[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epidermal-growth-factor-receptor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epidermal-growth-factor-receptor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,83,114],{"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":41,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495",false,"NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancer","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","NSCLC (Non-small Cell Lung Cancer)","HNSCC","EGFR",[36,39,28,40,31,42],"NSCLC","RECRUITING","2026-06-08",{"date":46,"type":47},"2026-06-10","ACTUAL",{"date":49,"type":47},"2026-03-31",{"date":51,"type":20},"2029-07",{"name":53,"class":54},"EpiBiologics","INDUSTRY",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100501159","phase-2-intrathecal-pemetrexed-for-leptomeningeal-metastasis-in-egfr-mutant-nsclc-100501159","NCT05805631","Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC","Efficacy of Intrathecal Pemetrexed Combined With Tyrosine Kinase Inhibitor for Treating Leptomeningeal Metastasis in EGFR-Mutant NSCLC After Failure of Osimertinib","Inclusion criteria\n\n* At least 20 years of age.\n* Patients with metastatic non-squamous NSCLC harboring known EGFR activating mutation and with a diagnosis of probable or confirmed LM by the European Association of Neuro-Oncology-European Society for Medical Oncology (EANO-ESMO) guideline. \\[5\\] EGFR activating mutations include exon19 deletion, T790M, L858R, G719X, L861Q, or S768I.\n* Intracranial disease progression after osimertinib use, proved by contrast-enhanced MRI\n* Stable extra-cranial disease status, judged by investigators.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-3 and a minimum life expectancy of 12 weeks\n* Normal bone marrow and organ function as defined below:\n\n  * Marrow: Hemoglobin ≥9gm\u002FdL, ANC ≥1500\u002Fmm3 platelets ≥100,000\u002Fmm3\n  * Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ≤3 x ULN.\n  * Renal: Creatinine clearance (Ccr) ≥45 mL\u002Fmin.\n* For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception that results in a low failure rate (\\\u003C 1% per year) when used consistently and correctly, and to continue its use for 5 months after the last dose of IP. Such methods include: combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n* Willing to provide CSF and plasma samples for ctDNA analysis.\n\nExclusion criteria\n\n* Uncontrolled extra-CNS disease which needs other systemic treatment than EGFR-TKI.\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia (\\> 1.5 mmol\u002FL ionized calcium or Ca \\> 12 mg\u002FdL or corrected serum calcium \\> ULN). Patients who are receiving denosumab prior to study enrollment must be willing and eligible to receive a bisphosphonate instead while in the study.\n* Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS \\> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\n* On chronic systemic steroid therapy more than 20 mg prednisolone per day (or equivalent) or on any other form of immunosuppressive medication\n* Has received a live-virus vaccination within 30 days of planned treatment start\n* Systemic cytotoxic chemotherapy or major surgery within 2 weeks of the first dose of study medication\n* Active infection requiring therapy\n* History of Human Immunodeficiency Virus (HIV) infection.\n* Hepatitis B carrier: Patients with HBV infection were required to be receiving effective antiviral therapy and have a viral load less than 100 IU\u002FmL at screening\n* Active Hepatitis C\n* Has received intrathecal chemotherapy within 2 weeks before the start of IP\n* Has received whole-brain radiotherapy (WBRT) within 2 weeks before the start of IP\n* Uncontrolled epilepsy\n* History of allergic reaction to intravenous pemetrexed.\n* Severe coagulation abnormality (INR \\> 2).\n* Severe symptomatic hydrocephalus that requires other treatment modalities other than IP\n* Bulky intra-cranial lesion that requires other treatment modalities other than IP","20 Years",{"count":65,"type":20},23,[67],"PHASE2","Leptomeningeal metastasis (LM) is a complication of advanced non-small cell lung cancer (NSCLC). The incidence of LM in NSCLC patients is around 3-5 %, reaching 9.4 % of those with an epidermal growth factor receptor (EGFR) mutation. Generally, the efficacy of systemic treatment for LM is limited due to the blood-brain barrier. Osimertinib has a high central nervous system penetration rate, making it the preferred first-line treatment for EGFR-mutant NSCLC. Previous studies indicated that osimertinib had shown promising efficacy in pretreated patients harboring EGFR mutations and LM. However, intracranial disease progression eventually develops, and the prognosis of patients with LM progression after osimertinib is poor. Recently, intrathecal chemotherapy with pemetrexed (IP) was reported to be an alternative treatment in patients with NSCLC and LM. The results from a phase I\u002FII trial examining the efficacy and safety of IP in patients with EGFR-mutant NSCLC after the failure of previous TKI, and 83% of study enrollees received osimertinib before IP. The clinical response rate was 84.6%, and the median overall survival was 9.0 months. Despite initial promising efficacy, further trials are needed to verify these results. Therefore, the investigators plan to conduct a prospective study to examine the safety and effectiveness of IP combined with EGFR-TKI for patients with EGFR mutant NSCLC after osimertinib failure.",[70,27,71],"Carcinoma, Non-Small-Cell Lung","Leptomeningeal Metastasis","2026-03-23",{"date":74,"type":47},"2026-03-24",{"date":76,"type":47},"2024-08-01",{"date":78,"type":20},"2027-12-31",{"name":80,"class":81},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":82},"100598582","phase-2-bolstering-outcomes-after-induction-with-osimertinib-plus-chemotherapy-through-optimized-site-directed-primary-tumor-therapy-boost-trial-100598582","NCT07073365","Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)","A Prospective Cohort Observational Study of Local Therapy for the Primary Tumor in EGFR-Mutant Advanced Non-Small Cell Lung Cancer Following Osimertinib Plus Chemotherapy (FLAURA2 Regimen)","BOOST","\\\u003CInclusion Criteria\\>\n\nParticipants must meet all of the following criteria to be eligible:\n\n1. Age ≥ 20 years at the time of consent.\n2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).\n3. Presence of activating EGFR mutation (exon 19 deletion or L858R).\n4. Stage IV (metastatic) NSCLC at initial diagnosis.\n5. Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).\n6. Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.\n7. Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Adequate organ function based on institutional laboratory criteria.\n10. Ability to understand and willingness to provide written informed consent.\n\n\\\u003CExclusion Criteria\\>\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.\n2. Extensive, unresectable metastatic disease not amenable to local therapy.\n3. Untreated or clinically unstable brain metastases.\n4. Known contraindications to surgery or radiotherapy.\n5. Active second malignancy requiring concurrent treatment.\n6. Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.\n7. Pregnancy or breastfeeding at the time of enrollment.",{"count":92,"type":20},70,[67],"This is a single-arm, open-label, phase II study evaluating the clinical outcomes of local therapy (surgery or radiotherapy) to the primary tumor in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have achieved disease control following first-line treatment with the FLAURA2 regimen (osimertinib plus platinum-based chemotherapy). The primary objective is to assess the median progression-free survival (PFS) after local therapy.",[96,27],"Non-Small Cell Lung Cancer",[96,98,99,100,101,102,103],"EGFR Mutation","FLAURA2","Osimertinib","Local Therapy","Surgery","Radiotherapy","2025-12-22",{"date":106,"type":47},"2025-12-30",{"date":108,"type":47},"2025-07-01",{"date":110,"type":20},"2031-06-30",{"name":112,"class":113},"Pusan National University Hospital","OTHER",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":82},"100520678","phase-1-biologic-association-between-metabolic-magnetic-resonance-positron-emission-tomograph-mr-pet-and-tissue-measures-of-glycolysis-in-brain-tumors-of-infiltrating-glioblastoma-cells-100520678","NCT06059690","Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells","Biologic Association Between Metabolic MR-PET and Tissue Measures of Glycolysis in Brain Tumors Visualization, Quantitation, and Targeting of Infiltrating Glioblastoma Cells With pH Sensitive Amine Chemical Exchange Saturation Transfer Magnetic Resonance Imaging-KL2TR001882","Inclusion Criteria:\n\n* Age \\> 18\n* Patients with newly diagnosed or recurrent glioblastoma clinically indicated for resective surgery\n\nExclusion Criteria:\n\n* Patients who cannot obtain an MRI or FDG PET scan with contrast\n* Those with ferromagnetic implanted devices that might produce a safety hazard (e.g. infusion pumps, pace makers, aneurysm clips, etc.) will be excluded from the study along with subjects with severe claustrophobia or who have severely compromised renal function (GFR \\\u003C 30).",{"count":122,"type":20},50,[23,67],"The purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.",[126,127,27],"Glioblastoma Multiforme","Glycolytic Index","2025-10-06",{"date":130,"type":47},"2025-10-08",{"date":132,"type":47},"2023-09-06",{"date":134,"type":20},"2028-09-30",{"name":136,"class":113},"Jonsson Comprehensive Cancer Center"]