[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603026":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":22,"responsibleParty":38,"collaborators":40,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"NSCLC patients who started neoadjuvant chemo-immontherapy followed by cancellation of surgery",null,"Stage II-III NSCLC patients who started neoadjuvant chemo-immontherapy between January 1st 2022 to September 30th 2024 followed by cancellation of surgery",[13],{"name":14,"affiliation":15,"role":16},"Jair Bar, MD-PhD","Jusidman Cancer Center, Sheba Medical Center","PRINCIPAL_INVESTIGATOR",[18],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","972-3530-7096","Jair.Bar@sheba.health.gov.il",[23],{"facility":15,"status":24,"city":25,"state":10,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Ramat Gan","5262000","Israel","IL",{"type":30,"coordinates":31},"Point",[32,33],34.81065,32.08227,{"lat":33,"lon":32},[36],{"name":14,"role":19,"phone":37,"phoneExt":10,"email":21},"972-3530-7097",{"type":39,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[41,44,46,48,50,52,54,56,58,60],{"name":42,"class":43},"Rambam Health Care Campus","OTHER",{"name":45,"class":43},"Soroka University Medical Center",{"name":47,"class":43},"Gustave Roussy, Cancer Campus, Grand Paris",{"name":49,"class":43},"Hadassah Medical Organization",{"name":51,"class":43},"Rabin Medical Center",{"name":53,"class":43},"University Hospital, Geneva",{"name":55,"class":6},"Tel-Aviv Sourasky Medical Center",{"name":57,"class":43},"MedStar Georgetown University Hospital",{"name":59,"class":43},"Mayo Clinic",{"name":61,"class":43},"UOMi Cancer Center","100603026","real-world-stage-ii-iii-nsclc-patients-receiving-neoadjuvant-chemo-immunotherapy-and-no-surgical-resection-100603026",false,"NCT07131163","Real World Stage II-III NSCLC Patients Receiving Neoadjuvant Chemo-immunotherapy and no Surgical Resection","Neoadjuvant Chemo-immunotherapy Not Resected","NoSurgery","Inclusion Criteria:\n\n1. Stage II-III NSCLC patient, based on clinical staging.\n2. Treated by a chemo-immunotherapy regimen defined as neoadjuvant treatment, for at least one cycle of treatment.\n3. No surgery was performed for at least six months from initiation of the neoadjuvant treatment.\n4. availability of data about reasons for surgery cancellation and clinical follow up.\n5. patient's consent for data collection (or waiver of the need for consent by the local ethics committee)\n6. At least 6 month of follow up after intiation of neoadjuvant treatment.","ALL","18 Years",{"count":73,"type":74},60,"ESTIMATED","OBSERVATIONAL","Neoadjuvant chemo-immunotherapy, with or without adjuvant immunotherapy, is currently the standard of care for resectable stage II-III NSCLC. One of the major drawbacks of neoadjuvant treatment is the risk of surgery cancellation. In most of the studies including a neoadjuvant component of treatment, about 20% of recruited patients do not undergo surgery. The reasons for surgery cancellation are recorded as a mixture of adverse events, disease progression, patient's decision and physician's decision. There is lack of data about the precise reasons for cancellation of the surgery. For patients starting neoadjuvant chemo-immunotherapy followed be cancellation of surgery, there is lack of data about the need to add additional treatments and about outcome of these treatments. Depending on the reason for surgery cancellation, these patients might undergo salvage radiotherapy (or chemo-radiotherapy), switch to systemic treatment as for metastatic disease or to palliative care.\n\nGoal of the study: to collect real-world data about NSCLC patients that started neoadjuvant chemo-immunotherapy and did not get to surgery.\n\nStudy conduct Participating centers will secure approvals for retrospective collection of clinical data. Relevant patients will be identified from the working database of each center, data will be collected locally, deidentified and collected centrally at the Sheba MC.\n\nData collected will include: demographics (age, sex); patients' characteristics (smoking status, co-morbidities, ECOG-PS, weight loss); tumor characteristics (histology, molecular tests, specific test results, clinical stage); staging procedures done (CT, PET-CT, brain MRI, EBUS, mediastinoscopy); neoadjuvant treatment (regimen, number of cycles, dose reductions, delays); reason for surgery cancellation; to be categorized according to the following options: iRAE\u002F non-immune-related AEs\u002F molecular test results\u002F re-staging result showing lack of mediastinal clearing\u002F distant disease progression\u002F local progression leading to patient becoming not-resectable\u002F re-assessment of patient as not-resectable (without a significant change in the tumor)\u002F change in the patient condition making the patient not-operable.\n\nMajor Inclusion criteria:\n\n1. Stage II-III NSCLC patient, based on clinical staging.\n2. Treated by a chemo-immunotherapy regimen defined as neoadjuvant treatment, for at least one cycle of treatment.\n3. No surgery was performed for at least six months from initiation of the neoadjuvant treatment.",[78],"Stage II-III Non-small Cell Lung Cancer",[80,81,82,83,84],"neoadjuvant","NSCLC","Non-small-cell lung cancer","immunotherapy","chemotherapy","2025-08-12",{"date":87,"type":88},"2025-08-20","ACTUAL",{"date":90,"type":88},"2024-07-16",{"date":92,"type":74},"2025-12-30",{"name":5,"class":6},1]