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    DRUG:

    lomustine

    i
    Other names: CCNU
    Company:
    Generic mfg.
    Drug class:
    Alkylating agent
    Related drugs:
    12d
    131I-TLX-101-003: A Phase III Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients with Recurrent Glioblastoma (2025-521785-10-00)
    P2/3, N=30, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IDH wild-type
    |
    lomustine
    14d
    VALIENT: VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Megan Mantica
    New P1 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation • IDH1 R132 • IDH2 R172
    |
    lomustine • Voranigo (vorasidenib)
    1m
    NRG-BN011: Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma (clinicaltrials.gov)
    P3, N=265, Active, not recruiting, NRG Oncology | Trial primary completion date: Aug 2026 --> Feb 2026
    Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    MGMT promoter methylation • IDH1 R132
    |
    temozolomide • lomustine
    1m
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=70, Terminated, VBI Vaccines Inc. | Recruiting --> Terminated; VBI Bankruptcy
    Trial termination
    |
    EGFR (Epidermal growth factor receptor) • MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8) • TERT (Telomerase Reverse Transcriptase) • CD4 (CD4 Molecule)
    |
    EGFR mutation • EGFR amplification • IDH wild-type
    |
    lomustine • carmustine • VBI-1901
    2ms
    Relevance of a complete re-resection of contrast enhancing tumor in MGMT promotor non-methylated versus methylated recurrent glioblastomas. (PubMed, Brain Spine)
    While lomustine chemotherapy remains the standard treatment for most patients, response is limited in MGMT non-methylated tumors...MGMT methylation correlates with improved survival. In methylated rGB, submaximal resection and poor performance status predict worse outcomes, supporting maximal resection as a key prognostic factor.
    Journal
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine
    2ms
    Advancements in Glioblastoma Multiforme Treatment: A Comprehensive Systematic Review and Meta-Analysis. (PubMed, Brain Behav)
    BEV monotherapy emerges as a promising treatment for rGBM, with favorable outcomes in biopsy results, corticosteroid use, PFS, and OS. Future research is needed to confirm these findings and optimize BEV's clinical application, emphasizing tailored treatment strategies to improve patient prognosis.
    Clinical • Retrospective data • Review • Journal
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    MGMT promoter methylation
    |
    Avastin (bevacizumab) • temozolomide • lomustine
    2ms
    High-Throughput Screening Reveals That CeeNU Acts as a New NLRP3 Inflammasome Inhibitor. (PubMed, MedComm (2020))
    Importantly, CeeNU showed remarkable protective effects in multiple mouse models of NLRP3 inflammasome-mediated diseases, including experimental autoimmune encephalomyelitis (EAE) induced by myelin oligodendrocyte glycoprotein (MOG), lipopolysaccharide (LPS)-induced septic shock, monosodium urate (MSU)-induced peritonitis, and MSU-induced gouty arthritis. Our results demonstrate that CeeNU, a clinically available drug, acts as an NLRP3 inhibitor and holds therapeutic potential for NLRP3 inflammasome-mediated pyroptotic diseases.
    Journal
    |
    NLRP3 (NLR Family Pyrin Domain Containing 3)
    |
    lomustine
    2ms
    SONOBIRD: Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (clinicaltrials.gov)
    P3, N=560, Recruiting, CarThera | Active, not recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    BRAF mutation • IDH1 R132
    |
    carboplatin • temozolomide • lomustine
    2ms
    GLIOSTELLA: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Philogen S.p.A. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lomustine • Fibromun (onfekafusp alfa)
    2ms
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=252, Active, not recruiting, CNS Pharmaceuticals, Inc. | Trial completion date: Mar 2026 --> Jul 2026
    Trial completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    doxorubicin hydrochloride • lomustine • berubicin (RTA 744)
    2ms
    Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma (clinicaltrials.gov)
    P3, N=200, Recruiting, Vastra Gotaland Region | Not yet recruiting --> Recruiting | Trial completion date: Dec 2031 --> Dec 2033 | Trial primary completion date: Dec 2028 --> Dec 2031
    Enrollment open • Trial completion date • Trial primary completion date
    |
    IDH wild-type
    |
    temozolomide • lomustine
    3ms
    Actuate 1801: 9-ING-41 in Patients With Advanced Cancers (clinicaltrials.gov)
    P2, N=350, Active, not recruiting, Actuate Therapeutics Inc. | Trial completion date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    carboplatin • gemcitabine • albumin-bound paclitaxel • irinotecan • pegylated liposomal doxorubicin • lomustine • elraglusib (9-ING-41)