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:

• People who have been newly diagnosed with metastatic non-small cell lung cancer (a type of lung cancer that has spread) that cannot be treated with surgery or radiotherapy aimed at a cure.
• People whose lung cancer has a specific gene change (EGFR mutation) known to respond to the drug Osimertinib — including specific types called exon 19 del, L858R, G719X, L861G, S768I, or T790M (confirm with trial site if unsure which type applies).
• People whose MRI scan shows cancer has spread to the brain, with fewer than 20 separate areas of spread visible at the time of joining the trial.
• People whose brain metastases are causing no symptoms, or only mild symptoms, at the time of joining.
• People with a general health status rated as reasonably functional (ECOG score of 2 or below) and a life expectancy of at least 6 months.
• People whose treating doctor determines they are suitable to receive Osimertinib as their EGFR-targeting treatment at the time of joining.
• People whose treating doctor determines they are suitable for a type of targeted brain radiation called stereotactic radiosurgery (SRS) at the time of joining.
• People aged 18 or older who have given written consent to participate.
• Female participants who agree to use adequate contraception until at least 6 weeks after the final dose of study treatment, are not breastfeeding, and have a negative pregnancy test before starting (or have documented evidence they cannot become pregnant, such as being post-menopausal or having had a hysterectomy, removal of both ovaries, or removal of both fallopian tubes — but not tubal ligation alone).
• Male participants who agree to use barrier contraception (such as condoms) until at least 4 months after the final dose of study treatment.

Who may not be able to join:

• People who have previously been treated with an EGFR-targeting drug (anti-EGFR TKI).
• People who have previously received immunotherapy checkpoint inhibitor treatment for metastatic lung cancer.
• People who have previously had whole-brain radiation or stereotactic radiosurgery (SRS) to the brain.
• People currently taking medications or herbal supplements that strongly affect how the body processes certain drugs (known as potent CYP3A4 inducers), unless these can be stopped within the required timeframe before starting Osimertinib.
• People who have taken an experimental drug within a certain recent timeframe before joining (five half-lives of that drug — confirm timeframe with trial site).
• People who have received chemotherapy, other experimental cancer treatments, or anticancer drugs from a previous treatment or trial within 14 days of joining.
• People whose cancer (outside the brain) has continued to grow or spread while on Osimertinib between the screening scan and the scan done before joining the trial.
• People with spinal cord compression, unless it is causing no symptoms and is considered stable.
• People with cancer that has spread to the lining of the brain or spinal cord (leptomeningeal disease).
• People with moderate to severe brain metastasis symptoms — specifically, symptoms serious enough to require hospitalisation, or involving paralysis, coma, or frequent seizures despite medication.
• People with serious uncontrolled health conditions such as uncontrolled high blood pressure, active uncontrolled bleeding, or active infections including hepatitis B, hepatitis C, or HIV, where the treating doctor considers participation unsuitable.
• People with ongoing severe nausea or vomiting, chronic digestive conditions, an inability to swallow tablets, or a history of major bowel surgery that could prevent the body from absorbing Osimertinib properly.
• People who are directly involved in planning or running the trial.
• People who, in the treating doctor's judgement, are unlikely to follow the trial's procedures and requirements.

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