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Alkylating agents

Lomustine + Standard Therapy for Glioblastoma

Phase 3
Recruiting
Led By Fabio M Iwamoto
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologically proven diagnosis of glioblastoma confirmed by central pathology review
IDH mutation testing with no mutation found
Must not have
History of pulmonary fibrosis
Definitive clinical or radiologic evidence of metastatic disease outside the brain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in treating newly diagnosed MGMT methylated glioblastoma.

Who is the study for?
Adults aged 18-70 with newly diagnosed MGMT methylated glioblastoma, without prior treatments except surgery. Participants must have proper liver and kidney function, no known IDH mutation or other cancers in the last two years, and be willing to use effective contraception. Excludes pregnant/nursing individuals, those with metastatic disease outside the brain, certain heart conditions, uncontrolled illnesses or infections.
What is being tested?
This phase III trial is testing if adding Lomustine to the standard treatment of Temozolomide and radiation therapy improves outcomes for patients with specific brain cancer (glioblastoma). Patients are compared between receiving this combination versus just Temozolomide and radiation.
What are the potential side effects?
Lomustine can cause fatigue, loss of appetite, nausea, vomiting; it may also lower blood cell counts increasing infection risk. Temozolomide has similar effects including headaches and constipation. Radiation therapy might lead to hair loss at treated site and skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My glioblastoma diagnosis has been confirmed by a specialized review.
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My cancer does not have an IDH mutation.
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I am able to care for myself but may not be able to do active work.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I am between 18 and 70 years old.
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I had hepatitis C but am now cured or have no detectable virus.
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My cancer does not have an IDH mutation.
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I have chronic hepatitis B but it's under control with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of lung scarring.
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My cancer has spread outside the brain.
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I am not pregnant and willing to stop nursing.
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I have had radiation therapy to my head or neck before.
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I don't have any severe illnesses that my doctor says are out of control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Incidence of Adverse Events
Patient reported outcomes for Brain Tumors
Progression Free Survival (PFS)
Other study objectives
Absolute lymphocyte counts

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Hypothyroidism
2%
Urticaria
2%
Hemorrhoids
2%
Acute kidney injury
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARM II (radiation therapy, temozolomide, lomustine)Experimental Treatment5 Interventions
Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (radiation therapy, temozolomide)Active Control4 Interventions
Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
2008
Completed Phase 3
~1690
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,468 Total Patients Enrolled
13 Trials studying Glioblastoma
3,834 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,016,493 Total Patients Enrolled
330 Trials studying Glioblastoma
23,092 Patients Enrolled for Glioblastoma
Fabio M IwamotoPrincipal InvestigatorNRG Oncology

Media Library

Lomustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05095376 — Phase 3
Glioblastoma Research Study Groups: Arm I (radiation therapy, temozolomide), ARM II (radiation therapy, temozolomide, lomustine)
Glioblastoma Clinical Trial 2023: Lomustine Highlights & Side Effects. Trial Name: NCT05095376 — Phase 3
Lomustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095376 — Phase 3
~115 spots leftby Aug 2026
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