Clinical Trials for Brain Tumor

DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with treatment-naïve, stage IV ALK-rearranged NSCLC and asymptomatic or minimally symptomatic brain metastases are randomized to alectinib (ALK TKI with strong CNS activity) alone with delayed brain RT versus upfront stereotactic radiosurgery followed by alectinib. Designed to assess neurologic outcomes and CNS control, with a Phase 1b run-in for safety/feasibility of alectinib.

ClinicalTrials.gov ID: NCT05987644

A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with recurrent/progressive IDH–wild type glioma (WHO grade 2–4) harboring a CLIA-confirmed FGFR–TACC fusion receive oral erdafitinib monotherapy (continuous 28-day cycles) until progression/toxicity. Erdafitinib is a pan-FGFR1–4 tyrosine kinase inhibitor targeting the oncogenic FGFR–TACC fusion; prior FGFR inhibitor exposure is excluded.

ClinicalTrials.gov ID: NCT05859334

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adult patients with NSCLC and measurable brain metastases eligible for immune checkpoint inhibitor therapy are randomized to receive standard ICI treatment alone or in combination with targeted blood-brain barrier opening using Exablate focused ultrasound, a device-based method to enhance drug delivery to brain lesions.

ClinicalTrials.gov ID: NCT05317858

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with progressive, measurable CNS metastases from solid tumors and CDK pathway alterations (Cohort 1) receive palbociclib, a selective CDK4/6 inhibitor, while patients with breast cancer brain metastases (Cohort 2) receive palbociclib plus pembrolizumab, an anti–PD-1 immunotherapy. Prior CNS-directed therapy is allowed; key exclusions include prior CDK4/6 inhibitor use, leptomeningeal disease (Cohort 1), and active autoimmune disease (Cohort 2).

ClinicalTrials.gov ID: NCT02896335

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and brain metastases whose tumors have abnormally active HER2 signaling (per CELsignia test), including both ER-positive and triple-negative subtypes, and treats them with the investigational HER2 pathway inhibitor neratinib plus capecitabine. Eligible patients must have appropriate prior treatment and be able to undergo biopsy and systemic therapy.

ClinicalTrials.gov ID: NCT04965064

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with ER-positive, HER2-negative breast cancer and active, measurable brain metastases who have progressed on prior endocrine therapy (excluding prior abemaciclib in the metastatic setting), testing oral elacestrant (a selective estrogen receptor degrader) in combination with abemaciclib (a CDK4/6 inhibitor). The study excludes patients with leptomeningeal disease, imminent visceral crisis, or prior metastatic abemaciclib exposure.

ClinicalTrials.gov ID: NCT05386108

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This trial enrolls adults with advanced HRR-mutated solid tumors—including previously treated breast, ovarian, fallopian tube, primary peritoneal, castration-resistant prostate, or pancreatic cancers—who may have had limited prior PARP inhibitor exposure and CNS metastases if stable. Patients receive EIK1004 (IMP1707), a highly selective CNS-penetrant PARP1 inhibitor, as oral monotherapy.

ClinicalTrials.gov ID: NCT06907043

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Eligible patients have metastatic breast cancer with at least two untreated brain metastases (≥5 mm), are ECOG 0-1, and may continue concurrent hormonal or anti-HER2 treatment; participants receive stereotactic radiosurgery (SRS) to one lesion followed by pembrolizumab, an anti-PD-1 monoclonal antibody immunotherapy, to assess responses in non-irradiated brain lesions and systemically. Prior SRS is permitted if new lesions are targeted, and key exclusions include active autoimmune disease and recent complete CNS resection.

ClinicalTrials.gov ID: NCT03449238

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with hormone receptor positive, HER2-negative metastatic breast cancer and up to 15 brain metastases (measurable by RANO-BM and eligible for SRS) to receive abemaciclib (a CDK4/6 inhibitor), endocrine therapy, and stereotactic radiosurgery. Patients must not have prior whole brain radiotherapy, leptomeningeal disease, or recent abemaciclib exposure.

ClinicalTrials.gov ID: NCT04923542