[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"the-pre-cachexia-or-cachexia-patients-who-have-not-received-systemic-treatment-and-are-not-eligible-for-curative-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:the-pre-cachexia-or-cachexia-patients-who-have-not-received-systemic-treatment-and-are-not-eligible-for-curative-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100589960","phase-3-nano-crystalline-megestrol-acetate-combined-with-standard-treatment-versus-standard-treatment-for-first-line-extensive-stage-small-cell-lung-cancer-in-the-cachexia-phase-100589960",false,"NCT06961201","Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase","A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer (ES-SCLC) in the Cachexia Phase","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Life expectancy of ≥6 months.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Study Group (VALG) staging system).\n* Participants must not have previously received systemic chemotherapy for ES-SCLC. For participants who have previously received adjuvant\u002Fneoadjuvant chemotherapy for non-metastatic disease with curative intent or concurrent\u002Fsequential chemoradiotherapy for locally advanced disease, they are eligible for this study if disease progression occurs \\>6 months after the completion of the last treatment.\n* Participants who have previously received PD-1\u002FL1 inhibitors in the neoadjuvant setting are allowed to participate in this study after investigator assessment and agreement. Participants who have previously received PD-1\u002FL1 inhibitors in the adjuvant setting or as consolidation therapy after curative chemoradiotherapy are not eligible for this study.\n* At least one measurable tumor lesion according to RECIST v1.1.\n* Meet the criteria for pre-cachexia or cachexia diagnosis (based on the Fearon diagnostic criteria).\n\nExclusion Criteria:\n\n* Presence of conditions that may affect gastrointestinal absorption, such as dysphagia, malabsorption, history of gastrectomy, or uncontrollable vomiting; ongoing enteral feeding or parenteral nutrition; or anorexia due to neurological causes, psychiatric conditions, or pain that makes eating difficult.\n* Currently taking or planning to take other medications that increase appetite or weight, such as corticosteroids (excluding short-term use of dexamethasone during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n* Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes mellitus.\n* Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional trial or the follow-up period of an interventional study.\n* Presence of unresolved toxicities from prior anti-tumor treatments. Unresolved is defined as not having returned to Grade 0 or 1 according to NCI CTCAE Version 5.0 (except for alopecia) or not having returned to the levels specified in the enrollment\u002Fexclusion criteria.","ALL","18 Years","85 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.",[27,28],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy","NOT_YET_RECRUITING","2025-04-29",{"date":32,"type":33},"2025-05-07","ACTUAL",{"date":35,"type":21},"2025-05-01",{"date":37,"type":21},"2027-06-30",{"name":39,"class":40},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY"]