[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556979":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":10,"centralContacts":103,"locations":112,"responsibleParty":131,"collaborators":10,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":10,"studyType":149,"phases":10,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":115,"whyStopped":10,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,16,25,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A",null,"Male patients diagnosed with advanced\u002Fmetastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment",[13,14,15],"Drug: Alectinib","Drug: Brigatinib","Drug: Lorlatinib 100 mg",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort B","Male patients diagnosed with advanced\u002Fmetastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment",[20,21,22,23,24],"Drug: Osimertinib","Drug: Sotorasib","Drug: Dabrafenib","Drug: Trametinib","Drug: Selpercatinib",{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort C","Male patients diagnosed with advanced\u002Fmetastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)",[29,30,31],"Drug: Pembrolizumab","Drug: Cemiplimab","Drug: Nivolumab",{"label":33,"type":10,"description":34,"interventionNames":35},"Cohort D","Male patients diagnosed with advanced\u002Fmetastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy",[29,30,31,36,37,38],"Drug: Carboplatin","Drug: Pemetrexed","Drug: Paclitaxel",[40,47,53,59,63,67,71,75,79,83,87,91,95,99],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Alectinib","Alectinib 600 mg\u002FBID",[9],[46],"Alecensa",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Brigatinib","180 mg\u002Fdaily",[9],[52],"ALUNBRIG",{"type":41,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Lorlatinib 100 mg","100 mg\u002Fdaily",[9],[58],"LORVIQUA",{"type":41,"name":60,"description":61,"armGroupLabels":62,"otherNames":10},"Osimertinib","80 mg\u002Fdaily",[17],{"type":41,"name":64,"description":65,"armGroupLabels":66,"otherNames":10},"Sotorasib","960 mg\u002Fdaily",[17],{"type":41,"name":68,"description":69,"armGroupLabels":70,"otherNames":10},"Dabrafenib","150 mg\u002FBID",[17],{"type":41,"name":72,"description":73,"armGroupLabels":74,"otherNames":10},"Trametinib","2 mg\u002Fdaily",[17],{"type":41,"name":76,"description":77,"armGroupLabels":78,"otherNames":10},"Selpercatinib","160 mg\u002FBID",[17],{"type":41,"name":80,"description":81,"armGroupLabels":82,"otherNames":10},"Pembrolizumab","200 mg intravenous every 21 days",[26,33],{"type":41,"name":84,"description":85,"armGroupLabels":86,"otherNames":10},"Cemiplimab","350 mg intravenous every 21 days",[26,33],{"type":41,"name":88,"description":89,"armGroupLabels":90,"otherNames":10},"Nivolumab","240 mg intravenous every 14 days",[26,33],{"type":41,"name":92,"description":93,"armGroupLabels":94,"otherNames":10},"Carboplatin","AUC4\u002FAU5 intravenous every 21 days",[33],{"type":41,"name":96,"description":97,"armGroupLabels":98,"otherNames":10},"Pemetrexed","500 mg\u002Fmq intravenous every 21 days",[33],{"type":41,"name":100,"description":101,"armGroupLabels":102,"otherNames":10},"Paclitaxel","175 mg\u002Fmq intravenous every 21 days",[33],[104,109],{"name":105,"role":106,"phone":107,"phoneExt":10,"email":108},"Emilio Bria, MD","CONTACT","0630156318","emilio.bria@policlinicogemelli.it",{"name":110,"role":106,"phone":107,"phoneExt":10,"email":111},"Emanuele Vita, MD","dr.emanuele.vita@gmail.com",[113],{"facility":114,"status":115,"city":116,"state":10,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Fondazione Policlinico Gemelli IRCCS","RECRUITING","Rome","00168","Italy","IT",{"type":121,"coordinates":122},"Point",[123,124],12.51133,41.89193,{"lat":124,"lon":123},[127],{"name":128,"role":106,"phone":129,"phoneExt":130,"email":108},"Emilio Bria, Professor","0630155202","+39",{"type":132,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Bria Emilio","Prof.","100556979","erectile-dysfunctions-gonadotoxicity-and-sexual-health-assessment-in-men-with-lung-cancer-100556979",false,"NCT06532149","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)","EROS","Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic NSCLC\n* To be candidate to active treatment\n* Aged ≥ 18 anni (up to 75 years old)\n* To be sexually active in last 30 days before treatment start\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years\n* Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:\n* Cancer-related conditions that may preclude\u002Fundermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):\n\n  * History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)\n  * Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)\n  * Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics\n  * Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n  * Major psychological disorder and\u002For high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study","MALE","18 Years","75 Years",{"count":147,"type":148},80,"ESTIMATED","OBSERVATIONAL","Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.\n\nThe aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC",[152,153,154,155],"NSCLC Stage IV","Sex Disorder","Hypogonadism, Male","Erectile Dysfunction",[157,158,159,155],"NSCLC","Sexual Health","Male hypogonadism","2024-08-08",{"date":162,"type":163},"2024-08-09","ACTUAL",{"date":165,"type":148},"2024-08-05",{"date":167,"type":148},"2026-09-30",{"name":5,"class":6},1]