[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604521":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":20,"armGroups":21,"interventions":16,"overallOfficials":28,"centralContacts":36,"locations":41,"responsibleParty":71,"collaborators":74,"id":79,"slug":16,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":16,"enrollmentInfo":87,"targetDuration":16,"studyType":90,"phases":16,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":106,"whyStopped":16,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"General technical success rate for multiplex immunofluorescence staining per biopsy","defined as a staining, which is:\n\n1. considered evaluable by a trained pathologist according to the HE-, and multiplex-stained overview\n2. PanCK positive\n3. for which negative control and positive control stained in the same run are negative and positive, respectively.\n\nEstimated at 60 %.","From enrollment until completion of all planned biopsy time points (baseline, 6 weeks after start of immunochemotherapy, and at each progression or therapy line change), up to approximately 24 months.",{"measure":14,"description":15,"timeFrame":12},"General success rate for the 3'RNA-Sequencing Approach per biopsy","defined as\n\n1. successful 3'RNA-isolation and -sequencing,\n2. keratin 18 (KRT18) expression is clearly detected above background, e.g. above a 5 Counts per million (CPM) cutoff and\n3. is considered evaluable by trained molecular biologist according to the sequencing results.\n\nFor 3'RNA-Seq, gene-specific expression distributions will be used to calibrate CPM, ranks, or similar metric cutoffs to define positivity\u002Fnegativity.\n\nEstimated at 60 %.",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":18,"timePerspective":19,"maskingInfo":16},"COHORT","PROSPECTIVE","Participants will be adult patients (≥18 years) with histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) who are initiating or receiving standard-of-care immunochemotherapy. Eligible participants must be able to provide tumor biopsy material at predefined time points (baseline, 6 weeks after treatment start, and\u002For at progression or therapy line change). Both male and female patients will be included.",[22,25],{"label":23,"type":16,"description":24,"interventionNames":16},"Kohort A","Patients with advanced non-small cell lung cancer (NSCLC) who undergo tumor biopsy at initial diagnosis and a second biopsy approximately 6 weeks after starting standard-of-care immunochemotherapy. Biospecimens will be analyzed using multiplex immunofluorescence and 3'-RNA sequencing to study immune and tumor-associated biomarkers.",{"label":26,"type":16,"description":27,"interventionNames":16},"Kohort B","Patients with advanced NSCLC who undergo tumor biopsy at the time of disease progression or therapy line change while receiving standard-of-care immunochemotherapy. Biospecimens will be analyzed using multiplex immunofluorescence and 3'-RNA sequencing to study immune and tumor-associated biomarkers.",[29,33],{"name":30,"affiliation":31,"role":32},"Martin Wermke, Prof. Dr.","Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Jürgen Wolf, Prof. Dr.","Klinik I für Innere Medizin, CIO, Universitätsklinikum Köln",[37],{"name":30,"role":38,"phone":39,"phoneExt":16,"email":40},"CONTACT","+49 351 458 16226","impalux-studie@ukdd.de",[42,59],{"facility":43,"status":16,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln","Cologne","North Rhine-Westphalia","50937","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],6.95,50.93333,{"lat":53,"lon":52},[56],{"name":34,"role":38,"phone":57,"phoneExt":16,"email":58},"+49221 478 89050","lungenkrebs@uk-koeln.de",{"facility":60,"status":16,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Universitätsklinikum Carl Gustav Carus","Dresden","Saxony","01307",{"type":50,"coordinates":65},[66,67],13.73832,51.05089,{"lat":67,"lon":66},[70],{"name":30,"role":38,"phone":39,"phoneExt":16,"email":40},{"type":32,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Dr. med. Martin Wermke","Prof. Dr. med.",[75,77],{"name":76,"class":6},"Deutsche Krebshilfe e.V., Bonn (Germany)",{"name":78,"class":6},"Universitätsklinikum Köln","100604521",false,"NCT07150598","Immune-Marker Platform for Patients With Advanced Lung Cancer","IMPALUX","Inclusion Criteria:\n\nFor all:\n\n* Written informed consent of the patient\n* Consent of participation in the national Network for Genomic Medicine in Lung Cancer (nNGM)\n* Advanced lung cancer with non-curative treatment option (NSCLC)\n* No targetable driver mutation detected, defined as no targetable drive mutation in ALK, EGFR, BRAF, HER2, MET, NTRK, RET, ROS1\n* PD-L1 expression on tumor cells (TPS \\\u003C 50%)\n\nCohort A:\n\n* Previously untreated NSCLC without curative treatment options\n* Sufficient pre-treatment tumor material available for the planned analyses or consenting and able to undergo additional pretreatment biopsy\n* Scheduled to undergo immune(chemo)therapy\n* Willing and able to undergo re-biopsy 6 weeks after start of immune(chemo)therapy\n\nCohort B:\n\n* Any line of progression after firstline immune(chemo)therapy\n* Sufficient tumor material obtained after progression on most recent line of treatment available or willing and able to undergo re-biopsy prior to next line treatment\n\nExclusion Criteria:\n\n* Any condition representing an unjustified risk for obtaining an additional biopsy sample (if needed) in the view of the investigator\n* Incapability of understanding the purpose and possible consequences of the trial\n* Substance abuse, medical, psychological or social conditions that may interfere with the subject's cooperation with the requirements of the trial or evaluation of the study results","ALL","18 Years",{"count":88,"type":89},500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to better understand how the immune system and certain tumor markers are linked to treatment response in patients with advanced non-small cell lung cancer (NSCLC) who receive immunochemotherapy.\n\nThe investigators aim to answer the following questions:\n\n* Can the investigators successfully analyze immune markers and gene activity from small tumor samples (biopsies)?\n* Are these markers connected to how well patients respond to immunochemotherapy and how their disease progresses?\n\nWhat will participants do?\n\n* Provide tumor tissue samples (biopsies) at key points: before treatment, about 6 weeks after starting immunochemotherapy, and if the cancer grows or treatment changes.\n* Allow their tumor samples to be analyzed in the lab using advanced techniques to measure immune and genetic markers.\n* Share clinical information (such as treatment response and disease progression) so investigators can study how it relates to these markers.\n\nThis study does not test a new drug or treatment.",[93,94,95],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC Stage IIIB~IV","NSCLC Non-small Cell Lung Cancer",[97,98,99,100,101,102,103,104,105],"Non-Small Cell Lung Cancer","NSCLC","Immunochemotherapy","Multiplex Immunofluorescence","3'-RNA Sequencing","Prospective Observational Study","Tumor Microenvironment","Therapy Response","Precision Oncology","NOT_YET_RECRUITING","2025-09-01",{"date":109,"type":110},"2025-09-08","ACTUAL",{"date":107,"type":89},{"date":113,"type":89},"2027-06-01",{"name":5,"class":6},2]