Drugs / Lomustine
last change Sep 2026 re-read 8 days ago

Lomustine

also known as CCNU · CeeNu · BCNU · Gleostine · Lomustina · lomustine (CCNU) · NSC-79037

Small molecule

Developed for
glioblastoma · central nervous system neoplasm · lymphoma · malignant glioma · medulloblastoma · anaplastic astrocytoma · brain cancer · brain neoplasm
+30 more · gliosarcoma · acute myeloid leukemia · glioma · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · adult glioblastoma · anaplastic oligodendroglioma · brain glioma · brain oligodendroglioma · central nervous system cancer · cutaneous melanoma · diffuse intrinsic pontine glioma · diffuse large B-cell lymphoma · ependymoma · IDH-wildtype glioblastoma · large-cell immunoblastic lymphoma · leptomeningeal melanoma · lung cancer · melanoma · ocular melanoma · oligodendroglioma · plasma cell myeloma · precursor lymphoblastic lymphoma/leukemia · primary central nervous system lymphoma · refractory malignant neoplasm · small cell lung carcinoma · spinal cord neoplasm · urinary bladder cancer · urothelial carcinoma · central nervous system leukemia
Investigated by
National Cancer Institute (NCI) · Children's Oncology Group · Case Comprehensive Cancer Center · Philogen S.p.A. · Emory University · European Organisation for Research and Treatment of Cancer - EORTC
+90 more · M.D. Anderson Cancer Center · Memorial Sloan Kettering Cancer Center · Alliance for Clinical Trials in Oncology · Children's Cancer and Leukaemia Group · Eastern Cooperative Oncology Group · Eli Lilly and Company · NRG Oncology · North Central Cancer Treatment Group · Pfizer · Radiation Therapy Oncology Group · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University Hospital Heidelberg · University Hospital, Bonn · University Medical Center Hamburg-Eppendorf · AIDS Malignancy Consortium · Aadi Bioscience, Inc. · Aarhus University Hospital · Actuate Therapeutics Inc. · Advenchen Pharmaceuticals, LLC. · Annick Desjardins · AstraZeneca · Augusta University · Bart Neyns · Beijing Tiantan Hospital · Canadian Cancer Trials Group · Celgene Corporation · Children's Hospital of Philadelphia · Cordgenics, LLC · Deutsche Kinderkrebsstiftung · Duke University · European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma · French Innovative Leukemia Organisation · Gävle Hospital · Haukeland University Hospital · Hebei Yanda Hospital · Helse Stavanger HF · Hoffmann-La Roche · Incheon St.Mary's Hospital · Indiana University · Institute of Cancer Research, United Kingdom · Istari Oncology, Inc. · Kalmar County Hospital · Karolinska Institutet · Karyopharm Therapeutics Inc · Kepler University Hospital · Ludwig-Maximilians - University of Munich · Medical Research Council · Mundipharma Research GmbH & Co KG · NCIC Clinical Trials Group · National Cancer Center, Korea · Novartis Pharmaceuticals · OHSU Knight Cancer Institute · Oliver Jonas · Oslo University Hospital · Pediatric Oncology Group · Proximagen Limited · Region Örebro County · Riverside Haematology Group · Ruhr University of Bochum · Ryhov County Hospital · Sahlgrenska University Hospital · Saint John's Cancer Institute · Skane University Hospital · Sorlandet Hospital HF · St. Olavs Hospital · Stanford University · Sundsvalls Hospital · Tactical Therapeutics, Inc. · Telix Pharmaceuticals (Innovations) Pty Limited · The Emmes Company, LLC · The Matthew Larson Foundation for Pediatric Brain Tumors · The University of Texas Health Science Center at San Antonio · Theodore S. Johnson · all 96 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) GLEOSTINE — 1976-08-04 fda.gov ↗

Trials 73 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT05017610 Oct 2021 → Oct 2022 gliosarcoma Emory University Withdrawn No outcome recorded Stop: Enrollment
Phase 0 NCT04135807 Mar 2020 → Jan 2028 expected anaplastic astrocytoma, anaplastic oligodendroglioma, brain oligodendroglioma, glioblastoma Oliver Jonas Recruiting No outcome recorded
Phase 0 NCT02212574 Apr 2017 → Nov 2018 medulloblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 110 trials
Phase 1 NCT07145112 Oct 2025 → Mar 2027 expected glioblastoma University of California, Davis Recruiting No outcome recorded
Phase 1 NCT05304663 Jun 2022 → Dec 2024 glioblastoma Philogen S.p.A. Withdrawn No outcome recorded
Phase 1 NCT03425292 Mar 2018 → Sep 2022 malignant glioma Saint John's Cancer Institute Completed No outcome recorded
Phase 1 NCT01989052 May 2014 → Mar 2015 malignant glioma Annick Desjardins Terminated No outcome recorded Stop: Business
Phase 1 NCT01934361 Feb 2014 → Jul 2016 glioblastoma Novartis Pharmaceuticals Completed Mixed
Phase 1 NCT01563614 Mar 2012 → Nov 2015 leptomeningeal melanoma University Hospital, Bonn Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00527657 Feb 2006 → Feb 2012 brain neoplasm, melanoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01682187 Dec 2005 → May 2012 glioma Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT00006024 Nov 2000 → Jan 2005 brain glioma Children's Oncology Group Completed No outcome recorded
Phase 1 NCT00005796 Feb 2000 → Jun 2003 bone marrow disorder, central nervous system neoplasm, chemotherapy-induced toxicity Indiana University Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07811297 Sep 2026 → Sep 2030 expected endometrium neoplasm, glioblastoma, ovarian neoplasm, soft tissue sarcoma Advenchen Pharmaceuticals, LLC. Not yet recruiting No outcome recorded
Phase 1/2 NCT04573192 Feb 2021 → Mar 2025 glioblastoma Philogen S.p.A. Unknown No outcome recorded
Phase 1/2 NCT04421378 Jun 2020 → Jul 2023 glioblastoma Karyopharm Therapeutics Inc Terminated No outcome recorded
Phase 1/2 NCT02765165 Apr 2016 → Jul 2020 glioblastoma Proximagen Limited Terminated No outcome recorded Stop: Business
Phase 230 trials · 1 met primary · 1 missed
Phase 2 NCT07632209 Jun 2026 → Jun 2028 expected small cell lung carcinoma Yayi He Not yet recruiting No outcome recorded
Phase 2 NCT07120984 Jan 2026 → Jan 2029 expected glioma Philogen S.p.A. Not yet recruiting No outcome recorded
Phase 2 NCT06336291 May 2024 → Jun 2026 overdue glioblastoma Philogen S.p.A. Active not recruiting No outcome recorded
Phase 2 NCT04863950 May 2022 → Aug 2026 overdue glioblastoma The University of Texas Health Science Center at San Antonio Recruiting No outcome recorded
Phase 2 NCT04049669 Oct 2019 → Aug 2026 overdue diffuse intrinsic pontine glioma, ependymoma, glioblastoma, medulloblastoma Theodore S. Johnson Active not recruiting No outcome recorded
Phase 2 NCT03678883 Jan 2019 → Jun 2026 overdue T lymphoblastic leukemia/lymphoma, bone cancer, breast neoplasm, colorectal neoplasm +8 Actuate Therapeutics Inc. Active not recruiting Met primary
Phase 2 NCT03463265 Aug 2018 → Aug 2022 glioblastoma Aadi Bioscience, Inc. Completed No outcome recorded
Phase 2 NCT02724579 Nov 2017 → Mar 2028 expected medulloblastoma Children's Oncology Group Active not recruiting No outcome recorded
Phase 2 NCT03022578 Nov 2017 → Feb 2021 anaplastic astrocytoma, glioblastoma M.D. Anderson Cancer Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02986178 Jun 2017 → Sep 2022 malignant glioma Istari Oncology, Inc. Completed No outcome recorded
Phase 2/32 trials · 1 met primary
Phase 2/3 NCT02066220 Jun 2014 → Dec 2026 expected brain cancer University Medical Center Hamburg-Eppendorf Active not recruiting No outcome recorded
Phase 2/3 NCT00003375 Oct 1998 → Aug 2005 central nervous system neoplasm Radiation Therapy Oncology Group Completed Met primary
Phase 319 trials · 3 met primary · 5 missed
Phase 3 NCT07100730 Nov 2025 → Jul 2027 expected adult glioblastoma Telix Pharmaceuticals (Innovations) Pty Limited Recruiting No outcome recorded
Phase 3 NCT06419946 Feb 2025 → Dec 2031 expected IDH-wildtype glioblastoma Vastra Gotaland Region Recruiting No outcome recorded
Phase 3 NCT05095376 Mar 2022 → Feb 2026 overdue gliosarcoma NRG Oncology Active not recruiting No outcome recorded
Phase 3 NCT05331521 Apr 2021 → Mar 2033 expected oligodendroglioma University Hospital Heidelberg Recruiting No outcome recorded
Phase 3 NCT03632135 May 2018 → Jun 2022 glioblastoma Cordgenics, LLC Completed Met primary
Phase 3 NCT01290939 Oct 2011 → Oct 2015 cognitive disorder, glioblastoma European Organisation for Research and Treatment of Cancer - EORTC Completed Missed primary
Phase 3 NCT01149109 Oct 2010 → Apr 2017 glioblastoma University Hospital, Bonn Completed Met primary
Phase 3 NCT00887146 Sep 2009 → Oct 2029 expected central nervous system neoplasm Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 3 NCT00777153 Oct 2008 → Apr 2010 glioblastoma AstraZeneca Completed Missed primary
Phase 3 NCT00590837 Feb 2008 → Dec 2012 acute myeloid leukemia University Hospital, Bordeaux Completed No outcome recorded
Phase not applicable5 trials
— NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
— NCT02333513 Feb 2015 → Dec 2017 malignant glioma Hebei Yanda Hospital Unknown No outcome recorded
— NCT00317408 Apr 2004 → Feb 2014 lymphoma European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma Unknown No outcome recorded
— NCT00058370 Feb 2003 → Jun 2019 central nervous system neoplasm Memorial Sloan Kettering Cancer Center Completed No outcome recorded
— NCT00303810 Jan 2001 → Dec 2013 central nervous system neoplasm University Medical Center Hamburg-Eppendorf Completed No outcome recorded
Comparator or background therapy41 trials
Phase 1 NCT07629089 Background Jun 2026 → Jun 2030 expected brain cancer Megan Mantica Not yet recruiting No outcome recorded
Phase 1 NCT00503204 Background Sep 2007 → Dec 2008 brain neoplasm, glioblastoma AstraZeneca Completed No outcome recorded
Phase 1/2 NCT03382977 Comparator Dec 2017 → Jul 2025 glioblastoma VBI Vaccines Inc. Terminated No outcome recorded
Phase 1/2 NCT00948389 Comparator Oct 2009 → May 2011 glioblastoma Bristol-Myers Squibb Terminated No outcome recorded
Phase 2 NCT06816134 Comparator Jan 2025 → Jan 2028 expected acute lymphoblastic leukemia, acute myeloid leukemia The First Affiliated Hospital of Soochow University Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2025-03-25 CNS Pharmaceuticals, Inc. Results CNS Pharmaceuticals Announces Primary Analysis of Berubicin in Second Line Treatment of Glioblastoma Multiforme cnspharma.com ↗
Berubicin showed clinically relevant outcomes comparable to Lomustine across multiple endpoints, but not a statistically significant difference in overall survival, the primary endpoint.
2024-11-25 CNS Pharmaceuticals, Inc. Results CNS Pharmaceuticals Presents Update from Ongoing Potentially Pivotal Study of Berubicin Compared with Lomustine in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy cnspharma.com ↗
The data presented at the SNO Annual Meeting include comparative demographics, disposition of patients, MGMT promoter methylation status and safety, showing that the balance between the randomized arms has been maintained through enrollment of 239 patients into the study.
2024-04-03 VBI Vaccines Inc. Results VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma vbivaccines.com ↗
No tumor responses have been observed in the SoC arm
2023-11-22 CNS Pharmaceuticals, Inc. Results CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Safety Data from Ongoing Potentially Pivotal Study Evaluating Berubicin in Advance of the Pre-Planned Interim Analysis of Efficacy cnspharma.com ↗
The data presented at the SNO Annual Meeting show the comparability of the patient demographics in the two arms of the study, and of the safety data for each therapeutic modality in treating recurrent GBM.
2023-05-26 Philogen S.p.A. Results Philogen Publishes New Data on a Fibromun-based treatment combination in Science Translational Medicine in collaboration with the University Hospital Zürich philogen.com ↗
The study demonstrated that the combination Fibromun and lomustine was highly synergistic and relied on an intact immune system.
2022-12-01 Philogen S.p.A. Results Philogen provides corporate update philogen.com ↗
Fibromun shows potent activity in last-line glioblastoma in combination with Lomustine
2021-11-12 Philogen S.p.A. Results Philogen provides Corporate Update philogen.com ↗
Fibromun shows potent activity in last-line glioblastoma in combination with Lomustine
2021-07-02 Philogen S.p.A. Results Philogen Announces R&D Program Update philogen.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 119 sources stand behind the page.

FieldValueCited text
Known as Lomustine “The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin,...” NCT04135807 ↗
100

“Cumulative doses of chemotherapy drugs: cisplatin 210 mg/m2, lomustine (CCNU) 225 mg/m2, vincristine 18 mg/m2, cyclophosphamide 6 g/m2.” NCT02066220 ↗

“Induction therapy included idarubicin 8 mg/m2 on days 1 to 5, cytarabine 100 mg/m2 on days 1 to 7, and lomustine 200 mg/m2 on day 1.” PMID 28129526 ↗ Oct 2016

“Regimen A: Patients receive oral lomustine and cisplatin on day 0 and vincristine on days 0, 7, and 14” NCT00031590 ↗

“Day 1: Lomustine (CCNU) at 110 mg/m2 body surface orally,” NCT05331521 ↗

“and Dacarbazine, Lomustine, Cisplatin” NCT05898451 ↗

“lomustine (CCNU), PCV or temozolomide” NCT02678975 ↗

“Lapatinib, Lomustine, Mechlor” NCT02788201 ↗

“Lapatinib Lomustine Melphalan” NCT02551718 ↗

NCT01682187 ↗

NCT00293280 ↗

Show 90 more sources

Known as BCNU “Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin” NCT05518383 ↗
Known as CCNU “Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: * Carboplatin; * Irinotecan; * Etoposide; *...” NCT03632135 ↗
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“A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and...” NCT02765165 ↗

“mBuCy conditioning regimen(CCNU 250mg/m2/d -9d, Ara-C 2g/m2/d -8d; CDA 5 mg/m2/d -8d; Busulfan 3.2 mg/kg/d from -7 to -5 days; Cyclophosphamide 1.8 mg/m2/d from -4 to -3 days)” NCT06816134 ↗

“The impact of combined procarbazine, CCNU (lomustine), and vincristine (PCV) chemotherapy after radiotherapy (RT) compared with RT alone” PMID 18089866 ↗ Dec 2007

“patients received lomustine (CCNU) plus BEV (CCNU + BEV) or CCNU plus placebo (CCNU + placebo) until further disease progression (PD2).” PMID 30266892 ↗ Sep 2018

“The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT.” NCT05667402 ↗

“temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen” NCT00431561 ↗

“procarbazine, lomustine (CCNU), and vincristine (PCV) is active in patients with recurrent LGO/LGOA” PMID 12525516 ↗ Jan 2003

“The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.” NCT03149575 ↗

“Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade glioma” NCT03463265 ↗

“procarbazine, lomustine (also called CCNU), and vincristine” PMID 27050206 ↗ Apr 2016

Show 16 more sources

Known as CeeNu “Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy.” NCT03758014 ↗
1

“The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.” NCT03149575 ↗

Known as Gleostine “Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy.” NCT03758014 ↗
Known as Lomustina ChEMBL registry synonym — accepted as the source's own label CHEMBL514 ↗
Known as lomustine (CCNU) “lomustine (CCNU)” NCT03463265 ↗
Known as NSC-79037 ChEMBL registry synonym — accepted as the source's own label CHEMBL514 ↗
Modality Small molecule “Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents.” NCT00777153 ↗
Route Oral “oral lomustine on day 1” NCT00002569 ↗