week 10 to week 54, and monthly until the end of study (week 62). If MDASI increases by 1, patients will be contacted to be evaluated for the possible development of pneumonitis, infection, or disease progression.
Use of home spirometry
Home spirometry will measured forced lung function values such as vital capacity which will be monitored over time in study participants.
Development of treatment-emergent immune related adverse events (irAE)
The development of treatment-emergent irAE overall and separately by type of AE will be summarized by the method of Kaplan and Meier. For AEs with enough events, may use Cox regression models to model the association with covariates of interest, including blood biomarkers.
Sleep quality
Will assess the association between chemotherapy followed by immunotherapy and sleep quality by using the Pittsburgh Quality Sleep Index (PQSI).
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