Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05095376 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
A Phase 3 study of Glioblastoma and Gliosarcoma, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 265
- Enrollment target
- 20
- Study locations
NCT05095376: Active Phase 3 study of Glioblastoma and Gliosarcoma, sponsored by NRG Oncology.
NCT05095376 is a Phase 3 study of Glioblastoma and Gliosarcoma that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 265 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (145% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095376, a Phase 3 study of Glioblastoma and Gliosarcoma, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 265 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
Primary Outcome
The Kaplan-Meier method will be used to estimate survival distribution for each treatment arm.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- OTHER Questionnaire Administration
- DRUG Temozolomide
- DRUG Lomustine
- RADIATION Photon Beam Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- John Muir Medical Center-Concord - Concord
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fremont - Fremont
- Palo Alto Medical Foundation-Fremont - Fremont
- Fresno Cancer Center - Fresno
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2026-08-08 |
| Phase | Phase 3 |
What the registry record for NCT05095376 still lists
NCT05095376 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (145% higher).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT05095376 names 20 study sites across 3 states, led by California, Arkansas, Alaska.
Frequently Asked Questions
What is clinical trial NCT05095376 about?
NCT05095376 is a clinical study titled "Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma". This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to...
What is the current status of trial NCT05095376?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 265 participants. The study started on 2022-03-28. Estimated completion is 2026-08-08.
What conditions does trial NCT05095376 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma.
What interventions are being tested in trial NCT05095376?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Questionnaire Administration (OTHER), Temozolomide (DRUG), Lomustine (DRUG), Photon Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05095376?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05095376 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05095376's enrollment target sits among peer trials
265 22nd of 199 higher than 178 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
RECRUITING · Phase 3
-
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
RECRUITING · Phase 3
-
Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients
RECRUITING · Phase 3
-
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
RECRUITING · Phase 3
-
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
RECRUITING · Phase 3
-
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05443126 · 265 participants · Phase 1
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
- NCT05470491 · 265 participants · Phase 1
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
- NCT07301905 · 265 participants · NA
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
- NCT07470853 · 265 participants · Phase 1
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI