Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
NCT06419946, Phase 3, Recruiting, Vastra Gotaland Region
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma | ClinicalTrials.gov |
| NCT number | NCT06419946 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vastra Gotaland Region | ClinicalTrials.gov |
| Conditions | Glioblastoma, IDH-wildtype, MGMT-Methylated Glioblastoma | ClinicalTrials.gov |
| Interventions | Temozolomide, Lomustine | ClinicalTrials.gov |
| First posted | 2024-05-17 | ClinicalTrials.gov |
| Last updated | 2026-04-13 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | overall survival | Assessed from day of randomization to event or last day of follow-up (FU). Aanlyzed 36 months after last inclusion ensures that all patients have a potential of minimum 36 months FU | visualized with Kaplan-Meier plot, tested with log-rank test | ClinicalTrials.gov |
| Secondary | progression free survival (PFS) | Assessed from day of randomization to event or last day of follow-up (FU). Aanlyzed 36 months after last inclusion ensures that all patients have a potential of minimum 36 months FU | radiological or clinical PFS according to the modified Response Assessment in Neuro-Oncology (mRANO) criteria (Kaplan-Meier plot, log-rank test) | ClinicalTrials.gov |
| Secondary | quality of life (QoL) | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | According to the EORTC Quality of Life Questionnaire (EORTC QLQ-30) with brain cancer module 20; Evaluate minimal clinically important difference (MCID) (i.e. clinically relevant difference) according to guidelines. These questionnaires contain a total of 30 + 20 QoL-related questions which are scored on a nominal scale (0-5 points); the result of each question is recorded for computerized examination and the questions relating to the same dimension of QoL (e.g. emotional well-being) are taken together for an overall score of this dimension. The scores for the different dimensions will be compared between repeated assessments throughout the trial and between the two arms of the trial. Analysed at 8 different time points: 1. start of therapy = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) | ClinicalTrials.gov |
| Secondary | neurocognition - verbal memory | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Verbal Memory Test: Participants are tasked with learning and recalling 15 words. They are asked to recognize the words among 15 distractors (other words). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall words. Low scores indicate verbal memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - visual memory | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Visual Memory Test: Participants are tasked with learning and recalling 15 geometric shapes. They are asked to recognize these among 15 distractors (other shapes). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall geometric shapes. Low scores indicate visual memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs" (CNS = central nervous system), a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - motor speed and fine motor control | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Finger Tapping Test: The test measures motor speed and fine motor control. Participants are to perform three "tapping" sessions, lightly tapping the top of a key on the computer with each hand. This test measures how many "tappings" the participant performs with each hand. Motor speed varies according to hand dominance. Low scores indicate motor slowing. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - cognitive speed | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Symbol Digit Coding: The test measures cognitive speed during simultaneous cognitive processes such as visual scanning, visual perception, visual memory, and motor skills. Low scores may indicate impulsivity, perception difficulties, or impaired processing speed. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - simple and complex reaction time, inhibition/disinhibition, mental flexibility, and focused attention. | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Stroop Test: The test measures simple and complex reaction time, inhibition/disinhibition, mental flexibility, and focused attention. It also measures how well participants can adapt to changes and increasing complexity in the task. Long reaction times indicate mental slowing. A large number of errors indicate impulsivity, perception difficulties, or impaired processing speed. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - attention | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Attention Shift Test: The test measures how well participants can shift attention and perform simultaneous tasks. Participants must adjust their responses to temporarily changed rules. Normal/good scores are achieved with a high proportion of correct answers and short reaction times. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - attention, vigilance, and reaction time | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Continuous Performance Test: The test measures attention, vigilance, and reaction time. Most normal participants achieve nearly perfect results on this test. Long response times indicate mental slowing or impaired attention. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | neurocognition - Perception | done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. | Emotional Perception Test: The test measures how well participants can perceive and identify specific emotions and their ability to perceive and understand social information. Low scores indicate difficulties with emotional perception. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. | ClinicalTrials.gov |
| Secondary | Adverse events (AE) | assessed from day of randomization to death or 36 months FU | according to the Common Terminology Criteria for Adverse Events (CTCAE). (descriptive statistics between groups). A complementary analysis of AE by severity of event and by relationship to treatment will be performed (Chi2 test). Dose reductions, delay of therapy in subsequent courses and premature withdrawals will also be described. The Pharmacovigilance Sahlgrenska University Hospital will provide an unbiased evaluation of all serious adverse events. This ensures a qualified evaluation to support the sponsor to ensure patient safety. A Data Safety Monitoring Board (DSMB) is appointed to perform pre-planned interim analyses. Prompt ad-hoc meeting of the DSMB will be held in case of suspected unexpected serious adverse events. The committee can recommend a break or the stopping of the trial. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)