[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610999":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":295,"collaborators":297,"id":301,"slug":302,"hasResults":303,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":29,"eligibilityCriteria":307,"healthyVolunteers":303,"sex":308,"minAge":309,"maxAge":29,"enrollmentInfo":310,"targetDuration":29,"studyType":313,"phases":314,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":321,"whyStopped":29,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},{"fullName":5,"class":6},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequencing arm","EXPERIMENTAL","Patients will receive SRS\u002FFSRT for all BM within ≤14 days from randomization, followed by 4 cycles of platinum-based chemotherapy combined with ivonescimab at 20 mg\u002Fkg every 3 weeks (Q3W). The systemic therapy will be followed by maintenance therapy with ivonescimab at 20 mg\u002Fkg plus pemetrexed (for patients with non-squamous NSCLC only) Q3W, for up to 2 years.",[13,14,15,16,17,18],"Drug: Ivonescimab","Drug: Carboplatin","Drug: Pemetrexed","Drug: Paclitaxel","Drug: Paclitaxel-albumin","Radiation: Stereotactic Radiosurgery (SRS) or Fractionated Stereotactic Radiotherapy (FSRT)",{"label":20,"type":10,"description":21,"interventionNames":22},"Systemic treatment alone arm","Patients will receive 4 cycles of platinum-based chemotherapy combined with ivonescimab 20 mg\u002Fkg Q3W, followed by maintenance ivonescimab 20 mg\u002Fkg with pemetrexed (pemetrexed non-squamous only) Q3W for a maximum of 2 years.",[13,14,15,16,17],[24,30,34,37,41,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Ivonescimab","ivonescimab iv at 20 mg\u002Fkg every 3 weeks",[9,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Carboplatin","For adenocarcinoma : Carboplatin area under the curve of 5 mg\u002FmL\u002Fmin (AUC 5) IV with pemetrexed 500 mg\u002Fm2 IV on day 1 every 21 days (Q3W) for 4 cycles",[9,20],{"type":25,"name":35,"description":32,"armGroupLabels":36,"otherNames":29},"Pemetrexed",[9,20],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":29},"Paclitaxel","For squamous cell carcinoma: Carboplatin AUC 6 mg\u002FmL\u002Fmin IV\u002F paclitaxel IV 200 mg\u002Fm2 on day 1 every 21 days (Q3W) for 4 cycles (or 175 mg\u002Fm2 on D1 for Asian participant) Q3W for 4 cycles",[9,20],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":29},"Paclitaxel-albumin","For squamous cell carcinoma: Carboplatin AUC 6 mg\u002FmL\u002Fmin IV\u002F albumin-bound paclitaxel 100 mg\u002Fm2 on D1, 8 and 15 Q3W for 4 cycles",[9,20],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":29},"RADIATION","Stereotactic Radiosurgery (SRS) or Fractionated Stereotactic Radiotherapy (FSRT)","Patients will receive SRS\u002FFSRT for all BM within ≤14 days from randomization, followed by 4 cycles of platinum-based chemotherapy combined with ivonescimab at 20 mg\u002Fkg every 3 weeks (Q3W). The systemic therapy should be initiated within 7 to 10 days after the end of SRS\u002FFSRT but no earlier than 3 days after its completion. This will be followed by maintenance therapy with ivonescimab at 20 mg\u002Fkg plus pemetrexed (for patients with non-squamous NSCLC only) Q3W, for up to 2 years.",[9],[51],{"name":52,"affiliation":53,"role":54},"Lizza Hendriks, MD, PhD","Maastricht UMC","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":29,"email":60},"EORTC HQ","CONTACT","+32 2 774611","eortc@eortc.org",[62,74,83,94,103,112,121,130,141,150,159,170,176,181,191,199,208,214,223,233,241,249,260,269,280,286],{"facility":63,"status":29,"city":64,"state":29,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":29},"Kepler University Hospital","Linz","4021","Austria","AT",{"type":69,"coordinates":70},"Point",[71,72],14.28611,48.30639,{"lat":72,"lon":71},{"facility":75,"status":29,"city":76,"state":29,"zip":77,"country":66,"countryCode":67,"cosmosGeoPoint":78,"geoPoint":82,"contacts":29},"Medical University of Vienna","Vienna","1090",{"type":69,"coordinates":79},[80,81],16.37208,48.20849,{"lat":81,"lon":80},{"facility":84,"status":29,"city":85,"state":29,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":29},"CLCC-Jean Perrin","Clermont-Ferrand","63000","France","FR",{"type":69,"coordinates":90},[91,92],3.08682,45.77969,{"lat":92,"lon":91},{"facility":95,"status":29,"city":96,"state":29,"zip":97,"country":87,"countryCode":88,"cosmosGeoPoint":98,"geoPoint":102,"contacts":29},"Centre Leon Berard","Lyon","69373",{"type":69,"coordinates":99},[100,101],4.84789,45.74906,{"lat":101,"lon":100},{"facility":104,"status":29,"city":105,"state":29,"zip":106,"country":87,"countryCode":88,"cosmosGeoPoint":107,"geoPoint":111,"contacts":29},"Centre Antoine Lacassagne","Nice","06189",{"type":69,"coordinates":108},[109,110],7.26608,43.70313,{"lat":110,"lon":109},{"facility":113,"status":29,"city":114,"state":29,"zip":115,"country":87,"countryCode":88,"cosmosGeoPoint":116,"geoPoint":120,"contacts":29},"Institut Godinot","Reims","51056",{"type":69,"coordinates":117},[118,119],4.02853,49.26526,{"lat":119,"lon":118},{"facility":122,"status":29,"city":123,"state":29,"zip":124,"country":87,"countryCode":88,"cosmosGeoPoint":125,"geoPoint":129,"contacts":29},"Gustave Roussy","Villejuif","t 94805",{"type":69,"coordinates":126},[127,128],2.35992,48.7939,{"lat":128,"lon":127},{"facility":131,"status":29,"city":132,"state":29,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":29},"University Hospital Frankfurt -Senckenberg Institute of Neurooncology","Frankfurt am Main","60590","Germany","DE",{"type":69,"coordinates":137},[138,139],8.68417,50.11552,{"lat":139,"lon":138},{"facility":142,"status":29,"city":143,"state":29,"zip":144,"country":134,"countryCode":135,"cosmosGeoPoint":145,"geoPoint":149,"contacts":29},"Universitaetsklinikum Jena","Jena","07447",{"type":69,"coordinates":146},[147,148],11.5899,50.92878,{"lat":148,"lon":147},{"facility":151,"status":29,"city":152,"state":29,"zip":153,"country":134,"countryCode":135,"cosmosGeoPoint":154,"geoPoint":158,"contacts":29},"Univ. Rostock-Zentrum für Radiologie mit Klinik und Poliklinik für Strahlentherapi","Rostock","18058",{"type":69,"coordinates":155},[156,157],12.14049,54.0887,{"lat":157,"lon":156},{"facility":160,"status":29,"city":161,"state":29,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":29},"General hospital of Athens 'Alexandra'","Athens","11528","Greece","GR",{"type":69,"coordinates":166},[167,168],23.72784,37.98376,{"lat":168,"lon":167},{"facility":171,"status":29,"city":161,"state":29,"zip":172,"country":163,"countryCode":164,"cosmosGeoPoint":173,"geoPoint":175,"contacts":29},"Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.","151 23",{"type":69,"coordinates":174},[167,168],{"lat":168,"lon":167},{"facility":177,"status":29,"city":161,"state":29,"zip":29,"country":163,"countryCode":164,"cosmosGeoPoint":178,"geoPoint":180,"contacts":29},"Metropolitan Hospital",{"type":69,"coordinates":179},[167,168],{"lat":168,"lon":167},{"facility":182,"status":29,"city":183,"state":29,"zip":29,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":29},"Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia","Brescia","Italy","IT",{"type":69,"coordinates":187},[188,189],10.21472,45.53558,{"lat":189,"lon":188},{"facility":192,"status":29,"city":193,"state":29,"zip":29,"country":184,"countryCode":185,"cosmosGeoPoint":194,"geoPoint":198,"contacts":29},"RCCS Ospedale San Raffaele","Milan",{"type":69,"coordinates":195},[196,197],12.59836,42.78235,{"lat":197,"lon":196},{"facility":200,"status":29,"city":201,"state":29,"zip":202,"country":184,"countryCode":185,"cosmosGeoPoint":203,"geoPoint":207,"contacts":29},"Policlinico Universitario Campus Bio-Medico- Oncology Center","Roma","00128",{"type":69,"coordinates":204},[205,206],11.10642,44.99364,{"lat":206,"lon":205},{"facility":209,"status":29,"city":201,"state":29,"zip":210,"country":184,"countryCode":185,"cosmosGeoPoint":211,"geoPoint":213,"contacts":29},"Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola","00186",{"type":69,"coordinates":212},[205,206],{"lat":206,"lon":205},{"facility":215,"status":29,"city":216,"state":29,"zip":217,"country":184,"countryCode":185,"cosmosGeoPoint":218,"geoPoint":222,"contacts":29},"Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario \"Santa Maria della Misericordia\" )","Udine","33100",{"type":69,"coordinates":219},[220,221],13.23715,46.0693,{"lat":221,"lon":220},{"facility":224,"status":29,"city":225,"state":29,"zip":29,"country":226,"countryCode":227,"cosmosGeoPoint":228,"geoPoint":232,"contacts":29},"Academisch Ziekenhuis Maastricht","Maastricht","Netherlands","NL",{"type":69,"coordinates":229},[230,231],5.68889,50.84833,{"lat":231,"lon":230},{"facility":234,"status":29,"city":235,"state":29,"zip":29,"country":226,"countryCode":227,"cosmosGeoPoint":236,"geoPoint":240,"contacts":29},"Erasmuc Mc","Rotterdam",{"type":69,"coordinates":237},[238,239],4.47917,51.9225,{"lat":239,"lon":238},{"facility":242,"status":29,"city":243,"state":29,"zip":29,"country":226,"countryCode":227,"cosmosGeoPoint":244,"geoPoint":248,"contacts":29},"UMC-Academisch Ziekenhuis Utrecht","Utrecht",{"type":69,"coordinates":245},[246,247],5.12222,52.09083,{"lat":247,"lon":246},{"facility":250,"status":29,"city":251,"state":29,"zip":252,"country":253,"countryCode":254,"cosmosGeoPoint":255,"geoPoint":259,"contacts":29},"University Clinic Golnik","Golnik","4204","Slovenia","SI",{"type":69,"coordinates":256},[257,258],14.33333,46.33333,{"lat":258,"lon":257},{"facility":261,"status":29,"city":262,"state":29,"zip":263,"country":253,"countryCode":254,"cosmosGeoPoint":264,"geoPoint":268,"contacts":29},"The Institute Of Oncology","Ljubljana","1000",{"type":69,"coordinates":265},[266,267],14.50513,46.05108,{"lat":267,"lon":266},{"facility":270,"status":29,"city":271,"state":29,"zip":272,"country":273,"countryCode":274,"cosmosGeoPoint":275,"geoPoint":279,"contacts":29},"Hospital Universitario de La Princesa","Madrid","28006","Spain","ES",{"type":69,"coordinates":276},[277,278],-3.70256,40.4165,{"lat":278,"lon":277},{"facility":281,"status":29,"city":271,"state":29,"zip":282,"country":273,"countryCode":274,"cosmosGeoPoint":283,"geoPoint":285,"contacts":29},"Hospital Universitario 12 De Octubre","28041",{"type":69,"coordinates":284},[277,278],{"lat":278,"lon":277},{"facility":287,"status":29,"city":288,"state":29,"zip":289,"country":273,"countryCode":274,"cosmosGeoPoint":290,"geoPoint":294,"contacts":29},"Hospital Universitari Son Espases","Palma de Mallorca","07120",{"type":69,"coordinates":291},[292,293],2.65024,39.56939,{"lat":293,"lon":292},{"type":296,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[298],{"name":299,"class":300},"Summit Therapeutics","INDUSTRY","100610999","phase-2-phase-ii-study-of-upfront-srt-plus-ivonescimabchemotherapy-vs-ivonescimabchemotherapy-in-nsclc-brain-mets-100610999",false,"NCT07234877","Phase II Study of Upfront SRT Plus Ivonescimab\u002FChemotherapy vs Ivonescimab\u002FChemotherapy in NSCLC Brain Mets","A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC","Inclusion Criteria:\n\n* Age 18 years or older\n* ECOG PS \\\u003C= 2\n* Patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment approved by EMA and recommended by the ESMO guidelines.\n* Asymptomatic or clinically symptomatic brain metastases defined as requiring a dose of steroids of maximum 4 mg equivalent dexamethasone per day for the last 7 days to control neurological symptoms. With the clinically oligosymptomatic further defined as having no indication for immediate localized brain therapy, including neurosurgery or radiotherapy. Patients with controlled seizures can be enrolled.\n* Newly diagnosed brain metastasis with the following characteristics:\n\n  * 1-10 newly diagnosed and untreated (except resected) brain metastases Note: if the neuronavigation MRI in the upfront SRS\u002FFSRT arms shows \\> 10 metastases, but the MRI used for enrolment showed 1-10 metastases, the patient will be still considered eligible.\n  * At least one metastasis should be at least 5x5 mm. In case of doubt on the diagnosis of brain metastasis, the lesion should not be irradiated but followed up.\n  * The largest metastasis must be \\\u003C10 mL in volume and \\\u003C30 mm in longest diameter (resected lesions would not count).\n  * The maximum cumulative volume of brain metastases must be \\\u003C30 mL (resected lesions would not count)\n* Adequate Organ Function\n\nExclusion Criteria:\n\n* Patients with oligometastatic NSCLC who are scheduled to receive radical local treatment to extra-cranial sites.\n* Patients with contra-indications to brain MRI with gadolinium-based contrast agent.\n* Active auto-immune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Patients with \\>30 Gy of chest radiation therapy within 6 months prior to randomization; non-thoracic radiation therapy \\>30Gy within 4 weeks prior to randomization, or palliative radiation therapy of ≤30 Gy within 7 days prior to randomization.\n* Prior brain irradiation (including whole brain radiotherapy and SRS).\n* Prior systemic treatment for metastatic NSCLC. Patients having received adjuvant or neoadjuvant chemotherapy or curative-intent chemoradiotherapy with or without PD-1\u002FL1 inhibitors can be enrolled if the adjuvant\u002Fneoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.\n* History of coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* History of serious cardiovascular, gastronintestinal, thromboembolic, neurological, or pulmonary conditions before randomization.\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization","ALL","18 Years",{"count":311,"type":312},158,"ESTIMATED","INTERVENTIONAL",[315],"PHASE2","This is a randomized, two-arm, comparative Phase II clinical trial designed to evaluate the difference in intracranial progression-free survival (iPFS) between two treatment strategies, assessed locally.\n\nApproximately 158 patients will be randomized in a 1:1 ratio. Will be included patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment available and active asymptomatic brain metastasis (newly diagnosed or progressive).\n\nThe primary objective is to compare iPFS between the two arms.",[318],"Non Small Cell Lung Cancer",[26,320],"Phase II study","NOT_YET_RECRUITING","2026-06-02",{"date":324,"type":325},"2026-06-04","ACTUAL",{"date":327,"type":312},"2026-11",{"date":329,"type":312},"2032-04",{"name":5,"class":6},26]