Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older.
• People whose case has been reviewed by a specialist team that includes a cancer doctor, a radiation specialist who regularly performs a precise form of radiation called SRS, and a brain surgeon.
• People whose specialist team estimates they have a life expectancy of more than 6 months.
• People whose specialist team agrees that the planned drug treatment may have a beneficial effect on the brain tumours.
• People whose specialist team agrees that the brain tumours do not need immediate surgery or radiation treatment, and that it is safe to start with drug treatment alone.
• People whose brain tumours are considered suitable for SRS (a precise form of radiation) if local treatment is needed later.
• People who have a confirmed cancer diagnosis that has spread to the brain, with at least one brain tumour measuring 5mm or larger.
• People who have at least one measurable brain tumour that has not previously been treated with SRS radiation.
• People who have previously had SRS or surgery for brain tumours may still be considered, provided at least one untreated measurable tumour remains that meets the above criteria.
• People who have had a brain tumour surgically removed, where the surgical site has either received appropriate radiation treatment or has been monitored for more than 6 months after surgery with no signs of the tumour returning in that area.
• People who have no significant neurological symptoms from their brain tumours, or whose symptoms are well controlled on a low dose of steroid medication (no more than 2mg of dexamethasone per day).
• People with a good general level of physical functioning, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose primary cancer doctor agrees that the planned drug treatment is appropriate.
• People who do not speak English may still be considered, as translation support is available.

Who may not be able to join:

• People whose cancer has spread to the lining or fluid surrounding the brain or spinal cord (known as leptomeningeal involvement).
• People whose cancer is small cell lung cancer, lymphoma, or leukaemia.
• People with a type of lung cancer (non-small cell lung cancer) that has a specific targetable genetic mutation, where the planned treatment is a highly brain-active targeted therapy (such as osimertinib, brigatinib, alectinib, or lorlatinib).
• People who have previously received whole-brain radiation therapy.
• People who have any intact brain tumour larger than 3cm. (People who have had such a tumour surgically removed and appropriately treated may still be considered if other eligible tumours are present.)
• People whose cancer has already progressed or worsened while on one or more of the drugs being studied in this trial.
• People who have received any of the study drugs within the last 30 days.
• People who previously had serious or unacceptable side effects from one or more of the study drugs.
• People with a significant medical, neurological, or psychiatric condition that would make it difficult to fully participate in the study treatment and assessments.
• People with a history of a second, separate cancer, unless treatment for that cancer was completed at least 2 years ago with no signs of it returning. (This time requirement does not apply to certain early-stage or in-situ cancers such as superficial bladder cancer, cervical cancer in situ, or ductal carcinoma in situ.)
• People with a confirmed second cancer that has spread (metastasised) from skin cancers such as basal cell carcinoma or squamous cell carcinoma.
• People who weigh more than 450 pounds (approximately 204kg).
• People who have previously received SRS radiation to any brain lesion that is less than 15mm away from a tumour visible on the screening MRI scan.
• People who are unable to have a brain MRI scan, for example due to certain implanted metal devices, or who cannot receive MRI contrast dye.
• People who have a brain tumour with a significant amount of bleeding within it, specifically where the bleeding makes up 25% or more of the tumour's largest diameter as seen on a specific type of MRI scan.

Important: Always verify eligibility with the trial site directly before applying.