Phase 2 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 diagnosed with non-small cell lung cancer (NSCLC) that has spread to other parts of the body, with a specific gene change called an EGFR mutation, and who are currently being treated with the medication osimertinib as part of their regular care, with scans showing the disease is stable or better — or, if the disease has started to progress, where the treating doctor considers continuing osimertinib appropriate for at least another month.
• People whose general health and ability to carry out daily activities falls within a certain range, rated 0 to 2 on a standard medical scale (where 0 means fully active and 2 means limited in physical activity but able to care for oneself).
• People who are 18 years of age or older.
• People who are willing and able to give written consent before any study-related tests or procedures begin.
• People who are willing and able to have extra blood samples taken during the study, for example to check medication levels in the blood.
• People who are willing and able to undergo a lumbar puncture (a procedure to collect fluid from around the spine) to provide samples of cerebrospinal fluid.
• People whose use of osimertinib meets the approved conditions for that medication in the country where the study takes place.
• People who do not carry a specific genetic variation called the ABCG2 34G>A single nucleotide polymorphism (a particular inherited difference in a gene).
• People who do not have cancer that has spread to the brain or spinal cord (central nervous system metastases).
• People with hepatitis B virus (HBV) infection, provided they meet a specific set of additional medical conditions relating to the status of their infection, absence of certain other infections, and their current treatment (confirm with trial site).
• People living with HIV, provided they meet a specific set of additional conditions including undetectable virus levels, stable immune cell counts, stable HIV treatment, and no recent serious HIV-related illness (confirm with trial site).
• People who are willing to use the contraception methods specified by the trial during osimertinib treatment and for 6 weeks after the last dose — including highly effective contraception for women of childbearing potential who are sexually active with a male partner, and barrier contraception for male participants.

Who may not be able to join:

• People who currently have an acute gout attack, or have a personal medical history of gout or a condition called xanthinuria.
• People who are currently taking urate-lowering medications, or the drugs azathioprine, 6-mercaptopurine, or tioguanine.
• People who are taking certain medications that strongly affect a specific group of liver enzymes (UGT enzymes), such as rifampicin or carbamazepine.
• People who are taking other medications that moderately or strongly affect the way the body processes certain drugs, specifically those that interact with pathways known as CYP3A4 or P-glycoprotein.
• People who have previously received chemotherapy delivered directly into the fluid around the spine (intrathecal chemotherapy).
• People who have moderate or severe liver disease, classified as Child-Pugh grade B or C.
• People who have a medical condition causing their body to produce unusually high levels of uric acid, such as Lesch-Nyhan syndrome.
• People who are pregnant or currently breastfeeding.
• People who have a history of serious heart conditions, including heart attack, stroke, unstable chest pain (angina), or heart failure.
• People with certain heart rhythm or electrical abnormalities detected on a heart tracing (ECG), or with factors that increase the risk of a particular type of abnormal heart rhythm (confirm with trial site for specific thresholds).
• People with significantly reduced kidney function, based on specific blood and urine test results (confirm with trial site for exact thresholds).
• People with a known inability to process galactose, a condition called Lapp lactase deficiency, or glucose-galactose malabsorption.
• People who are directly involved in planning or running this study.
• People who still have side effects from previous cancer treatments that have not resolved, beyond a minor level, at the time of starting the study — with the exception of hair loss or a specific type of nerve-related side effect from prior platinum-based chemotherapy.
• People with severe or uncontrolled ongoing illnesses, including uncontrolled high blood pressure, active uncontrolled bleeding, active infection (including active hepatitis C or uncontrolled hepatitis B), or HIV that is not stable and controlled, if the treating doctor considers participation to be unsafe.
• People who have ongoing nausea or vomiting that cannot be controlled, chronic digestive tract disease, an inability to swallow tablets, or who have had major bowel surgery that may affect how the body absorbs medication.
• People with a history of a lung condition called interstitial lung disease, whether caused by a drug, radiation treatment, or any other cause.
• People whose blood test results show that bone marrow function, liver function, or other organ function does not meet specific minimum levels (confirm with trial site for exact values).
• People who have a known allergy or hypersensitivity to osimertinib, to another medication used in this trial called febuxostat, or to medications with a similar chemical structure to either of those drugs.
• People who are currently taking osimertinib at a dose lower than 80 mg once daily.
• People who have had another active cancer requiring systemic treatment within the 2 years before starting osimertinib.
• People who have had major surgery within 4 weeks before the first study dose (some minor procedures are permitted — confirm with trial site).
• People who have had radiation treatment covering more than 30% of the bone marrow, or a large area of radiation, within 4 weeks before the first study dose.
• People whom the treating doctor considers unlikely to be able to follow the study procedures and requirements.
• People who have taken part in another clinical trial involving an investigational (unapproved) medication within the 4 weeks before the study start date.
• People who are taking blood-thinning medications (anticoagulants) and whose treating doctor considers it unsafe or not practical to pause or adjust those medications around the time of the lumbar puncture procedure.

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