[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586607":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":42,"locations":49,"responsibleParty":310,"collaborators":47,"id":312,"slug":313,"hasResults":314,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":314,"sex":320,"minAge":321,"maxAge":47,"enrollmentInfo":322,"targetDuration":47,"studyType":325,"phases":326,"briefSummary":328,"conditions":329,"keywords":336,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},{"fullName":5,"class":6},"Fundación GECP","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","A. Cemiplimab monotherapy\n\n\\- Cemiplimab\n\nCemiplimab will be administered in monotherapy for 2 cycles. After 2 cycles of treatment and after response evaluation according to RECIST criteria and ctDNA quantification, patient will receive cemiplimab + chemotherapy or continue treatment with cemiplimab monotherapy\n\nCemiplimab monotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.\n\nB. Cemiplimab + chemotherapy\n\nThe treatment with chemotherapy will be selected according to investigator's choice. Carboplatin and Pemetrexed or Carboplatin plus taxanes is recommended.",[13,14,15],"Drug: Cemiplimab","Drug: Carboplatin","Drug: Paclitaxel",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cemiplimab","Patients will receive Cemiplimab administered by IV infusion over 30 minutes every 28 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.\n\nStructure: is a high affinity hinge-stabilized IgG4P human antibody to the PD-1receptor (PDCD1, CD279) that blocks PD 1\u002FPD L1 mediated T cell inhibition. Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.\n\nRoute of administration: Intravenous infusion.",[9],[23],"REGN2810",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Carboplatin","Patients will receive Carboplatin administered by IV infusion for 2 cycles.\n\nStructure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin.\n\nStability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin.\n\nRoute of administration: Intravenous infusion.",[9],[29,30],"Paraplatin","Carboplatine",{"type":18,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Paclitaxel","Patients will receive Paclitaxel administered by IV infusion for 2 cycles.\n\nStructure: A diterpene whose composition is: 5b, 20- epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.\n\nStability: Concentrations of 0.3-1.2 mg\u002Fml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately).\n\nThe intact vial must be stored between 15º and 25ºC.\n\nGuidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg\u002Fml.",[9],[36],"Taxol",[38],{"name":39,"affiliation":40,"role":41},"Mariano Provencio, MD","Fundación GECP President","STUDY_CHAIR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Eva Pereira","CONTACT","+34934302006",null,"secretaria@gecp.org",[50,68,81,95,107,117,130,143,158,172,186,201,215,227,236,246,261,274,284,297],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Hospital General de Alicante","RECRUITING","Alicante","03010","Spain","ES",{"type":58,"coordinates":59},"Point",[60,61],-0.48149,38.34517,{"lat":61,"lon":60},[64,66],{"name":65,"role":45,"phone":47,"phoneExt":47,"email":47},"Bartomeu Massutí, MD",{"name":65,"role":67,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"facility":69,"status":52,"city":70,"state":53,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospital General de Elche","Elche","03203",{"type":58,"coordinates":73},[74,75],-0.70107,38.26218,{"lat":75,"lon":74},[78,80],{"name":79,"role":45,"phone":47,"phoneExt":47,"email":47},"Javier David Benitez Fuentes, MD",{"name":79,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":82,"status":52,"city":83,"state":84,"zip":85,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"ICO Badalona, Hospital Germans Trias i Pujol","Badalona","Barcelona","08916",{"type":58,"coordinates":87},[88,89],2.24741,41.45004,{"lat":89,"lon":88},[92,94],{"name":93,"role":45,"phone":47,"phoneExt":47,"email":47},"Marc Cucurull, MD",{"name":93,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":96,"status":52,"city":84,"state":84,"zip":97,"country":55,"countryCode":56,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Hospital Universitari Vall d' Hebron","08035",{"type":58,"coordinates":99},[100,101],2.15899,41.38879,{"lat":101,"lon":100},[104,106],{"name":105,"role":45,"phone":47,"phoneExt":47,"email":47},"Patricia Iranzo, MD",{"name":105,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":108,"status":52,"city":84,"state":84,"zip":109,"country":55,"countryCode":56,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Hospital de la Santa Creu i Sant Pau","08041",{"type":58,"coordinates":111},[100,101],{"lat":101,"lon":100},[114,116],{"name":115,"role":45,"phone":47,"phoneExt":47,"email":47},"Sergio Martínez Recio, MD",{"name":115,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":118,"status":52,"city":119,"state":84,"zip":120,"country":55,"countryCode":56,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"ICO Hospitalet","L'Hospitalet de Llobregat","08908",{"type":58,"coordinates":122},[123,124],2.10028,41.35967,{"lat":124,"lon":123},[127,129],{"name":128,"role":45,"phone":47,"phoneExt":47,"email":47},"Ernest Nadal, MD",{"name":128,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":131,"status":52,"city":132,"state":132,"zip":133,"country":55,"countryCode":56,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Hospital De Basurto","Bilbao","48013",{"type":58,"coordinates":135},[136,137],-2.92528,43.26271,{"lat":137,"lon":136},[140,142],{"name":141,"role":45,"phone":47,"phoneExt":47,"email":47},"Mª Angeles Sala González, MD",{"name":141,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":144,"status":145,"city":146,"state":147,"zip":148,"country":55,"countryCode":56,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Hospital Universitario Jerez De La Frontera","NOT_YET_RECRUITING","Jerez de la Frontera","Cádiz","11407",{"type":58,"coordinates":150},[151,152],-6.13606,36.68645,{"lat":152,"lon":151},[155,157],{"name":156,"role":45,"phone":47,"phoneExt":47,"email":47},"Mª Ángeles Moreno, MD",{"name":156,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":159,"status":52,"city":160,"state":160,"zip":161,"country":55,"countryCode":56,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Hospital Dr. Josep Trueta","Girona","17007",{"type":58,"coordinates":163},[164,165],2.82493,41.98311,{"lat":165,"lon":164},[168,170],{"name":169,"role":45,"phone":47,"phoneExt":47,"email":47},"Joaquim Bosch, MD",{"name":171,"role":67,"phone":47,"phoneExt":47,"email":47},"Joaquim Bosch",{"facility":173,"status":52,"city":174,"state":175,"zip":176,"country":55,"countryCode":56,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Hospitalario Universitario A Coruña","A Coruña","La Coruña","15006",{"type":58,"coordinates":178},[179,180],-8.396,43.37135,{"lat":180,"lon":179},[183,185],{"name":184,"role":45,"phone":47,"phoneExt":47,"email":47},"Rosario García Campelo, MD",{"name":184,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":187,"status":52,"city":188,"state":189,"zip":190,"country":55,"countryCode":56,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Hospital Universitario Dr. Negrín","Las Palmas de Gran Canaria","Las Palmas","35010",{"type":58,"coordinates":192},[193,194],-15.41573,28.10178,{"lat":194,"lon":193},[197,199],{"name":198,"role":45,"phone":47,"phoneExt":47,"email":47},"David Aguiar, MD",{"name":200,"role":67,"phone":47,"phoneExt":47,"email":47},"David Aguiar",{"facility":202,"status":52,"city":203,"state":204,"zip":205,"country":55,"countryCode":56,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Hospital Universitario Severo Ochoa","Leganés","Madrid","28911",{"type":58,"coordinates":207},[208,209],-3.7635,40.32718,{"lat":209,"lon":208},[212,214],{"name":213,"role":45,"phone":47,"phoneExt":47,"email":47},"Ana López, MD",{"name":213,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":216,"status":52,"city":204,"state":204,"zip":217,"country":55,"countryCode":56,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Hospital Clínico San Carlos","28040",{"type":58,"coordinates":219},[220,221],-3.70256,40.4165,{"lat":221,"lon":220},[224,226],{"name":225,"role":45,"phone":47,"phoneExt":47,"email":47},"Carlos Aguado, MD",{"name":225,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":228,"status":52,"city":204,"state":204,"zip":217,"country":55,"countryCode":56,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Hospital Universitario Fundación Jiménez Díaz",{"type":58,"coordinates":230},[220,221],{"lat":221,"lon":220},[233,235],{"name":234,"role":45,"phone":47,"phoneExt":47,"email":47},"Manuel Dómine, MD",{"name":234,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":237,"status":52,"city":204,"state":204,"zip":238,"country":55,"countryCode":56,"cosmosGeoPoint":239,"geoPoint":241,"contacts":242},"Hospital Puerta de Hierro","28222",{"type":58,"coordinates":240},[220,221],{"lat":221,"lon":220},[243,245],{"name":244,"role":45,"phone":47,"phoneExt":47,"email":47},"Virginia Calvo, MD",{"name":244,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":247,"status":52,"city":248,"state":249,"zip":250,"country":55,"countryCode":56,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Hospital Universitario Son Espases","Palma de Mallorca","Mallorca","07120",{"type":58,"coordinates":252},[253,254],2.65024,39.56939,{"lat":254,"lon":253},[257,259],{"name":258,"role":45,"phone":47,"phoneExt":47,"email":47},"Raquel Marsé",{"name":260,"role":67,"phone":47,"phoneExt":47,"email":47},"Raquel Marsé, MD",{"facility":262,"status":52,"city":263,"state":263,"zip":264,"country":55,"countryCode":56,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Hospital Universitario Regional de Málaga","Málaga","29010",{"type":58,"coordinates":266},[267,268],-4.42034,36.72016,{"lat":268,"lon":267},[271,273],{"name":272,"role":45,"phone":47,"phoneExt":47,"email":47},"Vanesa Gutiérrez, MD",{"name":272,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":275,"status":52,"city":248,"state":248,"zip":276,"country":55,"countryCode":56,"cosmosGeoPoint":277,"geoPoint":279,"contacts":280},"Hospital Universitari Son Llatzer","07198",{"type":58,"coordinates":278},[253,254],{"lat":254,"lon":253},[281,283],{"name":282,"role":45,"phone":47,"phoneExt":47,"email":47},"Juan Coves Sarto, MD",{"name":282,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":285,"status":52,"city":286,"state":286,"zip":287,"country":55,"countryCode":56,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Hospital Universitario Salamanca","Salamanca","37007",{"type":58,"coordinates":289},[290,291],-5.66388,40.96882,{"lat":291,"lon":290},[294,296],{"name":295,"role":45,"phone":47,"phoneExt":47,"email":47},"Alejandro Olivares Hernández, MD",{"name":295,"role":67,"phone":47,"phoneExt":47,"email":47},{"facility":298,"status":52,"city":299,"state":299,"zip":300,"country":55,"countryCode":56,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Hospital General de Valencia","Valencia","46014",{"type":58,"coordinates":302},[303,304],-0.37966,39.47391,{"lat":304,"lon":303},[307,309],{"name":308,"role":45,"phone":47,"phoneExt":47,"email":47},"Paula Espinosa, MD",{"name":308,"role":67,"phone":47,"phoneExt":47,"email":47},{"type":311,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100586607","phase-2-palace-cemiplimab-trial-according-to-ctdna-levels-100586607",false,"NCT06917573","PALACE: Cemiplimab Trial According to ctDNA Levels","Phase II Clinical Trial With an Adaptive Design According to Response to Cemiplimab Monotherapy Using ctDNA and Subsequent Treatment With Chemotherapy (CT) and Cemiplimab or Cemiplimab Monotherapy in First Line Advanced NSCLC Patients","PALACE","Inclusion Criteria:\n\n* Histologically confirmed stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy\n* PDL1 ≥50%\n* ECOG performance status 0-1\n* Patients aged ≥ 18 years\n* Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment\n* Presence of at least one measurable lesion by CT-scan per RECIST version 1.1\n* Anticipated life expectancy \\>12 weeks\n* Correct hematological, hepatic and renal function\n* Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements\n* Patients must be accessible for treatment and follow-up\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.\n* All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs\n\nExclusion Criteria:\n\n* Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy\n* Patients with grade ≥2 neuropathy\n* Pregnant or breastfeeding women\n* Patients with a weight loss \\>10% within the previous 3 months\n* Patients with carcinomatous meningitis\n* Patients with a history of other malignant diseases within the past 3 years\n* Patients must have recovered from a major surgery at least 14 days prior to enrolment\n* Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol\n* Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria\n* Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy\n* Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n* Has known allergy or hypersensitivity to components of study drug\n* Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments\n* Untreated brain metastasis(es) that may be considered active\n* Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab\n* Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency\n* History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n* History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments\n* Patients with a history of solid organ transplant\n* Receipt of live vaccines within 30 days of first study treatment\n* Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.","ALL","18 Years",{"count":323,"type":324},63,"ESTIMATED","INTERVENTIONAL",[327],"PHASE2","This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.",[330,331,332,333,334,335],"Non Small Cell Lung Cancer Metastatic","Lung Diseases","Stage IV Non-small Cell Lung Cancer","Stage III Non-small Cell Lung Cancer","Respiratory Tract Neoplasms","Thoracic Neoplasms",[19,337,338,339],"ctDNA levels","Chemotherapy","Non-resectable non-small cell lung cancer","2025-11-17",{"date":342,"type":343},"2025-11-19","ACTUAL",{"date":345,"type":343},"2025-07-29",{"date":347,"type":324},"2031-12-30",{"name":5,"class":6},20]