[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AIO-Studien-gGmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,74,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100647804","phase-3-addition-of-platinum-based-chemotherapy-to-tislelizumab-in-pd-l1high-metastatic-non-small-cell-lung-cancer-with-a-high-tumor-burden-100647804",false,"NCT07715396","Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden","High Five","Inclusion Criteria:\n\n1. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study\n2. Histologically confirmed and treatment-naïve non-small cell lung cancer UICC 9th stage IV\n3. PD-L1 ≥ 50%\n4. High Tumor Burden defined as the longest diameter of the tumor or at least one metastasis ≥ 50mm and no eligibility for a curative treatment approach\n5. Measurable disease according to RECIST v1.1\n6. No actionable genomic alterations (AGA) qualifying for targeted first-line treatment\n7. Eligible for platinum-based chemoimmunotherapy\n8. Age ≥18 years\n9. Patients with brain metastases may be included, except when whole brain radiation therapy (WBRT) is pending. In such case, patients may be included 7 or more days after completion of WBRT.\n10. Female subjects of childbearing potential (FOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:\n\n    * Postmenopausal, defined as at least 12 months with no menses without an alternative medical cause; a follicle stimulating hormone (FSH) level in the postmenopausal range for the institution may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n    * have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, at least 6 weeks prior to screening (Women with tubal ligation are still considered of child-bearing potential according to CTFG Guidance).\n    * have a congenital or acquired condition that prevents childbearing Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n\nExclusion Criteria:\n\n1. Presence of a condition, disease or abnormality that in the opinion of the Investigator would compromise the safety of the patient, the patient's ability to comply with the study procedures (e.g., dementia) or the quality of the data. Specifically, the presence of any preexisting autoimmune disease that prohibits dosing of IMP as per treatment modification guidelines in the current IB\u002FSmPC\n2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study\n3. Concurrent malignancy other than NSCLC requiring active treatment\n4. Has known hypersensitivity to the IMPs or to any component of the planned regimen, their metabolites, or formulation excipients, or any other contraindication to any component of the planned study regimen according to the tislelizumab IB and the relevant SmPCs\n5. Current use of systemic corticosteroids that exceed 10 mg\u002Fday of prednisone or is equivalent medication within 3 days before the first dose of tislelizumab\u002Fpembrolizumab, except the following criterion:\n\n   \\- steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)\n6. Female subjects who are pregnant or breast-feeding or patients of reproductive potential who are not employing a highly effective method of birth control (failure rate of less than 1% per year)\n7. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities\n8. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts","ALL","18 Years",{"count":19,"type":20},230,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","AIO-TRK\u002FYMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.",[26],"Non-small Cell Lung Cancer Metastatic",[28,29,30,31,32,33],"Metastatic","Stage IV","NSCLC","High tumor burden","Immunotherapy","Platinum-based chemotherapy","NOT_YET_RECRUITING","2026-07-21",{"date":37,"type":38},"2026-07-22","ACTUAL",{"date":40,"type":20},"2026-10-30",{"date":42,"type":20},"2031-10-30",{"name":44,"class":45},"AIO-Studien-gGmbH","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100256852","clinical-research-platform-into-molecular-testing-treatment-and-outcome-of-non-small-cell-lung-carcinoma-patients-100256852","NCT02622581","Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients","CRISP","Inclusion Criteria:\n\nPatients who meet all of the following criteria are eligible for the project:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments\n\nMain project (Metatstatic NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\"\n* Stage IV, or stage IIIB\u002FC (UICC8) if patient is ineligible for curative surgery and\u002For radiochemotherapy\n* Systemic therapy or best supportive care\n\nSatellite Stage I\u002FII\u002FIII (NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Stage I, Stage II, stage IIIA, or stage IIIB\u002FC (UICC8)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nSatellite SCLC\n\n* Confirmed Small cell lung cancer (SCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nExclusion Criteria:\n\nnone",{"count":55,"type":20},12400,"3 Years","OBSERVATIONAL","Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany",[60,26,61,62,63,64],"Metastatic Non-small Cell Lung Cancer (NSCLC)","Non-small Cell Lung Cancer Stage II","Non Small Cell Lung Cancer Stage III","Small-cell Lung Cancer","Non-small Cell Lung Cancer Stage I","RECRUITING","2025-02-14",{"date":68,"type":38},"2025-02-18",{"date":70,"type":38},"2015-12",{"date":72,"type":20},"2027-12",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":57,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100493130","aio-bnho-comprehensive-clinico-genomics-database-network---aio-bnho-connect-100493130","NCT05701150","AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT","CONNECT","Inclusion Criteria:\n\n* Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and\u002For curative systemic therapy\n* Available results of commercial or non-commercial RNA- and\u002For DNA-based multi-gene NGS panels with \\>30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided\n* Age ≥ 18 years\n* Signed and dated informed consent form (not applicable for inclusion of deceased patients)\n\nExclusion Criteria:\n\n* Diagnosis of NSCLC\u002FSCLC (C34) or mesothelioma (C45)\n* NGS results older than two years at the date of patient inclusion",{"count":82,"type":20},3000,"36 Months","National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (\\>30 genes)",[86],"Advanced Solid Tumor","2025-02-13",{"date":89,"type":38},"2025-02-17",{"date":91,"type":38},"2022-12-08",{"date":93,"type":20},"2025-12",{"name":44,"class":45},3,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":83,"studyType":57,"phases":4,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100545344","head-and-neck-carcinoma-clinical-research-platform-for-molecular-and-blood-based-biomarkers-treatment-and-outcome-100545344","NCT06380686","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based","HEAT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written informed consent\n* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx)\n* Patients not amenable for curative treatment who receive palliative systemic treatment or best supportive care\n* Informed consent no later than four weeks after start of first-line palliative systemic treatment. For patients receiving \"best supportive care only\": no later than six weeks after diagnosis\u002Frecurrence or metastatic disease\n\nExclusion Criteria: none",{"count":105,"type":20},120,"Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent\u002Fmetastatic head and neck tumor patients.",[108,109,110,111],"Squamous Cell Carcinoma of the Oral Cavity","Squamous Cell Carcinoma of the Oropharynx","Squamous Cell Carcinoma of the Hypopharynx","Squamous Cell Carcinoma of the Larynx",[113],"SCCHN","2024-11-11",{"date":116,"type":38},"2024-11-13",{"date":118,"type":38},"2024-11-07",{"date":120,"type":20},"2030-11",{"name":44,"class":45},2,""]