[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leptomeningeal-metastasis-from-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leptomeningeal-metastasis-from-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100650888","ctdna-driven-adaptive-proton-craniospinal-irradiation-in-non-small-cell-lung-cancer-with-leptomeningeal-metastasis-after-resistance-to-third-generation-tkis-in-the-consolidation-phase-100650888",false,"NCT07751536","ctDNA-driven Adaptive Proton Craniospinal Irradiation in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis After Resistance to Third-Generation TKIs in the Consolidation Phase","Dynamic Adaptive Radiotherapy for Non-Small Cell Lung Cancer With Leptomeningeal Metastasis After Resistance to Third-Generation TKIs in the Consolidation Phase: A Multicenter Randomized Controlled Trial Comparing Outcomes Between Proton Craniospinal Irradiation and Intrathecal Pemetrexed (DART-LM)","Inclusion Criteria:\n\n1. Voluntary participation with written informed consent obtained prior to any study-specific procedures, and willingness and ability to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.\n2. Male or female patients aged between 18 and 75 years (inclusive) at the time of signing informed consent.\n3. Primary tumour confirmed as non-small cell lung cancer (NSCLC) by cytology or histology, harbouring EGFR-sensitive mutations (including 19del and exon 21 L858R). Testing reports for EGFR mutation status must be available; if no prior report exists, submission of archived tissue or baseline biopsy for assessment is mandatory.\n4. Leptomeningeal metastasis (LM) diagnosed according to the EANO-ESMO guidelines, based on cerebrospinal fluid (CSF) cytology and\u002For imaging evidence of leptomeningeal enhancement or ventriculomegaly.\n5. Disease progression of LM documented after treatment with third-generation EGFR-TKIs (including osimertinib, almonertinib, or furmonertinib). Patients may continue their current EGFR-TKI therapy during the study, provided that extracranial disease remains stable.\n6. The patient has had an Ommaya reservoir implanted or has undergone Ommaya reservoir placement prior to study entry, and is willing to undergo intrathecal injections via the reservoir throughout the study.\n7. Extracranial disease is stable, defined as no progressive extracranial lesions (per RECIST v1.1) within 28 days prior to enrollment. Continuation of background systemic EGFR-TKI therapy is permitted.\n8. Life expectancy ≥ 3 months as assessed by the investigator.\n9. Karnofsky Performance Status (KPS) ≥ 70 at screening.\n10. Medically fit to tolerate intrathecal pemetrexed and proton craniospinal irradiation (pCSI), as determined by the investigator.\n11. Adequate organ and bone marrow function as defined below (within 14 days prior to initiation of study treatment), without having received blood transfusions, granulocyte colony-stimulating factor (G-CSF), or hematopoietic growth factors within 14 days prior to screening:\n\n    * Hematology:\n\n      * Haemoglobin (Hb) ≥ 90 g\u002FL;\n      * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n      * Platelets (PLT) ≥ 75 × 10⁹\u002FL.\n    * Blood Chemistry:\n\n      * Total Bilirubin (TBIL) ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome);\n      * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5.0 × ULN;\n      * Serum Creatinine (Cr) ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula):\n      * Male: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine)\n      * Female: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine) × 0.85 (Note: Weight in kg; Serum creatinine in mg\u002FdL)\n    * Coagulation Function:\n\n      * International Normalized Ratio (INR) ≤ 2.0 or Prothrombin Time (PT) ≤ 6 seconds above the upper limit of normal.\n12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment. If the urine test cannot be definitively confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive.\n13. Female subjects of childbearing potential who are sexually active with unsterilised male partners must agree to use highly effective contraception starting at screening and continue for 180 days after the last dose of study treatment.\n14. Sexually active male subjects who have not undergone sterilisation and who are sexually active with female partners of childbearing potential must agree to use effective contraception starting at screening and continue for 180 days after the last dose of study treatment. Decisions regarding cessation of contraception beyond this timeframe should be discussed with the investigator.\n15. Subjects must be willing and able to comply with the study protocol, including scheduled visits, treatment administration, laboratory tests, imaging assessments, and CSF sample collections via the Ommaya reservoir.\n\nExclusion Criteria:\n\n* Patients with concurrent primary tumors of the brain or spinal cord.\n* Patients with severe central nervous system diseases (including severe cerebral herniation or coma).\n* Patients with life-threatening or uncontrolled systemic diseases, such as uncontrolled hypertension or active bleeding tendency.\n* Patients with other concurrent malignancies, except for basal cell carcinoma of the skin and carcinoma in situ.\n* Patients who have previously received whole-brain radiotherapy or photon radiotherapy to involved fields of the brain and spinal cord.\n* Patients judged by the investigator to be unsuitable for participation, or who have factors that may affect compliance with the protocol.\n* Toxicity from prior treatment has not recovered to normal or to grade 1 per NCI-CTCAE version 6.0.\n* Patients with drug allergy or metabolic disorders to the drugs used in this protocol.\n* Pregnant or lactating women, or female patients who plan to become pregnant during the study period or within 6 months after the last dose.\n* Patients who are concurrently participating in other clinical studies\n* Patients with pre-existing cardiac dysfunction.","ALL","18 Years","75 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"NA","\\*\\*Brief Summary (English)\\*\\*\n\nThe goal of this clinical trial is to learn if a risk-adaptive consolidation therapy, guided by cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) clearance kinetics after induction intrathecal pemetrexed, can improve intracranial progression-free survival (iPFS) compared to standard intrathecal pemetrexed consolidation in patients with leptomeningeal metastasis (LM) from EGFR-mutant non-small cell lung cancer (NSCLC) that has progressed on third-generation EGFR-TKIs. It will also learn about the safety and tolerability of proton craniospinal irradiation (pCSI) in this setting.\n\nThe main questions it aims to answer are:\n\n* Does risk-adaptive consolidation therapy (pCSI with or without concurrent low-dose intrathecal pemetrexed) prolong iPFS compared to standard intrathecal pemetrexed consolidation?\n* What medical problems do participants have when receiving pCSI or intrathecal pemetrexed?\n\nResearchers will compare the experimental arm (risk-adaptive consolidation: pCSI for intermediate-risk, or pCSI with concurrent low-dose intrathecal pemetrexed for high-risk patients) to the control arm (standard intrathecal pemetrexed consolidation) to see if the adaptive strategy improves survival outcomes.\n\nParticipants will:\n\n* Receive induction intrathecal pemetrexed (40 mg, biw, q3w for 2 cycles) via Ommaya reservoir.\n* Undergo CSF collection at baseline and after induction for ctDNA (maxVAF) analysis to determine risk stratification (low, intermediate, high).\n* If stratified as intermediate or high risk, be randomly assigned to either standard intrathecal pemetrexed consolidation or risk-adaptive consolidation (pCSI 30 GyE\u002F10f for intermediate-risk; pCSI 30 GyE\u002F10f with concurrent intrathecal pemetrexed 30 mg on d1, d8 for high-risk).\n* Receive maintenance intrathecal pemetrexed (40 mg, q4w) until intracranial progression.\n* Undergo regular efficacy assessments (contrast-enhanced MRI of brain and whole spine) every 8 weeks, and complete neurocognitive and quality-of-life questionnaires.",[27],"Leptomeningeal Metastasis From Lung Cancer",[29,30,31,32,33],"Leptomeningeal Metastasis from Lung Cancer","Non-Small Cell Lung Cancer","proton craniospinal irradiation","ctDNA","Third-generation TKIs","RECRUITING","2026-08-03",{"date":37,"type":38},"2026-08-07","ACTUAL",{"date":40,"type":21},"2026-08-05",{"date":42,"type":21},"2028-07-31",{"name":44,"class":45},"Shuanghu Yuan","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100650310","phase-1-amivantamab-combined-with-intrathecal-pemetrexed-for-lm-from-egfr-mutated-lung-adenocarcinoma-100650310","NCT07744529","Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma","A Single-Arm Phase II Exploratory Clinical Study of Amivantamab Combined With Intrathecal Pemetrexed for Leptomeningeal Metastasis From EGFR-Mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* Voluntary participation in the clinical study: fully understands and is informed of this study and signs the written informed consent form; is willing and able to complete all trial procedures.\n* Age: \\>=18 years; male or female.\n* Patients with EGFR-mutated lung adenocarcinoma with leptomeningeal metastasis diagnosed according to the EANO-ESMO guidelines.\n* Expected survival of at least 3 months.\n* Adequate organ and bone marrow function, with no severe hematopoietic abnormality and no severe cardiac, pulmonary, hepatic or renal dysfunction or immunodeficiency (within 14 days before use of study drug, no blood transfusion, granulocyte colony-stimulating factor or other relevant medical support):\n\n  1. Complete blood count: absolute neutrophil count (ANC) \\>=1.5 x 10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75 x 10\\^9\u002FL, hemoglobin \\>=9 g\u002FdL (if bone marrow is involved, platelets \\>=50 x 10\\^9\u002FL, ANC \\>=1.0 x 10\\^9\u002FL and hemoglobin \\>=8 g\u002FdL).\n  2. Liver function: serum bilirubin \\\u003C=1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=1.5 x ULN (if there is liver involvement, AST and ALT \\\u003C=5 x ULN are allowed).\n  3. Renal function: serum creatinine \\\u003C=1.5 x ULN.\n  4. Coagulation function: INR \\\u003C=1.5 x ULN; PT and APTT \\\u003C=1.5 x ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant treatment at screening).\n* Left ventricular ejection fraction (LVEF) in cardiac function examination \\>=50%.\n* Negative serum pregnancy test, and effective contraception from signing the informed consent form until 6 months after the last chemotherapy dose.\n* Thyroid-stimulating hormone (TSH), free thyroxine (FT4) or free triiodothyronine (FT3) within +\u002F-10% of the normal range.\n* Ophthalmic examination, including dilated fundus examination, slit-lamp examination and color fundus photography.\n\nExclusion Criteria:\n\n* Currently participating in another clinical study, or less than 4 weeks between the first dose of the study drug and the end of treatment in a previous clinical study.\n* History of other malignancies within the past 5 years.\n* Patients who have received CNS-directed prophylactic treatment.\n* Patients with known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome.\n* Patients with active autoimmune disease or a history of autoimmune disease with a high risk of recurrence, including but not limited to immune-related neuropathy, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel cancer (including Crohn disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome.\n* Patients with active chronic hepatitis B or active hepatitis C. Patients who are positive for hepatitis B surface antigen or hepatitis C virus antibody during screening may be enrolled only after further HBV DNA titer testing (not higher than 1000 IU\u002FmL) and HCV RNA testing (not exceeding the lower limit of detection of the assay), and after active hepatitis B or hepatitis C infection requiring treatment has been excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment and patients with cured hepatitis C may be enrolled.\n* Active pulmonary tuberculosis.\n* Current interstitial lung disease or infectious pneumonia.\n* Active infection requiring systemic anti-infective therapy, including but not limited to bacterial, fungal or viral infection.\n* Within 6 months before screening, New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmia, or electrocardiographic evidence of acute ischemia or myocardial infarction.\n* QTcF interval \\>480 msec, unless secondary to bundle branch block.\n* Uncontrolled comorbid disease, including but not limited to uncontrolled hypertension, active peptic ulcer or bleeding disorder.\n* History of psychiatric illness; incapacity or limited capacity for civil conduct.\n* In the judgment of the investigator, the patient's underlying condition may increase the risk of receiving study drug treatment or confound the occurrence and assessment of toxic reactions.\n* Other patients whom the investigator considers unsuitable for participation in this study.",{"count":54,"type":21},15,[56,57],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid.\n\nThe main questions this study aims to answer are:\n\nWhat medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?\n\nParticipants will:\n\nReceive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.\n\nContinue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.\n\nHave cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.\n\nHave tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.\n\nHave imaging tests, including enhanced MRI, about every 3 months to check the disease.\n\nBe followed by clinic visits and\u002For telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.",[27],"2026-08-01",{"date":62,"type":38},"2026-08-04",{"date":64,"type":38},"2026-05-28",{"date":66,"type":21},"2028-05-28",{"name":68,"class":45},"Second Affiliated Hospital, Zhejiang University, School of Medicine",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":69},"100635931","phase-1-exploration-of-the-application-of-methotrexate-loaded-drug-vesicles-in-intrathecal-injection-for-meningeal-metastasis-of-lung-cancer-100635931","NCT07559097","Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer","A Phase I\u002FII, Single-arm, Single-center Clinical Study: Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer","Inclusion Criteria:\n\n\\-\n\nParticipants can be enrolled in this study only if they meet all of the following inclusion criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosed with lung cancer by pathological biopsy or cytology;\n3. Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;\n4. Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;\n5. ECOG PS 0 - 3.\n\nExclusion Criteria:\n\n\\-\n\nThe following conditions will disqualify a patient from participating in this study:\n\n1. Concurrent central nervous system infectious diseases;\n2. ECOG PS ≥ 4;\n3. Patients currently participating in other interventional studies;\n4. History of or current severe immunodeficiency diseases;\n5. Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.",{"count":78,"type":21},14,[56,57],"This is a phase I\u002FII, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care.\n\nThe study consists of two phases: Phase I employs an accelerated titration combined with a \"3+3\" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Phase II further assesses the objective response rate (ORR) at the RP2D. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile.\n\nApproximately 10-20 patients with cytologically confirmed leptomeningeal metastasis (age ≥18 years, ECOG PS 0-3) will be enrolled. Participants will receive intrathecal MTX-MPs on days 1, 3, and 5 of the first cycle, followed by once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or death.\n\nTumor response will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for leptomeningeal metastasis, and adverse events will be graded according to CTCAE version 5.0. This exploratory study may provide a novel local therapeutic approach for leptomeningeal metastasis from lung cancer.",[27],"2026-04-24",{"date":84,"type":38},"2026-04-30",{"date":86,"type":38},"2025-09-08",{"date":88,"type":21},"2027-12-31",{"name":90,"class":91},"Henan Cancer Hospital","OTHER_GOV"]