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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Hemorrhoids

Blurred vision

Hypothyroidism

Urticaria

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

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

~1750

Temozolomide

2010

Completed Phase 3

~1880