[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594486":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":306,"collaborators":28,"id":308,"slug":309,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":28,"eligibilityCriteria":314,"healthyVolunteers":310,"sex":315,"minAge":316,"maxAge":28,"enrollmentInfo":317,"targetDuration":28,"studyType":320,"phases":321,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":55,"whyStopped":28,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":338,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Swiss Cancer Institute","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Non-squamous histology:\n\n* carboplatin IV AUC 3 day 1\n* pemetrexed IV 300 mg\u002Fm2 day 1\n* cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab with or without pemetrexed (at same dose and interval as above).\n\nSquamous histology:\n\n* carboplatin IV AUC 1.5 day 1, d8\n* gemcitabine IV 600 mg\u002Fm2 day 1, d8\n* cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab (350 mg q3w)\n\nAny histology:\n\n* carboplatin IV AUC 1.5 day 1, d8\n* paclitaxel IV 50 mg\u002Fm2 day 1, d8\n* cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab (350 mg q3w)",[13,14,15,16],"Drug: Cemiplimab","Drug: Carboplatin","Drug: Pemetrexed & Gemcitabine","Drug: Paclitaxel",{"label":18,"type":19,"description":20,"interventionNames":21},"Comparator arm","ACTIVE_COMPARATOR","cemiplimab IV 350 mg, day 1 Every 3 weeks (max. 2 years)",[13],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Cemiplimab","cemiplimab IV 350 mg, day 1",[18,9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Carboplatin","carboplatin IV AUC 3 day 1",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Pemetrexed & Gemcitabine","pemetrexed IV 300 mg\u002Fm2 day 1 gemcitabine IV 600 mg\u002Fm2 day 1, d8",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Paclitaxel","paclitaxel IV 50 mg\u002Fm2 day 1, d8",[9],[42],{"name":43,"affiliation":44,"role":45},"Laetitia Mauti, MD","Kantonsspital Winterthur KSW","STUDY_CHAIR",[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Gisela Müller","CONTACT","+41 31 389 91 91","trials@swisscancerinstitute.ch",[53,74,89,104,119,134,149,164,179,194,209,224,239,254,269,283,291],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"HFR Fribourg","RECRUITING","Fribourg","Villars-sur-Glâne","1752","Switzerland","CH",{"type":62,"coordinates":63},"Point",[64,65],7.15128,46.80237,{"lat":65,"lon":64},[68,72],{"name":69,"role":49,"phone":70,"phoneExt":28,"email":71},"Adrienne Bettini, MD","+41 26 426 72 43","adrienne.bettini@h-fr.ch",{"name":69,"role":73,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"facility":75,"status":55,"city":76,"state":28,"zip":77,"country":59,"countryCode":60,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Kantonsspital Aarau","Aarau","CH-5001",{"type":62,"coordinates":79},[80,81],8.04422,47.39254,{"lat":81,"lon":80},[84,88],{"name":85,"role":49,"phone":86,"phoneExt":28,"email":87},"Wolf-Dieter Janthur, MD","+41 62 838 55 80","wolf-dieter.janthur@ksa.ch",{"name":85,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":90,"status":55,"city":91,"state":28,"zip":92,"country":59,"countryCode":60,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Kantonsspital Baden","Baden","5404",{"type":62,"coordinates":94},[95,96],8.30592,47.47333,{"lat":96,"lon":95},[99,103],{"name":100,"role":49,"phone":101,"phoneExt":28,"email":102},"Sacha Rothschild, Prof","+41 56 486 27 62","sacha.rothschild@ksb.ch",{"name":100,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":105,"status":55,"city":106,"state":28,"zip":107,"country":59,"countryCode":60,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Universitätsspital Basel","Basel","4031",{"type":62,"coordinates":109},[110,111],7.57327,47.55839,{"lat":111,"lon":110},[114,118],{"name":115,"role":49,"phone":116,"phoneExt":28,"email":117},"Christian Frenzel, MD","+41 61 265 50 74","christian.frenzel@usb.ch",{"name":115,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":120,"status":55,"city":121,"state":28,"zip":122,"country":59,"countryCode":60,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Inselspital","Bern","3010",{"type":62,"coordinates":124},[125,126],7.44744,46.94809,{"lat":126,"lon":125},[129,133],{"name":130,"role":49,"phone":131,"phoneExt":28,"email":132},"Sabine Schmid, MD","+41 31 632 41 14","sabine.schmid@insel.ch",{"name":130,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":135,"status":55,"city":136,"state":28,"zip":137,"country":59,"countryCode":60,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Kantonsspital Baselland","Bruderholz","4101",{"type":62,"coordinates":139},[140,141],7.59902,47.5296,{"lat":141,"lon":140},[144,148],{"name":145,"role":49,"phone":146,"phoneExt":28,"email":147},"Claudia Ruth Bollinger, MD","+41 61 436 27 94","claudia.bollinger@ksbl.ch",{"name":145,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":150,"status":55,"city":151,"state":28,"zip":152,"country":59,"countryCode":60,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Kantonsspital Graubuenden","Chur","CH-7000",{"type":62,"coordinates":154},[155,156],9.53287,46.84986,{"lat":156,"lon":155},[159,163],{"name":160,"role":49,"phone":161,"phoneExt":28,"email":162},"Michael Thomas Mark, MD","+41 (0)81 256 61 11","michael.mark@ksgr.ch",{"name":160,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":165,"status":55,"city":166,"state":28,"zip":167,"country":59,"countryCode":60,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Spital Thurgau AG - Kantonsspital Frauenfeld","Frauenfeld","8501",{"type":62,"coordinates":169},[170,171],8.89893,47.55776,{"lat":171,"lon":170},[174,178],{"name":175,"role":49,"phone":176,"phoneExt":28,"email":177},"Ioannis Metaxas, MD","+41 52 723 78 50","ioannis.metaxas@stgag.ch",{"name":175,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":180,"status":55,"city":181,"state":28,"zip":182,"country":59,"countryCode":60,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Hôpitaux Universitaires de Genève","Geneva","1211",{"type":62,"coordinates":184},[185,186],6.14569,46.20222,{"lat":186,"lon":185},[189,193],{"name":190,"role":49,"phone":191,"phoneExt":28,"email":192},"Alfredo Addeo, MD","+41 79 553 50 35","alfredo.addeo@hcuge.ch",{"name":190,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":195,"status":55,"city":196,"state":28,"zip":197,"country":59,"countryCode":60,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Kantonsspital Olten - Solothurner Spitäler","Olten","4600",{"type":62,"coordinates":199},[200,201],7.90329,47.34999,{"lat":201,"lon":200},[204,208],{"name":205,"role":49,"phone":206,"phoneExt":28,"email":207},"Walter Mingrone, MD","+41 62 311 42 41","walter.mingrone@spital.so.ch",{"name":205,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":210,"status":55,"city":211,"state":28,"zip":212,"country":59,"countryCode":60,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Kantonsspital - St. Gallen","Sankt Gallen","CH-9007",{"type":62,"coordinates":214},[215,216],9.37477,47.42391,{"lat":216,"lon":215},[219,223],{"name":220,"role":49,"phone":221,"phoneExt":28,"email":222},"Martin Früh, MD","+41 71 494 10 68","martin.frueh@kssg.ch",{"name":220,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":225,"status":55,"city":226,"state":28,"zip":227,"country":59,"countryCode":60,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Hôpital du Valais - Sion","Sion","1951",{"type":62,"coordinates":229},[230,231],7.35559,46.22739,{"lat":231,"lon":230},[234,238],{"name":235,"role":49,"phone":236,"phoneExt":28,"email":237},"Alexandre Huber, MD","+41 27 603 18 34","alexandre.huber@hopitalvs.ch",{"name":235,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":240,"status":55,"city":241,"state":28,"zip":242,"country":59,"countryCode":60,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Spital Thun","Thun","3600",{"type":62,"coordinates":244},[245,246],7.62166,46.75118,{"lat":246,"lon":245},[249,253],{"name":250,"role":49,"phone":251,"phoneExt":28,"email":252},"Christoph Ackermann, MD","+41 58 636 26 45","christoph.ackermann@spitalstsag.ch",{"name":250,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":255,"status":55,"city":256,"state":28,"zip":257,"country":59,"countryCode":60,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"EOC Istituto Oncologico della Svizzera Italiana (IOSI)","Viganello","6962",{"type":62,"coordinates":259},[260,261],8.96879,46.01342,{"lat":261,"lon":260},[264,268],{"name":265,"role":49,"phone":266,"phoneExt":28,"email":267},"Jana Pankovics, MD","+41 76 371 62 92","jana.pankovics@eoc.ch",{"name":265,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":270,"status":55,"city":271,"state":28,"zip":272,"country":59,"countryCode":60,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Kantonsspital Winterthur","Winterthur","8401",{"type":62,"coordinates":274},[275,276],8.72413,47.50564,{"lat":276,"lon":275},[279,282],{"name":43,"role":49,"phone":280,"phoneExt":28,"email":281},"+41 52 266 23 73","laetitia.mauti@ksw.ch",{"name":43,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":284,"status":55,"city":271,"state":28,"zip":272,"country":59,"countryCode":60,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"KSW Kantonsspital Winterthur",{"type":62,"coordinates":286},[275,276],{"lat":276,"lon":275},[289,290],{"name":43,"role":49,"phone":280,"phoneExt":28,"email":281},{"name":43,"role":73,"phone":28,"phoneExt":28,"email":28},{"facility":292,"status":55,"city":293,"state":28,"zip":294,"country":59,"countryCode":60,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Stadtspital Zürich Triemli","Zurich","8063",{"type":62,"coordinates":296},[297,298],8.55,47.36667,{"lat":298,"lon":297},[301,305],{"name":302,"role":49,"phone":303,"phoneExt":28,"email":304},"Sebastian Kraus, MD","044 416 34 78","sebastian.kraus@stadtspital.ch",{"name":302,"role":73,"phone":28,"phoneExt":28,"email":28},{"type":307,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100594486","phase-2-reduced-dose-carboplatin-doublet-chemotherapy--cemiplimab-vs-cemiplimab-monotherapy-in-treatment-naive-older-and-frail-patients-with-metastatic-nsclc-with-pd-l1-50-100594486",false,"NCT07020065","Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 \u003C50%","Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 \u003C50% A Multicentre Randomized Open-label Phase II Trial","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Histologically or cytologically confirmed NSCLC. Mixed histology with small-cell component is not allowed.\n* Metastatic or advanced or recurrent NSCLC without a curative-intent treatment option (surgery or chemo-radiotherapy).\n* PD-L1 \\\u003C50% by local testing (SP 142 excluded)\n* ≥70 years\n* ECOG 0-2\n* G8 screening score of ≤14 and\u002For ineligible for full-dose chemotherapy, defined as doses of carboplatin AUC 5, pemetrexed 500 mg\u002Fm2, paclitaxel 175 mg\u002Fm2, gemcitabine 1200 mg\u002Fm2 (as per Investigator)\n* Life expectancy ≥6 months\n* Patients with a prior malignancy (except NSCLC, see EC 7.2.2 and 7.2.3) and treated with curative intent are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and\u002For no late recurrence, after consultation with CI.\n* Patients with asymptomatic untreated or symptomatic treated CNS metastases are eligible if corticosteroid dose \\\u003C10 mg prednisolone equivalent\u002Fday for at least 7 days\n* Patients must be suitable to receive reduced-dose carboplatin-doublet chemotherapy in combination with immunotherapy including adequate bone marrow, renal and hepatic function as follows:\n\n  * Hemoglobin ≥90 g\u002FL, neutrophils ≥1.5 G\u002FL, Thrombocytes ≥100G\u002FL\n  * Creatinine clearance (Cockroft-Gault) ≥30 mL\u002Fmin\n  * ASAT\u002FALAT ≤2xULN, Bilirubin ≤1.5xULN (≤3xULN for patients with Gilbert's disease),\n* Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last dose of trial treatment\n\nExclusion Criteria:\n\n* Actionable genomic alteration for 1L treatment (EGFR, ALK, ROS1, RET, NTRK, MET Exon14 skipping). Testing is required for any NSQ-NSCLC or patients with SCC and a smoking history of ≤10py.\n* Prior systemic treatment for metastatic NSCLC.\n* Prior chemotherapy and\u002For immunotherapy in curative-intent treatment for locally advanced NSCLC in the past 6 months.\n* Oligometastatic treatment concept with induction systemic therapy and planned LAT to all lesions.\n* High tumor burden with a risk of rapid critical progression, as judged by the Investigator. Careful patient selection is important in order to prevent that patients in the comparator arm are not eligible for receiving add-on reduced-dose chemotherapy anymore if primary progression occurs (e.g., pericardial infiltration, high liver metastasis load etc).\n* Active, treatment-requiring auto-immune disease in the past 2 years other than vitiligo, alopecia, hypothyroidism, type 1 diabetes or diet-controlled celiac disease.\n* History of pneumonitis in the past 5 years.\n* Systemic corticosteroid treatment ≥10 mg\u002Fday of prednisolone-equivalent or any other systemic immunosuppressive medication within 7 days prior to first dose of study intervention (except as needed for chemotherapy premedication or for physiologic corticosteroid replacement)\n* Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n* Uncontrolled infection with HIV, hepatitis B or hepatitis C infection\n* Receipt of a live vaccine within 4 weeks of start of study medication\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication\n* Organ transplant","ALL","70 Years",{"count":318,"type":319},156,"ESTIMATED","INTERVENTIONAL",[322],"PHASE2","Metastatic non-small cell lung cancer is often treated with a combination of chemotherapy and immunotherapy. In patients over the age of 70, some are already in poor health and frail, requiring assistance with daily activities, for example. Older and\u002For frail individuals often do not tolerate standard-dose chemotherapy well, and their risk of side effects is higher than that of younger patients.\n\nFor this reason, the SAKK 18\u002F24 study is investigating how effective and safe chemotherapy is in patients over 70 years of age when the chemotherapy drugs are administered at lower doses than usual. The aim of the study is to find a potentially effective and well-tolerated treatment for older people with metastatic non-small cell lung cancer.",[325],"Metastatic NSCLC - Non-Small Cell Lung Cancer",[327,25,328,329,330,331,332,333],"Reduced-dose chemotherapy","carboplatin","metastatic NSCLC","PD-L1 \u003C50%","Non-Small Cell Lung Cancer","older and frail patients","phase II","2026-04-10",{"date":336,"type":337},"2026-04-15","ACTUAL",{"date":334,"type":337},{"date":340,"type":319},"2030-09",{"name":5,"class":6},17]