[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489803":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":167,"collaborators":49,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":49,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":49,"enrollmentInfo":178,"targetDuration":49,"studyType":181,"phases":182,"briefSummary":184,"conditions":185,"keywords":191,"overallStatus":58,"whyStopped":49,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"L-SABR Arm","EXPERIMENTAL","Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR\u002FLiver Stereotactic Ablative Radiation Therapy.",[13,14,15],"Radiation: L-SABR","Biological: Anti-PD-(L)1 based immunotherapy","Drug: Platinum based chemotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Control Arm","ACTIVE_COMPARATOR","Participants randomized to the control arm will be treated according to the standard of care.",[14,15],[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","L-SABR","L-SABR will be delivered in a week during which the patient receives no chemotherapy. L-SABR can be on the same week or even day as anti-PD-(L)1 therapy.",[9],[28],"Liver Stereotactic Ablative Radiation Therapy",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Anti-PD-(L)1 based immunotherapy","Standard of care treatment (anti-PD-(L)1 based immunotherapy +\u002F- platinum based chemotherapy",[17,9],[35],"Standard of Care",{"type":37,"name":38,"description":32,"armGroupLabels":39,"otherNames":40},"DRUG","Platinum based chemotherapy",[17,9],[35],[42],{"name":43,"affiliation":5,"role":44},"Paul Romesser, MD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","646-888-2118",null,"romessep@mskcc.org",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Daniel Gomez, MD","212-639-2087","gomezd@mskcc.org",[56,74,87,98,109,121,132,142,153],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"BAPTIST ALLIANCE - MCI (Data Collection Only)","RECRUITING","Miami","Florida","33143","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-80.19366,25.77427,{"lat":68,"lon":67},[71],{"name":72,"role":47,"phone":73,"phoneExt":49,"email":49},"Adeel Kaiser, MD","786-596-2000",{"facility":75,"status":58,"city":76,"state":77,"zip":78,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920",{"type":65,"coordinates":80},[81,82],-74.54932,40.70621,{"lat":82,"lon":81},[85],{"name":86,"role":47,"phone":48,"phoneExt":49,"email":49},"Paul Romeser, MD",{"facility":88,"status":58,"city":89,"state":77,"zip":90,"country":62,"countryCode":63,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",{"type":65,"coordinates":92},[93,94],-74.11709,40.39428,{"lat":94,"lon":93},[97],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":99,"status":58,"city":100,"state":77,"zip":101,"country":62,"countryCode":63,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Memorial Sloan Kettering Bergen (All protocol activities)","Montvale","07645",{"type":65,"coordinates":103},[104,105],-74.02292,41.04676,{"lat":105,"lon":104},[108],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":110,"status":58,"city":111,"state":112,"zip":113,"country":62,"countryCode":63,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":65,"coordinates":115},[116,117],-73.29289,40.84288,{"lat":117,"lon":116},[120],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":122,"status":58,"city":123,"state":112,"zip":124,"country":62,"countryCode":63,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",{"type":65,"coordinates":126},[127,128],-73.71263,40.96899,{"lat":128,"lon":127},[131],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":133,"status":58,"city":112,"state":112,"zip":134,"country":62,"countryCode":63,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":65,"coordinates":136},[137,138],-74.00597,40.71427,{"lat":138,"lon":137},[141],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":143,"status":58,"city":144,"state":112,"zip":145,"country":62,"countryCode":63,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Memorial Sloan Kettering Nassau (All protocol activities)","Rockville Centre","11553",{"type":65,"coordinates":147},[148,149],-73.64124,40.65871,{"lat":149,"lon":148},[152],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":49},{"facility":154,"status":58,"city":155,"state":156,"zip":157,"country":62,"countryCode":63,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Lehigh Valley Health Network (Data Collection Only)","Allentown","Pennsylvania","18103",{"type":65,"coordinates":159},[160,161],-75.49018,40.60843,{"lat":161,"lon":160},[164],{"name":165,"role":47,"phone":166,"phoneExt":49,"email":49},"Dennis Sopka, MD","610-402-0700",{"type":168,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100489803","phase-2-a-study-of-targeted-radiation-therapy-in-people-with-non-small-cell-lung-cancer-nsclc-100489803",false,"NCT05657873","A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)","A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC","Inclusion Criteria:\n\n* Be greater than 18 years of age on day of signing informed consent.\n* Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1.\n\n  o Patients with recurrent metastatic NSCLC following prior durvalumab for stage III disease are eligible provided this is their first immunotherapy course for metastatic disease (i.e., the planned anti-PD-(L)1-based regimen represents first-line systemic therapy in the metastatic setting).\n* Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases\n* Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +\u002F- platinum based chemotherapy for at least 3 cycles\n\n  o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.\n* Have a performance status of 0-2 on the ECOG Performance Scale.\n* Liver function tests:\n\n  * Total Bilirubin ≤ 1.5 x ULN\n  * AST\u002F ALT ≤ 5 x ULN\n* Eligible for L- SABR to all liver metastases as determined by the treating radiation oncologist\n* Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count \\>200 cells\u002Fmicroliter within 28 days prior to registration\n\nExclusion Criteria:\n\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* Patients with prior external beam radiation therapy to the liver.\n* Patients with known active Hepatitis B or Hepatitis C.\n* Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.\n* Patients who are pregnant or breastfeeding\n* Men or women not using effective contraception.","ALL","18 Years",{"count":179,"type":180},68,"ESTIMATED","INTERVENTIONAL",[183],"PHASE2","The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy\u002FL-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer\u002FNSCLC.",[186,187,188,189,190],"Non Small Cell Lung Cancer","Non Small Cell Lung Cancer Metastatic","Non-small Cell Carcinoma","NSCLC","NSCLC Stage IV",[192,187,188,193,24,189,190,5,194],"non small cell lung cancer","liver stereotactic ablative radiotherapy","22-368","2026-05-06",{"date":197,"type":198},"2026-05-07","ACTUAL",{"date":200,"type":198},"2022-12-09",{"date":202,"type":180},"2026-12-09",{"name":5,"class":6},9]