[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616516":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":79,"collaborators":20,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":20,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":20,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":45,"whyStopped":20,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"STCube, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nelmastobart 800mg+Docetaxel 75mg\u002Fm2","EXPERIMENTAL","Nelmastobart 800mg+Docetaxel 75mg\u002Fm2 fixed",[13],"Drug: Nelmastobart and Docetaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nelmastobart and Docetaxel","Nelmastobart 800mg and Docetaxel 75mg\u002Fm2",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Heeyeon Jung","CONTACT","82-2-551-3370","junghy@stcube.com",[28,43,55,63,71],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":20,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"The Catholic University of Korea St. Vincent's Hospital","NOT_YET_RECRUITING","Gyeonggi-do","South Korea",{"type":34,"coordinates":35},"Point",[36,37],126.76917,37.58944,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":20,"phoneExt":20,"email":20},"Byoung-Yong Shim, M.D, Ph.D","PRINCIPAL_INVESTIGATOR",{"facility":44,"status":45,"city":46,"state":20,"zip":20,"country":32,"countryCode":20,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Kangbuk Samsung 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Hospital",{"type":34,"coordinates":74},[49,50],{"lat":50,"lon":49},[77],{"name":78,"role":42,"phone":20,"phoneExt":20,"email":20},"Yu-Jeong Kim, M.D, Ph.D",{"type":80,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100616516","phase-2-nelmastobart-in-combination-with-docetaxel-in-non-small-cell-lung-cancer-100616516",false,"NCT07306624","Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer","A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination With Docetaxel in Patients With Advanced\u002FMetastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and\u002For Immunotherapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIb, IIIc, or IV 4 recurrent non-squamous NSCLC\n* BTN1A1 TPS score ≥50\n* Subjects with positive AGA must have progressed after At least 1 platinum-based chemotherapy and\u002For immunotherapy AND at least 1 locally approved targeted therapy appropriate to the AGA\n* Subjects with negative AGA must have progressed after prior PD1\u002F (PDL therapy and\u002For platinum-based chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 1.\n* Adequate organ function as described in the protocol\n* Adequate cardiac function as described in the protocol\n* For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.\n* Life expectancy of at least 3 months\n* Has agreed to provide archival tissue\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active ingredients or excipients of the study drug.\n* History of using Docetaxel for palliative therapy.\n* Prior treatment with Cytotoxic chemotherapy or oral targeted therapy within 14 days.\n* Investigational drugs within 5 half-lives.\n* Monoclonal antibodies or ADCs within 4 weeks.\n* Use or expected use of strong CYP3A4 inhibitors (e.g., ketoconazole) within 14 days prior to the first dose.\n* Uncontrolled severe infection requiring IV treatment, or suspected infectious complications\u002Ffever.\n* Requirement for continuous high-dose steroids (\\>10 mg\u002Fday prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent\u002Freplacement therapies allowed).\n* Pregnant or breastfeeding women.\n* History of autoimmune disease requiring systemic treatment within the last 2 years\n* Known active symptomatic or radiologically unstable CNS lesions\n* History of stroke, unstable angina, MI, or NYHA Class III-IV symptoms within 6 months, or current Class II.\n* Systolic BP 160 mmHg or Diastolic BP 100 mmHg, or hypertensive encephalopathy.\n* History of ILD, organizing\u002Fdrug-induced pneumonia, or active pneumonia on screening (mild asymptomatic fibrosis requires consultation).\n* Recipients of allogeneic stem cell or solid organ transplants.\n* Vaccination with live or attenuated live vaccines within 30 days.\n* Maligancies other than NSCLC\n* Failure to recover from prior anti-cancer therapy side effects to CTCAE Grade 1\n* Wide-field bone marrow radiation (\\>30%) within 4 weeks, or limited palliative radiation within 2 weeks.\n* Major surgery within 4 weeks or incomplete recovery from surgical side effects.\n* Evidence of active HBV, HCV, or HIV infection (carriers with negative viral loads\u002FRNA may be eligible).\n* Clinically unstable pleural or peritoneal effusion (stable cases after intervention are allowed).","ALL","19 Years",{"count":91,"type":92},62,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced\u002FMetastatic Non-Small Cell Lung Cancer Who Are Resistant or 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