[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Swiss Cancer Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":371},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,45,84,116,152,183,213,240,267,293,320,346],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100546977","phase-2-darolutamide-in-metastatic-castration-resistant-prostate-cancer-mcrpc-100546977",false,"NCT06401980","Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures\n* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate\n* Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists).\n* Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial\n* Metastatic disease, documented by imaging according to PCWG3 criteria\n* Measurable disease or bone lesions that are evaluable according to PCWG3 criteria\n* A minimum of 12 months on ADT+ARPI therapy (calculated from ADT initiation) within mHSPC setting, showing an at least 50% PSA response or partial remission according to RECIST v1.1. ARPI change within mHSPC is only allowed for intolerance.\n* Progressive disease according to modified PCWG3 before registration is defined as (at least 2 out of 3):\n\n  * PSA progression ≥ 25% above nadir (2 consecutive rises at least 3 weeks apart)\n  * New metastatic lesion on imaging (at least two or more new bone lesions on bone scan or one new non-bone lesion or progression on PSMA-PET\u002FCT according to PROMISE V2 criteria\n  * Clinical progression\n* Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.0 x 109\u002FL, platelet count ≥ 100 x 109\u002FL, hemoglobin ≥ 90 g\u002FL.\n* Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), ALT and AST ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of cancer\n* Adequate renal function: estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula)\n* Men agree not to donate sperm or to father a child during trial treatment and until 3 months after the last dose of trial treatment\n* Patients are able and willing to swallow darolutamide as whole tablet.\n\nExclusion Criteria:\n\n* Presence of a small cell component\n* Prior systemic therapy for metastatic castration-resistant disease\n* Prior chemotherapy for mHSPC, except docetaxel\n* Prior LuPSMA or radium 223 for prostate cancer\n* Concomitant or recent (within 28 days of registration) treatment with any other experimental drug\n* Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues\n* Severe or uncontrolled cardiovascular disease\n* Acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days before expected start of treatment\n* Clinical or radiological evidence of current spinal cord compression\n* Any concomitant drugs contraindicated for use with darolutamide according to the approved product information\n* Known hypersensitivity to darolutamide\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.","MALE","18 Years",{"count":19,"type":20},162,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Despite improvements in treatment, metastatic prostate cancer remains incurable, especially in the case of pretreated metastatic castration-resistant disease (mCRPC), where treatment options are limited, leading to an unmet need. The paradigm shift in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has affected the treatment landscape for mCRPC patients. Many have already received androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), making first-line mCRPC treatment challenging.\n\nThe Swiss Group for Clinical Cancer Research (SAKK) has shown in previous studies that maintenance treatment with an ARPI, such as darolutamide, can improve radiographic progression-free survival (rPFS) in pretreated mCRPC patients. In the SAKK 08\u002F16 trial, darolutamide maintenance was found to prolong PFS compared to placebo, especially in patients who responded well to prior ARPI treatment.\n\nBased on these findings, the hypothesis is that continued AR-pathway blockade with darolutamide, initiated in patients progressing from mHSPC to mCRPC on ARPI treatment, can improve outcomes when added to standard first-line mCRPC therapy and continued as maintenance. The proposed study aims to evaluate the efficacy of darolutamide, combined with physician-choice standard of care (including taxane chemotherapy, olaparib, radium 223, or LuPSMA), followed by maintenance therapy, on rPFS for patients in the first-line setting of mCRPC.",[26],"Metastatic Castration-resistant Prostate Cancer",[28,29,30,31],"Metastatic Castration-Resistant Prostate Cancer","mCRPC","Darolutamide","phase II trial","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2024-10-22",{"date":40,"type":20},"2030-09",{"name":42,"class":43},"Swiss Cancer Institute","OTHER",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":5},"100637435","primary-and-acquired-resistance-to-targeted-treatment-in-braf-v600e-mutated-metastatic-colorectal-cancer-100637435","NCT07617610","Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer","Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer (PARTACER-Suisse)","PARTACER","Inclusion Criteria:\n\n* Diagnosis of unresectable or metastatic BRAF V600E-mutated colorectal cancer\n* Planned initiation of treatment with combined anti-EGFR antibody and BRAF inhibitor\n* Patients receiving treatment in any line, with or without chemotherapy\n* At least one tumor lesion accessible for biopsy\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months\n* Age ≥18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Medical or surgical contraindication for tumor biopsy\n* Active second malignancy (except non-melanoma skin cancer)\n* Inability to comply with study procedures (e.g., due to language barriers or cognitive impairment)\n* Pregnancy or breastfeeding\n* Previous treatment with a BRAF inhibitor","ALL",{"count":55,"type":20},30,"OBSERVATIONAL","This study prospectively investigates the molecular mechanisms of primary and acquired resistance to standard-of-care BRAF V600E-directed therapy in patients with metastatic colorectal cancer and aims to pre-clinically develop novel strategies to reverse therapy resistance. Clinically approved combination treatment with cetuximab, encorafenib and chemotherapy improves patient outcomes, yet patients eventually experience disease progression. In this prospective multicenter study, tumor tissue, blood, and stool samples will be collected before treatment and at progression, to identify genetic and non-genetic mechanisms of resistance. Additionally, tumor tissue-based in vitro models (patient-derived organoids, PDOs) will be generated and exploited for functional in vitro testing, including genomic and pharmacologic perturbation studies. The overarching goal is to generate knowledge that can help develop new and more effective treatment strategies for future patients.",[59,60],"Metastatic Colorectal Cancer","BRAF V600E Mutation",[59,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"mCRC","BRAF V600E","Targeted therapy resistance","Encorafenib","Cetuximab","EGFR inhibition","BRAF inhibition","Liquid biopsy","Precision oncology","Patient-derived organoids","Circulating tumor DNA","ctDNA","Microbiome","Comprehensive genomic profiling","SCI\u002FSAKK","2026-05-22",{"date":79,"type":36},"2026-06-01",{"date":81,"type":36},"2025-05-25",{"date":40,"type":20},{"name":42,"class":43},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100640264","phase-2-bendamustine-versus-fludarabinecyclophosphamide-for-lymphodepletion-in-chimeric-antigen-receptor-t-cell-immunotherapy-car-t-a-randomized-trial-100640264","NCT07593482","Bendamustine Versus Fludarabine\u002FCyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.","Bendamustine Versus Fludarabine\u002FCyclophosphamide for Lymphodepletion in CAR-T Therapy: a Randomized Trial","FC-BALANCE","Inclusion Criteria:\n\n* Diagnosis of large B-cell lymphoma (LBCL) with at least one line of previous treatment and indication for commercial CAR-T cell therapy as determined by the treating physician. This includes: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) and all specific DLBCL subtypes, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma, and other transformed indolent B-cell lymphomas (including transformed marginal zone lymphoma and Richter's transformation). Patients with primary or secondary central nervous system (CNS) involvement are eligible.\n* Planned treatment with commercially available CAR-T cell product\n* Age ≥18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Administration of any other experimental drug within 5 half-lives or ≤ 4 weeks prior to lymphodepletion therapy starts.\n* Bendamustine 3 months before leukapheresis. After leukapheresis, bendamustine use is allowed as bridging therapy according to physician decision.\n* Previous administration of anti-CD19 CAR-T products within the last 12 months from lymphodepletion therapy start.\n* Known history of hypersensitivity to the active substance or any of the excipients found in the composition of bendamustine, fludarabine, or cyclophosphamide.",{"count":93,"type":20},92,[23],"Bendamustine and the combination of fludarabine\u002Fcyclophosphamide are fully authorized chemotherapy agents in Switzerland for lymphoma treatment and currently used in routine clinical practice as lymphodepletion strategy before CAR-T immunotherapy, as supported by retrospective studies and clinical experience across multiple centers. None of the drugs described in this protocol are being used at unapproved doses, or in an investigational formulation. Both lymphodepletion regimens have a known safety profile and the risks and burdens imposed on participants do not exceed those encountered in routine CAR-T therapy management, as all procedures (including monitoring, supportive care, and follow-up assessments) align with standard clinical practice. Based on these assumptions, this protocol is designed to investigate the use of bendamustine as an alternative lymphodepletion therapy (which is a part of CAR-T immunotherapy protocol).",[97],"B-cell Lymphoma",[99,100,101,102,103,104,105],"Large B-cell lymphoma","LBCL","B-cell malignancy","Chimeric antigen receptor (CAR) T-cell therapy","Bendamustine","Fludarabine\u002FCyclophosphamide","lymphodepletion in CAR-T therapy","NOT_YET_RECRUITING","2026-05-13",{"date":109,"type":36},"2026-05-18",{"date":111,"type":20},"2026-09",{"date":113,"type":20},"2030-03",{"name":42,"class":43},9,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100638950","phase-4-melchrono-a-prospective-randomized-study-investigating-chrono-immunotherapy-for-advanced-melanoma-100638950","NCT07574047","MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma.","MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma. A Phase IV Trial.","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures.\n* Histologically confirmed unresectable cutaneous stage III or stage IV melanoma. Note: Participants with central nervous system (CNS) metastases are eligible.\n* Participants with a previously treated other malignancy are eligible, if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low.\n* Measurable or evaluable disease.\n* Age ≥ 18 years.\n* Patients deemed suitable for ICI therapy based on the local investigator's clinical assessment.\n* ECOG performance status 0-2.\n* Women of childbearing potential must use effective contraception , not be pregnant or lactating and agree not to become pregnant during trial treatment and until 5 months after the last dose of trial treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.\n* Men agree not to donate sperm or to father a child during trial treatment and until 5 months after the last dose of trial treatment.\n\nExclusion Criteria:\n\n* Prior treatment with any systemic anti-cancer therapy; with the exception of prior adjuvant anti-PD-1 or BRAF\u002FMEK inhibitor therapy if the time from last dose to recurrence is more than 6 months.\n* Recent treatment (within 28 days prior to first dose) with any experimental drug.\n* Known history of allogeneic organ transplant.\n* Uveal or mucosal melanoma.\n* Receipt of live attenuated vaccine within 28 days prior to first dose.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information.\n* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect participant compliance or place the participant at high risk from treatment-related complications.",{"count":124,"type":20},108,[126],"PHASE4","Melanoma remains a common cancer with rising incidence, and despite significant improvements with immune checkpoint inhibitors (ICIs), clinical outcomes remain heterogeneous. Retrospective analyses across multiple tumor types, including melanoma, suggest that earlier daytime administration of ICIs may enhance therapeutic effectiveness, potentially due to circadian modulation of immune function. A pronounced survival benefit has been observed particularly among female patients receiving earlier infusions. This trial prospectively evaluates whether aligning ICI administration with circadian immune activity can improve outcomes in melanoma and support the development of sex-specific optimization of immunotherapy.",[129,130],"Melanoma","Advanced Melanoma",[132,133,134,135,136,137,138,139,140,141,142,143],"Advanced melanoma","chrono-immunotherapy","phase IV","Nivolumab","Ipilimumab","relatlimab","Pembrplizumab","Opdivo","Keytruda","Opdualag","Yervoy","immune checkpoint inhibitor","2026-05-01",{"date":146,"type":36},"2026-05-07",{"date":111,"type":20},{"date":149,"type":20},"2032-06",{"name":42,"class":43},8,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100605128","phase-2-overcoming-resistance-to-immunotherapy-combining-gemcitabine-with-ivonescimab-in-advanced-nsclc-100605128","NCT07158489","Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC","Protocol SAKK 18\u002F 25 Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC Progressing on Immune Checkpoint Inhibitors: A Multicenter, Single-arm, Open-label Phase II Trial (ORIGIN2)","ORIGIN2","Inclusion Criteria:\n\n* Patients fulfilling all of the following inclusion criteria are eligible for the trial:\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures including patient screening.\n* Confirmed squamous or non-squamous mNSCLC stage IIIB-IV (based on 9th edition Tumor-Node-Metastasis (TNM) classification of lung cancers with disease recurrence or progression during or after one or more prior immunotherapy or CIT regimens for metastatic disease.\n* Patients with treated and stable central nervous system (CNS) metastases are eligible, if:\n\n  * Previous CNS-directed therapy has been completed at least 4 weeks prior to treatment start.\n  * No evidence of progression after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging with Magnetic Resonance Imaging (MRI) or CT.25\n* Patients with known HIV-infection are eligible, if:\n\n  * CD4+ T-cell counts are ≥ 350 cells\u002Fµl\n  * No history of AIDS-defining opportunistic infection within past 12 months\n  * Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, or is on ART for ˃ 4 weeks and has a HIV viral load ˂ 400 copies\u002Fml.26\n* Patients with a previously treated malignancy are eligible if this is clinically stable and does not require concurrent tumor-directed treatment.\n\nException: patients suffering from prostate cancer under hormonal ablation therapy (hormone sensitive disease).\n\n* Patients with measurable disease according to RECIST v1.1.\n* Availability of newly collected or archival (maximum 3 months) samples for TR prior to treatment initiation.\n* Age ≥ 18 years\n* ECOG performance status 0-2.\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109\u002Fl, platelet count ≥ 100 x 109\u002Fl, hemoglobin ≥ 90 g\u002Fl.\n\n6.1.11 Adequate hepatic function: total bilirubin ≤ 1.5 x upper limit of normal (\\[ULN\\]; except for patients with Gilbert's disease ≤ 3.0 x ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN for patients with hepatic metastasis.\n\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\u002F1.73 m2 (according to the Chronic Kidney Disease Epidemiology Collaboration) abbreviated formula CKD-EPI formula.\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug . A negative serum or urine pregnancy test before starting trial treatment is required for all women of childbearing potential.\n* Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last administration of investigational drug.\n* Patients give their consent to participate in TR projects and providing the mandatory samples.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Prior treatment with gemcitabine in combination with immunotherapies.\n* Tumor progression within the first 8 weeks from start of first-line treatment.\n* Activating EGFR or ALK mutations.\n* Concomitant use of other anti-cancer drugs or radiotherapy.\n* Major surgery within 1 month prior to treatment start.\n* Known history of any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.\n* Known history of tuberculosis, primary immunodeficiency, allogeneic tissue\u002Fsolid organ transplant, or receipt of live attenuated vaccine.\n* History of interstitial lung disease or severe pneumonitis.\n* Concomitant use of corticosteroids as premedication for gemcitabine therapy.\n* Concomitant or prior use of immunosuppressive medication such as interferon or methotrexate within 28 days prior to trial treatment start, with the exceptions of local (i.e., intranasal, inhaled and topical) corticosteroids.\n* Major blood vessel tumor invasion.\n* Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.\n* Unstable angina, myocardial infarction, congestive heart failure (NYHA classification Grade ≥2;27) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.\n* History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment initiation.\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.\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 study treatment initiation.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or to the Investigator's Brochure (IB).\n* Known or suspected hypersensitivity to gemcitabine or ivonescimab or to any component of the trial drugs.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to registration, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\nNote: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n\n* Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed).\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to registration is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time is within therapeutic limits according to the medical standard of the enrolling institution.\n\n  * Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic pressure ≥ 100 mmHg after oral antihypertensive therapy.\n  * Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to registration, however the following will be allowed:\n* Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n\n  * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by NCI CTCAE v5.0.\n  * Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.\n\nNote: Patients managed with indwelling catheters (e.g., PleurX) are allowed.\n\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":161,"type":20},47,[23],"This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1\u002FVEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.",[165,166],"NSCLC","NSCLC (Advanced Non-small Cell Lung Cancer)",[168,169,170,171,172,173],"advanced NSCLC","immune checkpoint inhibitors","Resistance to immunotherapy","Gemcitabine and Ivonescimab","Gemcitabine","Ivonescimab","2026-04-20",{"date":176,"type":36},"2026-04-21",{"date":178,"type":20},"2026-07",{"date":180,"type":20},"2029-07-31",{"name":42,"class":43},7,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":53,"minAge":190,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":211,"locationsCount":212},"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","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","70 Years",{"count":192,"type":20},156,[23],"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.",[196],"Metastatic NSCLC - Non-Small Cell Lung Cancer",[198,199,200,201,202,203,204,205],"Reduced-dose chemotherapy","Cemiplimab","carboplatin","metastatic NSCLC","PD-L1 \u003C50%","Non-Small Cell Lung Cancer","older and frail patients","phase II","2026-04-10",{"date":208,"type":36},"2026-04-15",{"date":206,"type":36},{"date":40,"type":20},{"name":42,"class":43},17,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100621038","phase-2-terbinafine-for-biochemically-recurrent-prostate-cancer-terbinapro-100621038","NCT07365423","Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)","Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study","TerbinaPro","Key Inclusion Criteria:\n\n* Patients after definitive treatment for localized prostate cancer and exhaustion of standard curative options (i.e. after prostatectomy and adjuvant \u002Fsalvage radiotherapy; definite radiotherapy, brachytherapy; additional previous Stereotactic Body Radiation Therapy (SBRT) to treat visible oligometastatic disease also allowed as long as confirmed Prostate-specific antigen (PSA) progression is present after SBRT)\n* Non-castrate levels of testosterone (≥ 5 nmol\u002Fl; previous androgen deprivation therapy (ADT) allowed as long as testosterone levels have recovered before study entry)\n* No evidence of distant metastatic disease on conventional imaging (Computed Tomography (CT) and bone scan) or Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) CT.\n* Patients with PSMA positive lymph nodes on PSMA PET CT can still be included if the short axis of the largest lymph node is \\\u003C 20 mm for lymph nodes below aortic bifurcation or \\\u003C 10 mm above the aortic bifurcation.\n* PSA of ≥1 ng\u002Fml after radical prostatectomy or ≥2 ng\u002Fml above the nadir (with recovered testosterone) after primary radiotherapy; confirmation of rising PSA in at least a second measurement at least 2 weeks apart\n* Patient declining start of ADT and \u002For an androgen receptor pathway inhibitor (ARPI) and\u002For judged as not in need of immediate ADT\u002FARPI start by treating physician\n\nKey Exclusion Criteria:\n\n* Pre-existing known chronic or acute liver disease\n* Known history of systemic lupus erythematosus or any form of lupus (including cutaneous, drug-induced, or lupus nephritis)\n* Pure neuroendocrine\u002Fsmall-cell histologic variant of prostate cancer",{"count":222,"type":20},42,[23],"TerbinaPro is a phase II drug-repurposing study evaluating oral Terbinafine in patients with biochemical recurrence of prostate cancer after prior local treatment with curative intent. When local salvage strategies have been exhausted, recurrence usually reflects micro-metastatic disease without clearly visible metastases on imaging. Standard therapy with androgen deprivation or androgen-receptor pathway inhibitors can effectively control disease but is associated with substantial side effects and negative impact on quality of life. Terbinafine is a long-licensed, generic antifungal drug that inhibits squalene epoxidase (SQLE), an enzyme that may play a role in prostate cancer progression. Preclinical and limited clinical data suggest potential anti-cancer activity.",[226],"Recurrent Prostate Cancer",[228,229,205,230],"recurrent prostate cancer","Terbinafine","drug-repurposing Study","2026-03-27",{"date":233,"type":36},"2026-04-02",{"date":235,"type":20},"2026-05",{"date":237,"type":20},"2030-10",{"name":42,"class":43},11,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":254,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":115},"100543646","phase-2-intratumoral-int230-6-followed-by-neoadjuvant-immuno-chemotherapy-in-patients-with-early-tnbc-invincible-4-sakk-100543646","NCT06358573","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK","Inclusion Criteria:\n\n* Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.\n* Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) \u002F College of American Pathologist (CAP) guidelines .\n* The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.\n* Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus.\n* Measurable disease in the breast with at least one lesion with a diameter ≥ 1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable.\n* Male or female subject Age ≥ 18 years.\n* ECOG performance status 0-1\n* Adequate bone marrow function (administration of G-CSF, EPO and\u002For blood transfusion within 14 days before registration is not allowed):\n\n  * neutrophil count ≥ 1.5 x 109\u002FL\n  * platelet count ≥ 100 x 109\u002FL\n  * hemoglobin ≥ 90 g\u002FL\n* Adequate hepatic function:\n\n  * total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 x ULN\n  * AST and ALT ≤ 2.5 x ULN,\n  * Albumin 30 ≥ g\u002FL\n  * Lactate Dehydrogenase (LDH) \\\u003C2.5 ULN\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 ml\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula)\n* Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiography (ECHO)\n* Adequate coagulation function:\n\n  * INR ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * If the patient is receiving anticoagulant therapy, the treating physician must determine that the anticoagulation can be stopped at least 24 hours prior to injection.\n* Women of childbearing potential must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 7 months after the last dose of INT230-6 or 6 months after standard of care treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. (www.swissmedicinfo.ch).\n* Men agree not to donate sperm or to father a child by using effective contraception during trial treatment and until 6 months after the last dose of INT230-6 or standard of care treatment (www.swissmedicinfo.ch).\n\nExclusion Criteria:\n\n* Inflammatory Breast Cancer cT4d\n* Unfavorable relation between tumor size and breast size as determined by judgement of the treating physician, surgeon and\u002For investigator, where tumor shrinkage during neoadjuvant immunochemotherapy is required for breast conserving surgery to be considered.\n* Unfavorable tumor location that can potentially result in an unfavorable cosmetic outcome (e.g. high upper inner quadrant) and\u002For close skin contact by judgment of the treating physician, surgeon and\u002For investigator.\n* The following histological subtypes of TNBC are excluded: Classic adenoid cystic carcinoma, secretory carcinoma, low-grade adenosquamous carcinoma, tall cell carcinoma with reversed polarity, high-grade metaplastic\n* History of invasive malignancy ≤3 years prior to signing informed consent (except treated basal cell or squamous cell skin cancer or in situ cervical cancer)\n* Prior chemotherapy, targeted therapy, radiation therapy or anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.\n* Concurrent bilateral breast cancer\n* Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial.\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA II or IV; unstable angina pectoris, history of myocardial infarction and acute coronary syndrome requiring stenting\u002Fbypass surgery within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Known history of human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.\n* Active autoimmune disease that required systemic treatment in past 2 years (e.g., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroid hormone replacement, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Known history of tuberculosis.\n* Known history of allogeneic organ or stem cell transplant.\n* Receipt of live attenuated vaccine (including yellow fever vaccine) within 30 days prior to registration.\n* Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration, with the exceptions of local (intranasal, topical and inhaled) corticosteroids, or systemic corticosteroids which must not exceed 10 mg\u002Fday of prednisone or a dose equivalent corticosteroid, and the premedication for chemotherapy.\n* Concomitant anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban), direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors\u002Fantiplatelet agents that cannot be stopped 24 hours before the administration of INT230-6. Aspirin (up to 300 mg\u002Fday) is allowed.\n* Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB) and the immuno-chemotherapy treatment according to the approved product information.\n* Known hypersensitivity to trial drug or to any component of the trial drug or immuno-chemotherapy treatment.\n* Incapacitated adults and any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":248,"type":20},61,[23],"About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66\u002F22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.",[252,253],"Triple-negative Breast Cancer","TNBC - Triple-Negative Breast Cancer",[255,256,257,258,259,260],"triple-negative breast cancer","TNBC","Intratumoral INT230-6","neoadjuvant immuno-chemotherapy","INT230-6","early stage",{"date":233,"type":36},{"date":263,"type":36},"2024-10-24",{"date":265,"type":20},"2031-12",{"name":42,"class":43},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":182},"100524851","trial-comparing-systemic-therapy-alone-and-with-local-ablative-treatment-for-stage-iv-nscl-cancer-patients-100524851","NCT06114108","Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients","Phase III Randomized Controlled Trial Comparing Maintenance Systemic Therapy Alone With Systemic Therapy Plus Local Ablative Treatment for Patients With Advanced Stage IV Non-small Cell Lung Cancer","salVage","Inclusion Criteria:\n\nPatients fulfilling all of the following inclusion criteria at screening may be enrolled in the trial.\n\n* The inclusion criteria are irrespective from the tumor burden at the time of primary diagnosis before initiation of first line systemic therapy. Treatment of brain metastases upfront or after an induction phase of standard systemic therapy is done according to the standard practice of the treating center.\n* Adults (18 years or older)\n* Tissue confirmed, pre-treatment clinical stage IV NSCLC\n* ECOG performance status ≤ 1\n* Patients responding after 3 cycles (4th bridging cycle up until randomization is allowed) or 3 months of first line SoC systemic therapy with PR or SD in restaging imaging, and presenting with (induced) oligometastatic or oligopersistent NSCLC defined as a maximum of 5 residual extracranial, distant metastases\n* Patients may have up to 5 cranial metastases in addition to the oligoresidual extracranial metastases as long as they are amenable for radiotherapy or surgery.\n* The primary tumor and all oligopersistent metastases must be amenable for radical LAT (surgery or radiotherapy)\n* Patients of reproductive age agree to use double contraception during the study\n* Patient is able to understand trial procedures and is able\u002Fwilling to adhere to trial procedures as confirmed by signature\n\nExclusion Criteria:\n\nThe presence of any one of the following exclusion criteria at screening will lead to exclusion of the participant:\n\n* Serious concomitant disorder that would compromise patient safety during LAT\n* Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2\n* Metastatic locations such as malignant ascites, malignant pleural or malignant pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses\u002Fabdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques, leptomeningeal carcinomatosis\n* Women who are pregnant or breast feeding\n* Patient is currently involved in a trial that either does not permit participation in other trials or would result in excessive patient burden if another trial were joined. In such cases, the co-investigators' team and the Patient Advisory Board will decide on participation on an individual basis.",{"count":276,"type":20},128,[278],"NA","Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and\u002For radiation.",[281,282],"Non-small Cell Lung Cancer (NSCLC)","Stage IV",[284,285,286],"Non-small cell lung cancer (NSCLC)","Local consolidative treatment (LAT)","patient-reported outcome measures (PROMs)",{"date":233,"type":36},{"date":289,"type":36},"2023-12-21",{"date":291,"type":20},"2028-03-01",{"name":42,"class":43},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":319,"locationsCount":239},"100604448","phase-2-magnesium-supplementation-in-advanced-non-small-cell-lung-cancer-nsclc-100604448","NCT07149649","Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)","Magnesium Supplementation in Addition to Standard Chemo-immunotherapy in Patients With Locally Advanced Unresectable Stage III or Metastatic Stage IV Non-small Cell Lung Cancer (NSCLC). A Double-blind Randomized Multicenter Phase II\u002FIII Study.","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures;\n* Histologically or cytologically confirmed diagnosis of NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified);\n* Patients planned for systemic first-line therapy with a combination of a carboplatin-based doublet chemotherapy and a PD-1 \u002F PD-L1 targeting immune checkpoint inhibitor;\n* Patients not eligible for immune checkpoint inhibitor monotherapy irrespective of PD-L1 expression;\n* Locally advanced unresectable stage III or metastatic stage IV disease (defined as TNM, according to 8th edition) not eligible for curative surgery and\u002For definitive (curative intended) chemoradiotherapy;\n* No sensitizing EGFR mutation, METex14 skipping mutation, BRAF V600E mutation, ALK\u002FROS1\u002FRET, NTRK1\u002F2 gene rearrangements, HER2 mutations, amplifications detected in primary tumor or metastases;\n* Have not received prior systemic treatment for their metastatic NSCLC. Patients who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for nonmetastatic disease are eligible if the therapy was completed at least 12 months prior to the diagnosis of metastatic disease;\n* Patients with treated and stable CNS metastases are eligible, provided they meet the following criteria:\n\n  * No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed\n  * No stereotactic radiation or whole-brain radiation within 14 days prior to registration.\n* Patients with known HIV-infection, who are at low risk of AIDS-related outcomes, are eligible, provided they meet the following criteria:\n\n  * CD4+ T-cell counts are ≥ 350 cells\u002FųL\n  * No history of AIDS-defining opportunistic infection within past 12 months\n  * Patients have been on antiretroviral therapy (ART) for \\> 4 weeks before registration and have a HIV viral load \\\u003C 400 copies\u002FmL;\n* Patients with a prior malignancy and treated with curative intention are eligible if the 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;\n* Measurable disease per RECIST v1.134);\n* Age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* Adequate bone marrow function as per local guidelines;\n* Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of NSCLC;\n* Adequate renal function defined by stable estimated glomerular filtration rate (eGFR) ≥ 45 mL\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula);\n* Women of childbearing potential must use highly effective contraception (see chapter 9.4), are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.\n* Men agree not to donate sperm or to father a child during trial treatment and until 6 months after the last dose of investigational drug.\n\nExclusion Criteria:\n\n* Plasma magnesium concentration \\\u003C 0.4 mmol\u002Fl or \\> 1.2 mmol\u002FL\n* Treatment with any anti-cancer therapy within 21 days prior to registration (excluding hormonal therapy or anti-cancer surgery). Any previous anti-cancer therapy must have been administered with curative intent;\n* Treatment with radiotherapy within 14 days prior to registration (except for local pain control);\n* Patients planned for cisplatin-based chemo-immunotherapy;\n* Treatment with any other experimental drug within 28 days of registration;\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia);\n* Atrioventricular (AV) block of any degree unless being treated with cardiac pacemakers;\n* Bradycardia \\\u003C40\u002Fmin at steady state;\n* Active chronic Hepatitis C or Hepatitis B infection or any uncontrolled active systemic infection, needing antibiotic treatment within 14 days before registration;\n* Known history of tuberculosis, known history of relevant primary immunodeficiency, known history of allogeneic organ transplant, receipt of live attenuated vaccine within 28 days prior to registration;\n* Diagnosis of myasthenia gravis;\n* Concomitant or prior use of immunosuppressive medication within 28 days before registration, with the exceptions of:\n\n  * intranasal and inhaled corticosteroids\n  * systemic corticosteroids ≤ 10 mg\u002Fday of prednisone, or a dose equivalent corticosteroid,\n  * premedication for chemotherapy;\n* Prior treatment with peroral or intravenous magnesium 14 days prior to registration;\n* Patient not willing to stop the use of peroral magnesium treatment including over the counter or lifestyle products;\n* Any concomitant drugs contraindicated for use with the trial drug according to the approved product information;\n* Known hypersensitivity to any of the trial drugs;\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":301,"type":20},230,[23,303],"PHASE3","This study investigates whether adding magnesium to the standard chemo-immunotherapy for advanced non-small cell lung cancer (NSCLC) can improve treatment outcomes. Magnesium is important for immune function, and low levels during chemotherapy are common. Participants are randomly assigned to receive either magnesium or a placebo, both as infusions and tablets. Neither the participants nor the doctors know who receives which treatment. The study compares the two groups to see if magnesium helps and how well it is tolerated.",[196],[307,308,309,203,310,311,312,313],"Magnesium supplementation","Magnesium aspartate hydrochloride","Placebo","phase II\u002Fphase III","unresectable stage III NSCLC","metastatic stage IV NSCLC","double-blind randomized","2026-03-25",{"date":231,"type":36},{"date":178,"type":20},{"date":318,"type":20},"2035-03-31",{"name":42,"class":43},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":334,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":151},"100580265","phase-2-feasibility-of-total-neoadjuvant-treatment-with-hyperthermia-in-patients-with-high-risk-extremity-and-trunk-soft-tissue-sarcoma-tnt-hype-100580265","NCT06835049","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial","TNT-HYPE","Main Inclusion Criteria:\n\n* Histologically confirmed primary high-risk Soft tissue sarcoma (STS) of extremity or trunk.\n* High-risk according to the prognostic Sarculator tool: 10-year OS probability \\\u003C 60%5.\n* Resectable tumor: resectability is based on pre-operative imaging and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only a R2 resection is feasible.\n* Measurable disease per RECIST v1.1.\n* Diagnostic biopsy is available for the central pathology review.\n* Candidate for chemotherapy regimen according to protocol.\n* Candidate for loco-regional HT.\n* Adequate bone marrow function, hepatic function, renal function, cardiac function and coagulation function.\n\nMain Exclusion Criteria:\n\n* Metastatic disease.\n* Previous Whoops resection.\n* Ex-ulcerating tumors or tumors infiltrating the skin.\n* Other invasive malignancy within 5 years, with the exception of adequately treated non melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6 prostate cancer.\n* Any previous radiotherapy (RT) or systemic therapy for the present tumor.\n* Previous treatment with maximum cumulative doses (450 mg\u002Fm² doxorubicin or equivalent 900 mg\u002Fm² epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones.\n* Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.\n* Concomitant use of other anti-cancer drugs or RT.\n* No metal implants in the region of tumor or cardiac implant electronic devices (CIEDs).\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last 12 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Active and uncontrolled infections, in particular urinary tract infections.\n* Inflammation of the urinary bladder (interstitial cystitis).\n* History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration.\n* Vaccination with live vaccines within 30 days prior to registration.\n* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).",{"count":329,"type":20},24,[23],"Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.",[333],"Sarcoma,Soft Tissue",[335,326,205,336,337],"Sarcoma, soft-tissue","Neoadjuvant Treatment","hyperthermia","2025-12-23",{"date":340,"type":36},"2025-12-30",{"date":342,"type":36},"2025-10-27",{"date":344,"type":20},"2031-03-31",{"name":42,"class":43},{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":151},"100550847","phase-2-neodoxy-targeting-breast-cancer-stem-cells-with-doxycycline-100550847","NCT06452394","NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline","NEODOXy: Targeting Cancer Stem Cells With NEOadjuvant DOXYcycline in Patients With Early Estrogen Receptor Positive \u002F Human Epidermal Growth Factor Receptor 2- Negative Breast Cancer. A Prospective, Multicenter, Single Arm, Open Label Phase II Trial","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and current ICH GCP E6 regulations before registration and prior to any trial specific procedures.\n* Histologically confirmed ER+\u002FHER2- primary invasive breast cancer, according to ASCO\u002FCAP Guideline1,2, defined as ER expression rate ≥ 1%.\n* Patients are candidate for curative surgery and with a tumor size of at least 2 cm and nodal classification cN0-3 according to the 8th edition, January 2017 of the anatomic TNM classification3.\n* Patients with multiple synchronous ipsilateral tumors are allowed, as long as all lesions are ER+\u002FHER2-. Only one target lesion will be considered for ALDH1 primary endpoint, and the target lesion has to be the largest lesion.\n* Patients are planned for neoadjuvant chemotherapy according to the local standards.\n* Patients accept standard curative surgery after neoadjuvant chemotherapy with 4 cycles of epirubicin and cyclophosphamide (EC) followed by 12 doses of weekly paclitaxel (or nab-paclitaxel).\n* Diagnostic tumor tissue is available for the mandatory central pathology examinations; or an additional biopsy is planned in case of lack of remaining material from the diagnostic biopsy, provided that the patient has consented to the optional TR-project.\n* Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration in this trial and the patient has no evidence of disease at registration. Less than 2 years is acceptable for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.\n* Male or female patients age ≥ 18 years.\n* ECOG performance status 0-1.\n* Adequate bone marrow function:\n\n  * neutrophil count ≥ 1.5 x 10\\^9\u002FL,\n  * platelet count ≥ 100 x 10\\^9\u002FL,\n  * hemoglobin ≥ 90 g\u002FL.\n* Adequate hepatic function:\n\n  * total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease max. 3.0 x ULN),\n  * AST and ALT ≤ 2.5 x ULN.\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula).\n* No known cardiac dysfunction contraindicating the planned neoadjuvant chemotherapy with 4 cycles of EC followed by 12 doses of weekly paclitaxel.\n* Women of childbearing potential must use highly effective, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 12 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.\n* Men agree not to donate sperm or to father a child during trial treatment and until 12 months after the last dose of investigational drug.\n* Patient is able and willing to swallow trial drug as whole tablet.\n\nExclusion Criteria:\n\n* Patients with 2 synchronous breast cancers or more of different subtypes (other than ER+\u002FHER2-).\n* Metastatic patients.\n* Patients having received or planned to undergo neoadjuvant endocrine therapy or other investigational therapies before surgery.\n* History of intracranial hypertension (IH).\n* Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.\n* Concomitant use of drugs contraindicated with doxycycline according to the Swissmedic-approved product information or contraindicated according to the trial protocol.\n* Use of dietary supplements, natural therapies, phytotherapy or complementary and integrative medicines (homeopathy, spagyric remedies, etc) without approval of the sponsor.\n* Concomitant use of other anti-cancer drugs or radiotherapy.\n* Patients having received doxycycline or other antibiotics of the cyclin family within 28 days before registration.\n* Known hypersensitivity to cyclin group of substances, including tetracyclines, doxycycline or to any component of the trial drug.\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":354,"type":20},50,[23],"Despite modern surgical and medical treatments, breast cancer can re-occur and lead 20% of patients to death. During the last 20 years, pre-clinical studies have shown that treatment failures may be due to the presence of a sub-type of cancer cells, the cancer stem cells, which are resistant to chemotherapy and radiotherapy. By chance, doxycycline, an old, inexpensive and safe molecule seems to target effectively these cancer stem cells. This study proposes to check for the clinical efficacy of doxycycline to target the cancer stem cells and improve the response to neoadjuvant chemotherapy in ER+\u002FHER2- breast cancers.",[358],"Breast Cancer",[360,361,362,363,364,358],"early ER+\u002FHER2- breast cancer","NEODOXy","Doxycycline","Human Epidermal Growth Factor Receptor 2 negative","Estrogen Receptor",{"date":340,"type":36},{"date":367,"type":36},"2025-07-16",{"date":369,"type":20},"2028-12-31",{"name":42,"class":43},""]