19 recruiting, 10 active not recruiting, 10 completed, 10 unknown. 28 Phase 2, 16 Phase 1, 13 Not applicable, 5 Phase 4.
Follow Leptomeningeal Metastasis: new trials by email Literature Review of Leptomeningeal Metastasis trials Research Report on Leptomeningeal Metastasis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis Calibration Phase, Stepped Wedge Intervention Phase - Leptomeningeal Metastasis | Not applicable | Not yet recruiting | Case Comprehensive Cancer Center | 48 | 2026-11-01 | 2026-09-03 |
| BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI) - Leptomeningeal Metastasis, Breast Cancer | Phase 2 | Not yet recruiting | University of Miami | 40 | 2026-10-01 | 2026-09-01 |
| Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI. Thiotepa - Leptomeningeal Metastasis | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 50 | 2026-09-01 | 2026-08-21 |
| Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy SV-BR-1-GM Vaccine, Cyclophosphamide, Pembrolizumab - Brain Metastases, Leptomeningeal Metastasis | Phase 1 | Withdrawn | Medical College of Wisconsin | 2026-06-15 | 2026-06-17 | |
| Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI Zorifertinib Plus Intra-Ommaya CSF Chemotherapy - NSCLC (Non-small Cell Lung Carcinoma), Leptomeningeal Metastasis | Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 38 | 2026-05-30 | 2026-04-24 |
| Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis Furmonertinib 320mg qod po, Furmonertinib 160mg qd po - NSCLC (Advanced Non-small Cell Lung Cancer), Leptomeningeal Metastasis | Not applicable | Recruiting | Guangzhou University of Traditional Chinese Medicine | 42 | 2026-03-01 | 2026-04-02 |
| Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients - Leptomeningeal Metastasis, Lung Neoplasms, Non-Small Cell Lung Cancer | Not applicable | Recruiting | Second Affiliated Hospital of Nanchang University | 30 | 2026-02-15 | 2026-04-23 |
| A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases SHR-A1811, radiotherapy - Breast Cancer, Brain Metastases | Phase 1 / Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | 51 | 2025-09-30 | 2025-09-17 |
| Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. Pemetrexed - Leptomeningeal Metastasis | Phase 2 | Recruiting | Guangzhou Medical University | 36 | 2025-09-01 | 2026-01-30 |
| Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases 186RNL - Leptomeningeal Metastasis | Phase 1 / Phase 2 | Recruiting | Cerenome | 24 | 2025-07-02 | 2026-09-09 |
| AI-Based Ultrasound Prediction Model for Intracranial Pressure and Prognosis in Lung Cancer Patients With Leptomeningeal Metastasis: A Dual-Center Study Lung Cancer (NSCLC), Leptomeningeal Metastasis | Not yet recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 142 | 2025-07-01 | 2025-06-05 | |
| Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis Varian Eclipse - Leptomeningeal Metastasis | Not applicable | Active not recruiting | NYU Langone Health | 20 | 2025-05-14 | 2026-03-31 |
| Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases Firmonertinib, Intrathecal injection of pemetrexed - Leptomeningeal Metastasis, NSCLC | Phase 4 | Recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 40 | 2025-04-15 | 2025-07-29 |
| Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis AK112, Pemetrexed (Alimta) - Leptomeningeal Metastasis, Intrathecal Drug Delivery | Phase 1 / Phase 2 | Recruiting | Guangzhou Medical University | 34 | 2025-03-18 | 2025-05-20 |
| Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Pemetrexed (Alimta) - Leptomeningeal Metastasis, Pemetrexed | Phase 1 / Phase 2 | Active not recruiting | Guangzhou Medical University | 39 | 2025-03-17 | 2026-10-13 |
| Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis Cadonilimab (AK104), Pemetrexed (Alimta) - Leptomeningeal Metastasis | Phase 1 / Phase 2 | Active not recruiting | Guangzhou Medical University | 39 | 2025-03-07 | 2026-10-13 |
| A Study of the Safety and Efficacy of Pemetrexed Combined with Nivolumab Via Intraventricular Injection for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer with Leptomeningeal Metastases Intraventricular Pemetrexed, Intraventricular Nivolumab, Intraventricular Dexamethasone - Leptomeningeal Metastasis | Phase 2 | Recruiting | Shanghai Cancer Hospital, China | 97 | 2025-03-01 | 2025-03-30 |
| Concurrent Azeliragon With Craniospinal Irradiation Azeliragon, CSI - Solid Tumor, High-grade Glioma | Phase 1 | Active not recruiting | NYU Langone Health | 21 | 2025-02-18 | 2026-05-18 |
| Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis furmonertinib - Non-small Cell Lung Cancer, Leptomeningeal Metastasis | Not applicable | Recruiting | Henan Cancer Hospital | 60 | 2024-12-20 | 2025-03-06 |
| Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC Pemetrexed, Bevacizumab - Lung Cancer (NSCLC), Leptomeningeal Metastasis | Phase 1 | Recruiting | Shanghai Chest Hospital | 19 | 2024-12-09 | 2026-03-02 |
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Meningeal Carcinomatosis (62) · Carcinoma, Non-Small-Cell Lung (17) · Brain Neoplasms (10) · Breast Neoplasms (7) · Lung Neoplasms (6) · Meningeal Neoplasms (6) · Neoplasm Metastasis (3) · Central Nervous System Neoplasms (1) · Glioblastoma (1) · Glioma (1) · Melanoma (1) · Neoplasms (1) · Neoplasms by Site (1) · Nervous System Diseases (1) · Nervous System Neoplasms (1)
Central Nervous System Neoplasms (61) · Neoplasms (61) · Neoplasms by Site (61) · Nervous System Diseases (61) · Nervous System Neoplasms (61) · Meningeal Neoplasms (56) · Lung Diseases (19) · Respiratory Tract Diseases (19) · Respiratory Tract Neoplasms (19) · Thoracic Neoplasms (19) · Bronchial Neoplasms (17) · Carcinoma, Bronchogenic (17) · Lung Neoplasms (13) · Brain Diseases (10) · Central Nervous System Diseases (10)
Pemetrexed (13) · Bevacizumab (7) · Radiotherapy (6) · osimertinib (4) · Methotrexate (2) · Trastuzumab (2) · aflutinib (2) · aumolertinib (2) · pembrolizumab (2) · trastuzumab deruxtecan (2) · Capecitabine (1) · Cisplatin (1) · Cyclophosphamide (1) · Cytarabine (1) · Dexamethasone (1)
Guangzhou Medical University (6) · Second Affiliated Hospital of Nanchang University (4) · Hui Bu (3) · The First Hospital of Jilin University (3) · Cerenome (2) · Henan Cancer Hospital (2) · Memorial Sloan Kettering Cancer Center (2) · NYU Langone Health (2) · University of Zurich (2) · Beijing Tiantan Hospital (1) · Biocept, Inc. (1) · British Columbia Cancer Agency (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · Case Comprehensive Cancer Center (1) · Centre Oscar Lambret (1)
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Hui Bu (2) · Liu Anwen, Phd (2) · Zhenyu Pan, PhD,MD (2) · Zhenyu Pan, Professor (2) · Andrew Brenner, PhD (1) · Andrew Dhawan, MD, DPhil (1) · Benjamin Cooper, MD (1) · Bin Shao (1) · Brandon Imber, MD, PhD (1) · Cheryl Ho, MD (1) · Gen Lin (1) · Haibo Zhang, M.D. (1)
PMID 26827696, PMID 27243238, PMID 30059262, PMID 31809241, PMID 10501910, PMID 14059058, PMID 15117425, PMID 15118073, PMID 15118125, PMID 15886314, PMID 16391300, PMID 16642476, PMID 16855840, PMID 17308042, PMID 17374728, PMID 17894407, PMID 19470276, PMID 19738466, PMID 20087963, PMID 20573926, PMID 20689429, PMID 21599552, PMID 21874597, PMID 22487432, PMID 23354655, PMID 23717798, PMID 24002608, PMID 24893802, PMID 24893891, PMID 25142885, PMID 25175099, PMID 25784657, PMID 25850010, PMID 25921002, PMID 25928457, PMID 26334749, PMID 27209449, PMID 27412562, PMID 27539328, PMID 28105214, PMID 28627678, PMID 29151359, PMID 29190637, PMID 29307353, PMID 29700687, PMID 29782558, PMID 30039345, PMID 30429013, PMID 30524956, PMID 30975627
2019 (1), R03CA208547 (1)