Clinical Trials
Lomustine has been evaluated across numerous clinical trials spanning Early Phase 1 to Phase 3, focusing primarily on central nervous system malignancies including glioblastoma, recurrent glioblastoma, malignant glioma, and lymphoma. Sponsored by academic medical centers, cooperative networks such as the European Organisation for Research and Treatment of Cancer, and commercial entities like Karyopharm Therapeutics, these protocols encompass completed, actively recruiting, terminated, and withdrawn studies. Notable Phase 3 investigations evaluate lomustine as monotherapy or combination treatment in progressive and newly diagnosed methylated glioblastoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06419946 | RECRUITING | Glioblastoma, IDH-wildtype; MGMT-Methylated Glioblastoma |
Vastra Gotaland Region |
2025-02-01 | PHASE3 |
| NCT07629089 | NOT_YET_RECRUITING | Brain Cancer |
Megan Mantica |
2026-06-30 | PHASE1 |
| NCT05382338 | RECRUITING | Childhood Medulloblastoma |
Children's Oncology Group |
2023-02-20 | PHASE3 |
| NCT06177964 | RECRUITING | Recurrent Supratentorial Glioblastoma |
Darell Bigner |
2024-07-15 | PHASE2 |
| NCT06325683 | SUSPENDED | Progressive Glioblastoma; Recurrent Glioblastoma |
National Cancer Institute (NCI) |
2024-11-08 | PHASE2 |
| NCT07632209 | NOT_YET_RECRUITING | SCLC, Extensive Stage |
Yayi He |
2026-06 | PHASE2 |
| NCT03970447 | RECRUITING | Glioblastoma |
Global Coalition for Adaptive Research |
2019-07-30 | PHASE2; PHASE3 |
| NCT02724579 | ACTIVE_NOT_RECRUITING | Medulloblastoma |
Children's Oncology Group |
2017-11-17 | PHASE2 |
| NCT05902169 | RECRUITING | Glioblastoma; Recurrent Glioblastoma; GBM |
CarThera |
2024-01-29 | PHASE3 |
| NCT05904119 | RECRUITING | First Progression of Glioblastoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2024-03-15 | PHASE3 |
| NCT07100730 | RECRUITING | Neoplastic Disease; Glioblastoma; Glioblastoma (GBM); Glioblastoma Multiform; Glioblastoma Multiforme, Adult; Glioblastoma Multiforme (GBM) WHO Grade IV |
Telix Pharmaceuticals (Innovations) Pty Limited |
2025-11-02 | PHASE3 |
| NCT07145112 | RECRUITING | Glioblastoma |
University of California, Davis |
2025-10-01 | PHASE1 |
| NCT04049669 | ACTIVE_NOT_RECRUITING | Glioblastoma; Medulloblastoma; Ependymoma; Diffuse Intrinsic Pontine Glioma |
Theodore S. Johnson |
2019-10-02 | PHASE2 |
| NCT05410301 | WITHDRAWN | Glioblastoma; Recurrent Glioblastoma |
Varun Monga, MD |
2023-04 | |
| NCT04863950 | RECRUITING | Glioblastoma |
The University of Texas Health Science Center at San Antonio |
2022-05-25 | PHASE2 |
| NCT03678883 | ACTIVE_NOT_RECRUITING | Cancer; Pancreatic Cancer; Sarcoma; Renal Cancer; Refractory Cancer; Refractory Neoplasm; Refractory Non-Hodgkin Lymphoma; Pancreatic Adenocarcinoma; Resistant Cancer; Neoplasm Metastasis; Neoplasm of Bone; Neoplasm, Breast; Neoplasm of Lung; Neoplasms,Colorectal; Neoplasms Pancreatic; Malignant Glioma; Malignancies; Malignancies Multiple; Bone Metastases; Bone Neoplasm; Bone Cancer; Pancreas Cancer; Pancreatic Neoplasms; Breast Neoplasms; Acute T Cell Leukemia Lymphoma |
Actuate Therapeutics Inc. |
2019-01-04 | PHASE2 |
| NCT06336291 | ACTIVE_NOT_RECRUITING | Glioblastoma |
Philogen S.p.A. |
2024-05-22 | PHASE2 |
| NCT04762069 | ACTIVE_NOT_RECRUITING | Glioblastoma Multiforme, Adult |
CNS Pharmaceuticals, Inc. |
2021-05-18 | PHASE2 |
| NCT05095376 | ACTIVE_NOT_RECRUITING | Glioblastoma; Gliosarcoma |
NRG Oncology |
2022-03-28 | PHASE3 |
| NCT03382977 | TERMINATED | Glioblastoma Multiforme |
VBI Vaccines Inc. |
2017-12-06 | PHASE1; PHASE2 |
| NCT04402073 | TERMINATED | Medulloblastoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2022-11-11 | PHASE2 |
| NCT04573192 | UNKNOWN | Glioblastoma |
Philogen S.p.A. |
2021-02-19 | PHASE1; PHASE2 |
| NCT05326464 | COMPLETED | Glioblastoma |
University of Texas Southwestern Medical Center |
2022-10-07 | PHASE3 |
| NCT05304663 | WITHDRAWN | Glioblastoma |
Philogen S.p.A. |
2022-06-01 | PHASE1 |
| NCT05904119 | Recruiting | First Progression of Glioblastoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2024-03-15 | Phase 3 |
| NCT04421378 | TERMINATED | Glioblastoma Multiforme |
Karyopharm Therapeutics Inc |
2020-06-08 | PHASE1; PHASE2 |
| NCT02796261 | UNKNOWN | Anaplastic Astrocytoma; Recurrent Anaplastic Astrocytoma |
Orbus Therapeutics, Inc. |
2016-07 | PHASE3 |
| NCT04933942 | WITHDRAWN | First Progression of MGMT Promoter-methylated Glioblastoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2022-09-13 | PHASE2 |
| NCT05017610 | WITHDRAWN | Recurrent Glioblastoma; Recurrent Gliosarcoma |
Emory University |
2021-10-20 | EARLY_PHASE1 |
| NCT02986178 | COMPLETED | Malignant Glioma |
Istari Oncology, Inc. |
2017-06-01 | PHASE2 |
| NCT03425292 | COMPLETED | Newly Diagnosed High Grade Glioma |
Saint John's Cancer Institute |
2018-03-01 | PHASE1 |
| NCT03463265 | COMPLETED | High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma |
Aadi Bioscience, Inc. |
2018-08-01 | PHASE2 |
| NCT05304663 | Withdrawn | Glioblastoma |
Philogen S.p.A. |
2022-06-01 | Phase 1 |
| NCT03025893 | UNKNOWN | Glioblastoma Multiforme; Glioblastoma, Adult; Glioblastoma; Recurrent Brain Tumor; GBM |
Amsterdam UMC, location VUmc |
2018-08-31 | PHASE2; PHASE3 |
| NCT01775475 | COMPLETED | AIDS-related Diffuse Large Cell Lymphoma; AIDS-related Diffuse Mixed Cell Lymphoma; AIDS-related Diffuse Small Cleaved Cell Lymphoma; AIDS-related Immunoblastic Large Cell Lymphoma; AIDS-related Lymphoblastic Lymphoma; AIDS-related Peripheral/Systemic Lymphoma; AIDS-related Small Noncleaved Cell Lymphoma; Stage III AIDS-related Lymphoma; Stage IV AIDS-related Lymphoma |
AIDS Malignancy Consortium |
2016-09-15 | PHASE2 |
| NCT03022578 | TERMINATED | IDH Family Wildtype; Recurrent Anaplastic Astrocytoma; Recurrent Glioblastoma |
M.D. Anderson Cancer Center |
2017-11-07 | PHASE2 |
| NCT03758014 | UNKNOWN | GBM |
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
2018-11-27 | PHASE2; PHASE3 |
| NCT02765165 | TERMINATED | Solid Tumors (Phase 1); Relapsed/Recurrent GBM (Phase 2) |
Proximagen, LLC |
2016-04 | PHASE1; PHASE2 |
| NCT02343406 | COMPLETED | Glioblastoma |
AbbVie |
2015-02-17 | PHASE2 |
| NCT00058370 | COMPLETED | Brain and Central Nervous System Tumors |
Memorial Sloan Kettering Cancer Center |
2003-02 | |
| NCT02414165 | TERMINATED | Glioblastoma Multiforme; Anaplastic Astrocytoma |
Tocagen Inc. |
2015-11-30 | PHASE2; PHASE3 |
| NCT03149575 | TERMINATED | Glioblastoma Multiforme; Glioblastoma; Glioma; GBM; Brain Cancer |
DelMar Pharmaceuticals, Inc. |
2017-10-27 | PHASE3 |
| NCT02212574 | TERMINATED | Medulloblastoma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2017-04-04 | EARLY_PHASE1 |
| NCT01562197 | COMPLETED | Glioblastoma Multiforme |
Bart Neyns |
2014-04 | PHASE2 |
| NCT02333513 | UNKNOWN | Recurrent High-grade Glioma |
Hebei Yanda Hospital |
2015-02 | |
| NCT02926222 | COMPLETED | Glioblastoma Multiforme |
Istituto Oncologico Veneto IRCCS |
2015-11 | PHASE2 |
| NCT01149109 | COMPLETED | Glioblastoma |
University Hospital, Bonn |
2010-10 | PHASE3 |
| NCT01860638 | COMPLETED | Glioblastoma |
Hoffmann-La Roche |
2013-08-19 | PHASE2 |
| NCT01067469 | COMPLETED | Brain Cancer; Glioblastoma |
M.D. Anderson Cancer Center |
2010-01 | PHASE2 |
| NCT01934361 | COMPLETED | Recurrent Glioblastoma Multiforme |
Novartis Pharmaceuticals |
2014-02-28 | PHASE1 |
| NCT00085735 | COMPLETED | Medulloblastoma |
Children's Oncology Group |
2004-04-30 | PHASE3 |
| NCT01563614 | TERMINATED | Leptomeningeal Metastasis From Malignant Melanoma |
University Hospital, Bonn |
2012-03 | PHASE1 |
| NCT01290939 | COMPLETED | Glioblastoma Multiforme; Cognition Disorders; Disability Evaluation |
European Organisation for Research and Treatment of Cancer - EORTC |
2011-10 | PHASE3 |
| NCT01989052 | TERMINATED | Malignant Glioma (WHO Grade III or IV) |
Annick Desjardins |
2014-05 | PHASE1 |
| NCT01582269 | COMPLETED | Glioblastoma |
Eli Lilly and Company |
2012-04-26 | PHASE2 |
| NCT01989052 | Terminated | Malignant Glioma (WHO Grade III or IV) |
Annick Desjardins|Tactical Therapeutics Inc.|Duke University |
2014-05 | Phase 1 |
| NCT01562197 | Completed | Glioblastoma Multiforme |
Bart Neyns|Pfizer|Universitair Ziekenhuis Brussel |
2014-04 | Phase 2 |
| NCT00317408 | UNKNOWN | Lymphoma |
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma |
2004-04 | |
| NCT00303810 | COMPLETED | Brain and Central Nervous System Tumors |
Universitätsklinikum Hamburg-Eppendorf |
2001-01 | |
| NCT01737346 | UNKNOWN | Recurrent Glioblastoma Multiforme |
Incheon St.Mary's Hospital |
2012-10 | PHASE2 |
| NCT00590837 | COMPLETED | Acute Myeloid Leukemia |
University Hospital, Bordeaux |
2008-02 | PHASE3 |
| NCT00100802 | COMPLETED | Anaplastic Astrocytoma; Central Nervous System Neoplasm; Glioblastoma; Gliosarcoma; Spinal Cord Neoplasm |
Children's Oncology Group |
2005-03-21 | PHASE2 |
| NCT01682187 | COMPLETED | Glioma |
Eli Lilly and Company |
2005-12-15 | PHASE1 |
| NCT00527657 | COMPLETED | Brain Neoplasms; Melanoma |
M.D. Anderson Cancer Center |
2006-02-09 | PHASE1 |
| NCT00761280 | TERMINATED | Anaplastic Astrocytoma; Glioblastoma |
Isarna Therapeutics GmbH |
2008-12 | PHASE3 |
| NCT00989352 | UNKNOWN | Primary Non Hodgkin Lymphoma of the Central Nervous System |
University Hospital Freiburg |
2009-09 | PHASE2 |
| NCT00948389 | TERMINATED | Glioblastoma |
Bristol-Myers Squibb |
2009-10 | PHASE1; PHASE2 |
| NCT00031590 | TERMINATED | Brain Tumors; Central Nervous System Tumors; Medulloblastoma |
Children's Hospital of Philadelphia |
2001-04 | PHASE2 |
| NCT01149109 | Completed | Glioblastoma |
University Hospital Bonn |
2010-10 | Phase 3 |
| NCT00504660 | COMPLETED | Anaplastic Glioma of Brain; Glioblastoma Multiforme; Brain Cancer |
M.D. Anderson Cancer Center |
2003-09 | PHASE2 |
| NCT00777153 | COMPLETED | Recurrent Glioblastoma |
AstraZeneca |
2008-10 | PHASE3 |
| NCT00278278 | UNKNOWN | Brain and Central Nervous System Tumors |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
2003-09 | PHASE3 |
| NCT00274911 | UNKNOWN | Brain and Central Nervous System Tumors |
Children's Cancer and Leukaemia Group |
2004-02 | PHASE2 |
| NCT00276666 | UNKNOWN | Brain and Central Nervous System Tumors |
Children's Cancer and Leukaemia Group |
2001-11 | PHASE2 |
| NCT00503204 | COMPLETED | Recurrent Glioblastoma; Brain Tumor |
AstraZeneca |
2007-09 | PHASE1 |
| NCT00295815 | COMPLETED | Glioblastoma |
Eli Lilly and Company |
2006-01 | PHASE3 |
| NCT00293280 | COMPLETED | Lung Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2005-07 | PHASE2 |
| NCT00002875 | COMPLETED | Brain Tumors; Central Nervous System Tumors |
Children's Oncology Group |
1996-12 | PHASE3 |
| NCT00002944 | COMPLETED | Brain Tumors; Central Nervous System Tumors |
Children's Oncology Group |
1997-04 | PHASE3 |
| NCT00049439 | COMPLETED | Lymphoma |
Case Comprehensive Cancer Center |
1998-03 | PHASE2 |
| NCT00003375 | COMPLETED | Brain and Central Nervous System Tumors |
Radiation Therapy Oncology Group |
1998-10 | PHASE2; PHASE3 |
| NCT00002569 | COMPLETED | Brain and Central Nervous System Tumors |
Radiation Therapy Oncology Group |
1994-07 | PHASE3 |
| NCT00006024 | COMPLETED | Brain Tumor; Central Nervous System Tumor |
Children's Oncology Group |
2000-11 | PHASE1 |
| NCT00072345 | COMPLETED | Intraocular Melanoma; Melanoma (Skin) |
Memorial Sloan Kettering Cancer Center |
2003-07 | PHASE2 |
| NCT00005796 | COMPLETED | Bone Marrow Suppression; Brain and Central Nervous System Tumors; Drug/Agent Toxicity by Tissue/Organ |
Indiana University |
2000-02 | PHASE1 |
| NCT00002806 | COMPLETED | Brain and Central Nervous System Tumors |
Alliance for Clinical Trials in Oncology |
1996-07 | PHASE2 |
| NCT00003113 | TERMINATED | Lymphoma |
Case Comprehensive Cancer Center |
1997-07 | PHASE2 |
| NCT00003114 | COMPLETED | Lymphoma |
Case Comprehensive Cancer Center |
1997-07 | PHASE2 |
| NCT00002840 | COMPLETED | Brain and Central Nervous System Tumors |
European Organisation for Research and Treatment of Cancer - EORTC |
1996-08 | PHASE3 |
| NCT00003101 | COMPLETED | Brain and Central Nervous System Tumors |
Memorial Sloan Kettering Cancer Center |
1997-08 | PHASE2 |
| NCT00074191 | COMPLETED | Lymphoma |
OHSU Knight Cancer Institute |
2000-01 | PHASE2 |
| NCT00003929 | WITHDRAWN | Lymphoma |
Case Comprehensive Cancer Center |
1998-06 | PHASE2 |
| NCT00003788 | UNKNOWN | Brain and Central Nervous System Tumors |
Colorado Health Foundation |
1998-04 | PHASE3 |
| NCT00053872 | UNKNOWN | Brain and Central Nervous System Tumors |
University of Leicester |
2003-02 | PHASE3 |
| NCT00003603 | UNKNOWN | Multiple Myeloma and Plasma Cell Neoplasm |
Riverside Haematology Group |
1998-03 | PHASE3 |
| NCT00480064 | COMPLETED | Acute Myeloid Leukemia |
French Innovative Leukemia Organisation |
1995-07 | PHASE3 |
| NCT00052455 | COMPLETED | Brain and Central Nervous System Tumors |
Institute of Cancer Research, United Kingdom |
2002-10 | PHASE3 |
| NCT00068952 | COMPLETED | Glioblastoma |
Pfizer |
2003-08 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-04-13)
Check the
Lomustine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.