[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432607":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":90,"centralContacts":10,"locations":94,"responsibleParty":116,"collaborators":10,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":10,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":10,"maxAge":10,"enrollmentInfo":126,"targetDuration":10,"studyType":129,"phases":10,"briefSummary":130,"conditions":131,"keywords":10,"overallStatus":97,"whyStopped":10,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational (biospecimen collection, standard treatment)",null,"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\u002For 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.",[13,14,15,16,17,18,19,20,21,22],"Procedure: Biospecimen Collection","Procedure: Bronchoscopy with Bronchoalveolar Lavage","Other: Chemoradiotherapy","Procedure: Computed Tomography","Other: Diagnostic Laboratory Biomarker Analysis","Drug: Immune Checkpoint Inhibitor","Procedure: Nasal Wash and Collection","Other: Quality-of-Life Assessment","Other: Questionnaire Administration","Procedure: Spirometry",[24,29,36,47,59,63,68,77,83,86],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"PROCEDURE","Biospecimen Collection","Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Bronchoscopy with Bronchoalveolar Lavage","Undergo bronchoscopy with BAL",[9],[34,35],"bronchial washing","Bronchoscopy\u002FLavage",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Chemoradiotherapy","Undergo concurrent chemoradiation per standard of care",[9],[41,42,43,44,45,46],"Chemoradiation","CRT","CRTx","Radiochemotherapy","RCTx","RT-CT",{"type":25,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Computed Tomography","Undergo computed tomography scan",[9],[52,53,54,55,56,57,58],"CAT","CAT Scan","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan","tomography",{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":10},"Diagnostic Laboratory Biomarker Analysis","Correlative studies",[9],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":10},"DRUG","Immune Checkpoint Inhibitor","Receive CPI per standard of care",[9],{"type":25,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Nasal Wash and Collection","Undergo nasal wash",[9],[73,74,75,76],"Nasal Lavage","Nasal Wash","Nasopharyngeal Lavage","Nasopharyngeal Wash",{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Quality-of-Life Assessment","Ancillary studies",[9],[82],"Quality of Life Assessment",{"type":6,"name":84,"description":79,"armGroupLabels":85,"otherNames":10},"Questionnaire Administration",[9],{"type":25,"name":87,"description":88,"armGroupLabels":89,"otherNames":10},"Spirometry","Under lung spirometry tests",[9],[91],{"name":92,"affiliation":5,"role":93},"Ajay Sheshadri","PRINCIPAL_INVESTIGATOR",[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-95.36327,29.76328,{"lat":107,"lon":106},[110,115],{"name":111,"role":112,"phone":113,"phoneExt":10,"email":114},"Ajay Sheshadri, MD","CONTACT","713-792-6238","asheshadri@mdanderson.org",{"name":92,"role":93,"phone":10,"phoneExt":10,"email":10},{"type":117,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100432607","predictive-biomarkers-for-pneumonitis-after-chemoradiotherapy-and-immunotherapy-in-patients-with-non-small-cell-lung-cancer-100432607",false,"NCT04913311","Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer","Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy","Inclusion Criteria:\n\n* 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\n* Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC)\n* Has access to a smartphone with the ability to transmit data via wireless connection or through their personal cellular plan\n* Able and willing to perform home spirometry (HS) weekly without absolute contraindications to performing spirometry","ALL",{"count":127,"type":128},150,"ESTIMATED","OBSERVATIONAL","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.",[132],"Lung Non-Small Cell Carcinoma","2026-08-07",{"date":135,"type":136},"2026-08-11","ACTUAL",{"date":138,"type":136},"2021-01-21",{"date":140,"type":128},"2027-02-02",{"name":5,"class":6},1]