[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604740":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":41,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":354,"collaborators":24,"id":356,"slug":24,"hasResults":357,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":357,"sex":363,"minAge":364,"maxAge":24,"enrollmentInfo":365,"targetDuration":24,"studyType":368,"phases":369,"briefSummary":371,"conditions":372,"keywords":376,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},{"fullName":5,"class":6},"Fundación GECP","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","From the date of randomization until end of follow up, up to 60 months.",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Resectability rate (%)","Resectability rate defined as the percentage of patients resected divided by the total number of patients who received neoadjuvant treatment.",{"measure":18,"description":19,"timeFrame":20},"Pathological complete response (pCR)","Pathological complete response (pCR) is defined as the absence of residual viable tumor on hematoxylin and eosin evaluation of the complete resected specimen","From the date of randomization until end of surgery, up to 6 months",{"measure":22,"description":23,"timeFrame":12},"Overall survival (OS)","Overall survival (OS) defined as the time which begins at the start of treatment and up to the time of death or last follow up",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","The study ATHENEA is a phase II clinical trial intending to enroll 97 patients, who will receive Atezolizumab + Paclitaxel + Carboplatin as induction\u002Fneoadjuvant treatment. After the induction treatment all patients will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.\n\nDepending on the decision each patient will be treated in a different way.\n\nThe study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer.\n\nThe primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population.\n\nProgression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death.\n\nThe total trial duration will be 10 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded.",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Experimental: Neoadjuvant\u002FInduction treatment","EXPERIMENTAL","Neoadjuvant\u002FInduction treatment prior to surgery:\n\n* Atezolizumab\n* Paclitaxel:\n* Carboplatin\n\nAfter assessment by a multidisciplinary team who will decide on the best post-induction treatment",[38,39,40],"Drug: Atezolizumab","Drug: Paclitaxel","Drug: Carboplatin",[42,49,55],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Atezolizumab","Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment\u002Fmedicine to manage potentially serious reactions.",[34],[48],"Tecentriq",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Paclitaxel","Neoadjuvant \u002F induction treatment:\n\nAtezolizumab Paclitaxel Carboplatin\n\nNeoadjuvant \u002F induction treatment 3 cycles will be administered prior to the assessment for surgery.\n\nRoute of administration Paclitaxel: Intravenous infusion.\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.",[34],[54],"Taxol",{"type":43,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Carboplatin","Neoadjuvant \u002F induction treatment:\n\nAtezolizumab Paclitaxel Carboplatin\\*\n\n\\*Infusion according to the standard of each center\n\nNeoadjuvant \u002F induction treatment 3 cycles will be administered prior to the assessment for surgery.\n\nRoute of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.",[34],[60],"Paraplatin",[62],{"name":63,"affiliation":64,"role":65},"Mariano Provencio, MD","President of Grupo Español de Cáncer de Pulmón","STUDY_CHAIR",[67],{"name":68,"role":69,"phone":70,"phoneExt":24,"email":71},"Eva Pereira","CONTACT","+34934302006","secretaria@gecp.org",[73,91,105,117,127,137,150,164,177,190,204,219,232,246,259,273,286,299,312,326,341],{"facility":74,"status":75,"city":76,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Hospital General Universitario Dr. Balmis de Alicante","RECRUITING","Alicante","03010","Spain","ES",{"type":81,"coordinates":82},"Point",[83,84],-0.48149,38.34517,{"lat":84,"lon":83},[87,89],{"name":88,"role":69,"phone":24,"phoneExt":24,"email":24},"Bartomeu Massuti, MD",{"name":88,"role":90,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":92,"status":75,"city":93,"state":94,"zip":95,"country":78,"countryCode":79,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"ICO Badalona, Hospital Germans Trias i Pujol","Badalona","Barcelona","08916",{"type":81,"coordinates":97},[98,99],2.24741,41.45004,{"lat":99,"lon":98},[102,104],{"name":103,"role":69,"phone":24,"phoneExt":24,"email":24},"Enric Carcereny, MD",{"name":103,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":106,"status":75,"city":94,"state":94,"zip":107,"country":78,"countryCode":79,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Universitari Vall d' Hebron","08035",{"type":81,"coordinates":109},[110,111],2.15899,41.38879,{"lat":111,"lon":110},[114,116],{"name":115,"role":69,"phone":24,"phoneExt":24,"email":24},"Alex Martínez, MD",{"name":115,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":118,"status":75,"city":94,"state":94,"zip":119,"country":78,"countryCode":79,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Hospital de la Santa Creu i Sant Pau","08041",{"type":81,"coordinates":121},[110,111],{"lat":111,"lon":110},[124,126],{"name":125,"role":69,"phone":24,"phoneExt":24,"email":24},"Sergio Martínez Recio, MD",{"name":125,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":128,"status":75,"city":94,"state":94,"zip":129,"country":78,"countryCode":79,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Hospital Parc Taulí","08208",{"type":81,"coordinates":131},[110,111],{"lat":111,"lon":110},[134,136],{"name":135,"role":69,"phone":24,"phoneExt":24,"email":24},"Laia Vilà, MD",{"name":135,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":138,"status":75,"city":139,"state":139,"zip":140,"country":78,"countryCode":79,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hospital De Basurto","Bilbao","48013",{"type":81,"coordinates":142},[143,144],-2.92528,43.26271,{"lat":144,"lon":143},[147,149],{"name":148,"role":69,"phone":24,"phoneExt":24,"email":24},"Mª Ángeles Sala, MD",{"name":148,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":151,"status":75,"city":152,"state":153,"zip":154,"country":78,"countryCode":79,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Hospital Univ. De Jerez De La Frontera","Jerez de la Frontera","Cadiz","11407",{"type":81,"coordinates":156},[157,158],-6.13606,36.68645,{"lat":158,"lon":157},[161,163],{"name":162,"role":69,"phone":24,"phoneExt":24,"email":24},"Mª Angeles Moreno, MD",{"name":162,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":165,"status":75,"city":166,"state":166,"zip":167,"country":78,"countryCode":79,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"ICO Girona, Hospital Josep Trueta","Girona","17007",{"type":81,"coordinates":169},[170,171],2.82493,41.98311,{"lat":171,"lon":170},[174,176],{"name":175,"role":69,"phone":24,"phoneExt":24,"email":24},"Elia Sais, MD",{"name":175,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":178,"status":75,"city":179,"state":179,"zip":180,"country":78,"countryCode":79,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hospital Universitario Clinico San Cecilio","Granada","18007",{"type":81,"coordinates":182},[183,184],-3.60667,37.18817,{"lat":184,"lon":183},[187,189],{"name":188,"role":69,"phone":24,"phoneExt":24,"email":24},"Silvia Sequero López, MD",{"name":188,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":191,"status":75,"city":192,"state":193,"zip":194,"country":78,"countryCode":79,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Hospitalario Universitario A Coruña","A Coruña","La Coruña","15006",{"type":81,"coordinates":196},[197,198],-8.396,43.37135,{"lat":198,"lon":197},[201,203],{"name":202,"role":69,"phone":24,"phoneExt":24,"email":24},"Rosario García Campelo, MD",{"name":202,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":205,"status":75,"city":206,"state":207,"zip":208,"country":78,"countryCode":79,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Hospital Universitari de Gran Canària Doctor Negrín","Las Palmas de Gran Canaria","Las Palmas","35010",{"type":81,"coordinates":210},[211,212],-15.41573,28.10178,{"lat":212,"lon":211},[215,217],{"name":216,"role":69,"phone":24,"phoneExt":24,"email":24},"David Aguiar Bujanda, MD",{"name":218,"role":90,"phone":24,"phoneExt":24,"email":24},"David Aguiar Bujanda",{"facility":220,"status":75,"city":221,"state":221,"zip":222,"country":78,"countryCode":79,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Hospital Universitario Lucus Augusti","Lugo","27003",{"type":81,"coordinates":224},[225,226],-7.55602,43.00992,{"lat":226,"lon":225},[229,231],{"name":230,"role":69,"phone":24,"phoneExt":24,"email":24},"Begoña Campos, MD",{"name":230,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":233,"status":234,"city":235,"state":235,"zip":236,"country":78,"countryCode":79,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Hospital Universitario Fundación Jiménez Díaz","NOT_YET_RECRUITING","Madrid","28040",{"type":81,"coordinates":238},[239,240],-3.70256,40.4165,{"lat":240,"lon":239},[243,245],{"name":244,"role":69,"phone":24,"phoneExt":24,"email":24},"Manuel Dómine, MD",{"name":244,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":247,"status":75,"city":248,"state":235,"zip":249,"country":78,"countryCode":79,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Hospital Universitario Puerta de Hierro","Majadahonda","28222",{"type":81,"coordinates":251},[252,253],-3.87182,40.47353,{"lat":253,"lon":252},[256,257],{"name":63,"role":69,"phone":24,"phoneExt":24,"email":24},{"name":258,"role":90,"phone":24,"phoneExt":24,"email":24},"Clara Salas, MD",{"facility":260,"status":75,"city":261,"state":261,"zip":262,"country":78,"countryCode":79,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Hospital Universitari Son Llatzer","Palma de Mallorca","07198",{"type":81,"coordinates":264},[265,266],2.65024,39.56939,{"lat":266,"lon":265},[269,271],{"name":270,"role":69,"phone":24,"phoneExt":24,"email":24},"Ester Gost, MD",{"name":272,"role":90,"phone":24,"phoneExt":24,"email":24},"Juan Coves Sarto, MD",{"facility":274,"status":75,"city":275,"state":275,"zip":276,"country":78,"countryCode":79,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Complejo Hospitalario de Navarra","Pamplona","31008",{"type":81,"coordinates":278},[279,280],-1.64323,42.81687,{"lat":280,"lon":279},[283,285],{"name":284,"role":69,"phone":24,"phoneExt":24,"email":24},"Maite Martínez, MD",{"name":284,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":287,"status":75,"city":288,"state":288,"zip":289,"country":78,"countryCode":79,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Hospital Universitario Salamanca","Salamanca","37007",{"type":81,"coordinates":291},[292,293],-5.66388,40.96882,{"lat":293,"lon":292},[296,298],{"name":297,"role":69,"phone":24,"phoneExt":24,"email":24},"Alejandro Olivares Hernández, MD",{"name":297,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":300,"status":75,"city":301,"state":301,"zip":302,"country":78,"countryCode":79,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Hospital Universitario Nuestra Señora La Candelaria","Santa Cruz de Tenerife","38009",{"type":81,"coordinates":304},[305,306],-16.25462,28.46824,{"lat":306,"lon":305},[309,311],{"name":310,"role":69,"phone":24,"phoneExt":24,"email":24},"Karla Mercedes Medina, MD",{"name":310,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":313,"status":75,"city":314,"state":315,"zip":316,"country":78,"countryCode":79,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Hospital Universitario Virgen Del Rocio","Seville","Sevilla","41013",{"type":81,"coordinates":318},[319,320],-5.97317,37.38283,{"lat":320,"lon":319},[323,325],{"name":324,"role":69,"phone":24,"phoneExt":24,"email":24},"Reyes Bernabé, MD",{"name":324,"role":90,"phone":24,"phoneExt":24,"email":24},{"facility":327,"status":75,"city":328,"state":329,"zip":330,"country":78,"countryCode":79,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Hospital Universitari Sant Joan de Reus","Reus","Tarragona","43204",{"type":81,"coordinates":332},[333,334],1.10687,41.15612,{"lat":334,"lon":333},[337,339],{"name":338,"role":69,"phone":24,"phoneExt":24,"email":24},"Clara Lucía Gozalvez, MD",{"name":340,"role":90,"phone":24,"phoneExt":24,"email":24},"Clara Lucía Gozalvez, Md",{"facility":342,"status":75,"city":343,"state":343,"zip":344,"country":78,"countryCode":79,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Hospital General Universitario de Valencia","Valencia","46014",{"type":81,"coordinates":346},[347,348],-0.37966,39.47391,{"lat":348,"lon":347},[351,353],{"name":352,"role":69,"phone":24,"phoneExt":24,"email":24},"Paula Espinosa, MD",{"name":352,"role":90,"phone":24,"phoneExt":24,"email":24},{"type":355,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100604740",false,"NCT07153445","Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)","Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy","ATHENEA","Inclusion Criteria:\n\n* Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)\n* Confirm the absence of distant disease\n* ECOG (Performance status) 0-1\n* Adequate hematologic and organ function\n* All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention\n* Adequate lung function\n* Patients aged \\> 18 years\n* For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception\n* For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form of contraception\n* Oral contraception should always be combined with an additional contraceptive method\n* Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.\n* Patient capable of proper therapeutic compliance and accessible for correct follow-up\n\nExclusion Criteria:\n\n* Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.\n* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.\n* Weight loss \\>10% within the previous 3 months.\n* Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.\n* Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment\n* Pleural or pericardial effusion\n* Known hypersensitivity or allergy to atezolizumab formulation.\n* History of autoimmune disease or lung disease\n* Positive test for human immunodeficiency viruses (HIV)\n* Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.\n* Active tuberculosis.\n* Symptomatic neuropathy grade \\> 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0\n* Severe infections within 4 weeks prior to be included in the study","ALL","18 Years",{"count":366,"type":367},97,"ESTIMATED","INTERVENTIONAL",[370],"PHASE2","This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.\n\nThe treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant\u002Finduction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.\n\nDepending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.",[373,374,375],"Non Small Cell Lung Cancer","Stage IIIA Lung Cancer","Stage IIIB Lung Cancer",[377,44,378,379],"Non small cell lung cancer","Non-resected lung cancer","Adjuvant treatment","2025-11-17",{"date":382,"type":383},"2025-11-19","ACTUAL",{"date":385,"type":383},"2025-07-08",{"date":387,"type":367},"2035-05-02",{"name":5,"class":6},21]