Phase 3 Brain Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.
• People who are willing to give written consent and follow all study procedures for the full duration of the trial.
• People who have a reasonably good level of physical functioning, as measured by standard medical scoring tools (confirm with trial site for specific thresholds).
• People diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) who have been prescribed a type of cancer treatment called an immune checkpoint inhibitor, and who have one or more brain tumours (from the cancer spreading) that are at least 0.5 cm in size. This includes brain tumours that are newly found (where surgery or radiation can be delayed), tumours that have or have not had prior radiation treatment, or tumours that have grown back after radiation (at least 8 weeks after the last radiation treatment, or in some cases within 4 weeks if the treating doctor considers it appropriate).
• Female participants who are not planning a pregnancy during the study and who are confirmed to not be pregnant on each procedure day.
• People whose blood test results at the start of the study meet the standard requirements for receiving immune checkpoint inhibitor therapy at their treating hospital.

Who may not be able to join:

• People who have signs of active bleeding in the brain (acute intracranial hemorrhage).
• People considered at higher risk of spontaneous brain bleeding, such as those with a history of melanoma that has spread to the brain, or certain other cancer types (confirm with trial site).
• People who show signs of dangerous pressure building inside the skull, or evidence of the brain shifting or herniating (confirm with trial site).
• People currently receiving a drug called Bevacizumab (Avastin), or other medications known to increase the risk of bleeding.
• People with a history of bleeding disorders or conditions that increase the risk of bleeding during procedures.
• People with active viral infections such as Hepatitis B, Hepatitis C, or a detectable HIV level, or active bacterial infections such as tuberculosis (TB), that may interfere with the study treatment or procedures.
• People with signs of an active infection in the brain or elsewhere in the body.
• People who have previously received a transplanted organ or stem cell transplant.
• People who have received a live vaccine within 28 days before the first study treatment infusion.
• People who have a known allergy or sensitivity to the DEFINITY® ultrasound contrast agent, or to perflutren microspheres or their components (such as polyethylene glycol, found in products like MiraLAX).
• People who are unable to have an MRI scan — for example, those with certain implanted devices that are not safe for MRI use, severe claustrophobia, or an inability to lie flat in the scanner.
• People with significant liver problems, such as cirrhosis, hemochromatosis, severe alcohol-related liver damage, or active hepatitis.
• People diagnosed with an immune deficiency condition, or who are currently taking steroid medication at a dose higher than the equivalent of 10 mg of prednisone per day, or any other medication that suppresses the immune system, within 7 days before the first study treatment infusion. (Note: routine steroid use given before infusions as standard hospital practice may still be permitted — confirm with trial site.)
• People who have another type of cancer that is currently being actively treated and would interfere with the study.
• People with a known condition where cancer cells have spread into the fluid surrounding the brain and spinal cord (leptomeningeal disease).
• People with an active autoimmune disease (such as autoimmune hepatitis or Guillain-Barré Syndrome) that has required systemic medical treatment within the past 2 years. Hormone replacement therapies (such as thyroid medication or insulin) are not considered systemic treatment for this purpose. People with a history of, or current, lung inflammation (pneumonitis) that requires or required steroid treatment are also excluded.
• People with any other medical condition, past or current, that in the treating doctor's opinion could interfere with the study results or make participation not in the person's best interest.
• People who are currently participating in another clinical trial that involves an active intervention or treatment.

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