[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NovoCure GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100532707","phase-3-lunar-2-ttfields-with-pembrolizumab--platinum-based-chemotherapy-for-metastatic-nsclc-100532707",false,"NCT06216301","LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC","LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer","LUNAR-2","Inclusion Criteria\n\n* ≥22 years of age in the USA\n\n  ≥18 years of age outside of the USA.\n* Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \\[AJCC\\] criteria) non-squamous or squamous NSCLC.\n* Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.\n* Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease.\n* ECOG Performance Status (PS) of 0-1.\n* Adequate hematologic and end-organ function\n\n  o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding\n* If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception\n* All subjects must sign written informed consent.\n\nExclusion Criteria:\n\nAll individuals meeting any of the following exclusion criteria will be excluded from study participation:\n\n* Mixed small cell and NSCLC histology.\n* EGFR sensitizing mutation and\u002For ALK translocation, and\u002For ROS1 and\u002For RET targetable gene rearrangement, and\u002For METex14 skipping mutation, and\u002For NTRK1\u002F2 gene fusion and\u002For BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available.\n* Has received systemic therapy for metastatic disease.\n* Had major surgery \\\u003C3 weeks prior to randomization\n* Received radiation therapy to the lung that is \\> 30 Gy within 6 months of randomization.\n* Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Is expected to require any other form of antineoplastic therapy while on study.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has symptomatic Central Nervous System (CNS) metastases and\u002For carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 days prior to randomization.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.\n* Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization.\n* Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization.\n* Concurrent treatment with other experimental treatments for NSCLC while in the study.\n* Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin\u002Fcarboplatin, pemetrexed\u002Fpaclitaxel\u002Fnab-paclitaxel) .\n* Pregnant or breastfeeding\n* Admitted to an institution by administrative or court order.","ALL","18 Years",{"count":20,"type":21},734,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.",[27],"Metastatic Non-small Cell Lung Cancer",[29,30],"NSCLC","Metastatic","RECRUITING","2026-06-24",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2024-07-31",{"date":39,"type":21},"2028-10",{"name":41,"class":42},"NovoCure GmbH","INDUSTRY",98,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100558856","phase-3-ef-41keynote-d58-phase-3-study-of-optune-concomitant-with-temozolomide-plus-pembrolizumab-in-newly-diagnosed-glioblastoma-100558856","NCT06556563","EF-41\u002FKEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41\u002FKEYNOTE D58).","EF-41","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative) has provided documented informed consent for the study.\n2. Be ≥ 18 years of age on day of providing informed consent.\n3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.\n4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is not allowed.\n5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.\n6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg\u002Fm\\^2 daily x 5, Q28 days).\n7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization.\n8. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.\n\nExclusion Criteria:\n\n1. Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137).\n2. Ongoing requirement for \\>2 mg dexamethasone (or equivalent), due to intracranial mass effect.\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n4. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first study treatment.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n7. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n8. Early progressive disease after the end of TMZ\u002FRT. If pseudo progression is suspected, additional imaging studies should be performed to rule out true progression.\n9. Infratentorial or leptomeningeal disease.",{"count":53,"type":21},741,[24],"This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).",[57],"Glioblastoma",[59,60,57,61,62,63,64],"TTFields","Pembrolizumab","Tumor Treating Fields","Immunotherapy","Merck Sharp & Dohme LLC","GBM","2026-04-27",{"date":67,"type":35},"2026-05-01",{"date":69,"type":35},"2025-02-03",{"date":71,"type":21},"2029-04",{"name":41,"class":42},93,""]