Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Public ClinicalTrials.gov record NCT07326566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following questions: * How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM? * What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)? * Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?
Study identification
- NCT ID
- NCT07326566
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2026
- Primary completion
- Oct 31, 2028
- Completion
- Feb 28, 2029
- Last update posted
- Sep 2, 2026
2026 – 2029
United States locations
- U.S. sites
- 29
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham O'Neal Comprehensive Cancer Center | Birmingham | Alabama | 35233 | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Stanford University | Palo Alto | California | 94304 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06510 | Recruiting |
| Johns Hopkins Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33176 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Piedmont Oncology Research | Atlanta | Georgia | 30318 | Recruiting |
| Johns Hopkins Sidney Kimmel Cancer Center - Baltimore | Baltimore | Maryland | 21287 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Cancer- Detroit | Detroit | Michigan | 48202 | Recruiting |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63108 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68106 | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | Recruiting |
| Atlantic Health | Summit | New Jersey | 07901 | Recruiting |
| Northwell Health Center for Advanced Medicine - Brain Tumor Center | Lake Success | New York | 11042 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10461 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center | Philadelphia | Pennsylvania | 19107 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Prisma Health | Greenville | South Carolina | 29605 | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07326566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07326566 live on ClinicalTrials.gov.