Phase 3 Lung 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:

• People who have been diagnosed with small cell lung cancer, confirmed by a tissue or cell sample taken within the last 5 years (or more recently if the original diagnosis was longer ago than that).
• People whose small cell lung cancer is either newly diagnosed or has come back after previous treatment.
• People who have brain metastases (cancer that has spread to the brain) that are each no larger than 4 cm, are located away from a specific area of the brain called the hippocampus, and have a total combined volume of 30 cm³ or less.
• People whose brain metastases can be seen on a contrast-enhanced MRI scan taken within 21 days before joining the study.
• People aged 18 or older.
• People with a Karnofsky performance score of 70 or higher — this is a scale doctors use to measure how well a person is able to carry out daily activities (confirm with trial site).
• People whose kidneys are functioning at a sufficient level, measured by a creatinine clearance of at least 30 ml/min (confirm with trial site).
• People who have brain metastases that are not causing symptoms and are not in sensitive areas of the brain may have already started systemic treatment (such as chemotherapy or immunotherapy) before enrolling, provided a new brain MRI is done within 21 days before enrollment.
• People with brain metastases that are causing symptoms or are located in sensitive brain areas are also eligible to join, though the trial team will discuss the most appropriate treatment approach for those individuals.
• People receiving immunotherapy at the same time as brain radiation treatment are eligible.
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 14 days before registering, and both women of childbearing potential and sexually active men must use contraception during the study.
• People who have previously had surgery to remove a brain metastasis may be eligible.
• People who are fluent in English or French Canadian, as the main goal of the study involves cognitive (brain function) testing.
• People who are able to give their own informed consent to participate.
• People who have completed a set of baseline brain function tests (called HVLT-R, TMT, and COWA) within 21 days before the second registration step.

Who may not be able to join:

• People who are scheduled to receive cytotoxic chemotherapy (a type of cell-killing cancer drug) on the same day as their brain radiation treatment, or between radiation sessions if treatment is given on alternating days.
• People who have a brainstem metastasis larger than 10 cm³.
• People who have previously had an allergic reaction to a medication called memantine.
• People who have been diagnosed with leptomeningeal metastases, meaning cancer has spread to the membranes surrounding the brain and spinal cord.
• People with a known history of diseases that damage the protective covering of nerve fibres, such as multiple sclerosis.
• People who cannot have an MRI scan — for example, due to certain metal implants in the body that are not safe for MRI, an allergy to MRI contrast dye that cannot be managed with pre-medications, or other implanted objects that prevent MRI imaging.
• People currently taking any of the following medications: amantadine, ketamine, or dextromethorphan.
• People whose brain scans show a condition called hydrocephalus (a build-up of fluid in the brain) that has significantly changed the shape or position of the hippocampus, including those with a brain drain or shunt in place. Mild cases that have not distorted the hippocampus may still be eligible (confirm with trial site).
• People who have previously had any radiation treatment to the brain, including targeted radiation (SRS), whole-brain radiation (WBRT), or preventative brain radiation (prophylactic cranial irradiation).
• People who are not able to make their own decisions about participating in the study.

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