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Alkylating agents

Lomustine + Standard Therapy for Glioblastoma

Elk Grove, CA

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 5 years from radomization

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.

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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.Check my eligibility

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.See study design

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.

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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.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from radomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from radomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from radomization 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

Progression free survival (PFS)

Other study objectives

Absolute lymphocyte counts

CD4+ lymphocyte counts

Estimation of the treatment effect by ethnicity

+2 more

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 of each cycle and temozolomide PO QD on days 2-6 of each cycle. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

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 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

Lomustine

2004

Completed Phase 3

~2300