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 are able to understand the study's purpose and have signed a written consent form before any study procedures begin.
• People who are 18 years of age or older at the time of signing the consent form.
• People who are able to swallow capsules whole, without chewing, crushing, or opening them.
• People who have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by laboratory tissue testing.
• People who have active spread of cancer to the brain, with or without symptoms.
• People whose brain metastases do not require immediate local treatment such as brain surgery or brain radiation, as determined by the local investigator.
• People with a specific type of cancer spread to the membranes surrounding the brain and spinal cord, classified as "Type II leptomeningeal disease" according to European medical guidelines (confirm with trial site).
• People who have had a confirmed ROS1 gene rearrangement, tested by a certified laboratory using an approved method before enrolling in the study.
• People who have at least one measurable brain tumour of 10mm or larger, visible on a specific type of brain MRI scan.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale called the ECOG performance status (confirm with trial site).
• People with a life expectancy of at least 6 weeks at the time of screening.
• People who have had any number of prior chemotherapy, immunotherapy, or non-ROS1 targeted therapy treatments, or people who have had no prior treatment at all.
• People who have never previously been treated with a ROS1-targeted therapy drug.
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%, as measured by a heart scan.
• People who are able to provide an archived tumour tissue sample from a previous biopsy, if one is available.
• People whose bone marrow, liver, and kidney are functioning at adequate levels as measured by recent blood tests, without recent blood transfusions or certain blood-boosting treatments in the 28 days beforehand (confirm specific values with trial site).
• People whose side effects from any previous cancer treatment have largely resolved to a mild level or better, with the exception of hair loss or other effects the investigator considers low risk.
• Women who could become pregnant and are sexually active with a male partner who has not been surgically sterilised must have a negative blood pregnancy test within 14 days before starting the study treatment, and must agree to use a highly effective non-hormonal or barrier contraception method from screening until 2 months after the last dose. They must also avoid donating eggs and breastfeeding during this period.
• Male participants who are sexually active with a female partner who could become pregnant must be surgically sterilised or use an acceptable contraception method from screening until 4 months after the last dose, and must not donate or store sperm during this period.
• People who are able to attend all required treatment visits and follow-up appointments.

Who may not be able to join:

• People who have had major surgery within four weeks before starting treatment.
• People with "Type I leptomeningeal disease" as classified by European medical guidelines.
• People who have received radiation therapy within two weeks before the first dose (or four weeks if the radiation was to the brain or spinal cord), or who still have side effects from radiation, still need steroids because of it, or have had radiation-related lung inflammation.
• People who have received any approved or experimental cancer treatment within 14 days before starting the study treatment.
• People with certain heart electrical abnormalities, including a specific heart rhythm measurement (QTc) above 470 milliseconds, significant irregular heart rhythms, or other factors that raise the risk of dangerous heart rhythm problems.
• People with significant heart or blood vessel disease that is currently active or occurred within the past 6 months, such as heart attack, unstable chest pain, heart bypass surgery, significant heart failure, stroke, mini-stroke, problematic slow heart rate, or a need for anti-irregular heartbeat medication.
• People with a known, clinically significant active infection (bacterial, fungal, or viral, including HIV) that is not being controlled with treatment.
• People with digestive conditions such as Crohn's disease, ulcerative colitis, short gut syndrome, or other conditions that would interfere with the absorption of the study drug.
• People with moderate or severe nerve damage affecting the hands or feet (peripheral neuropathy graded 2 or higher).
• People with a history of significant scarring or inflammation of the lung tissue, such as certain forms of lung fibrosis or pneumonitis — though prior radiation-related pneumonitis alone does not exclude someone.
• People with any other serious medical, psychological, or laboratory condition that the investigator believes would make participation unsafe or interfere with the study results.
• People who have had another type of cancer within the past 5 years, other than NSCLC. People with a history of certain adequately treated skin cancers or non-invasive cancers may still be considered.
• People who are currently taking or expected to need medications that strongly affect a specific liver enzyme (CYP3A) involved in processing drugs (confirm specific medications with trial site).
• People who require ongoing high-dose steroid tablets or injections (above a specific daily dose of dexamethasone) or other immune-suppressing medications, except for managing treatment side effects. Inhaled steroids and joint steroid injections are permitted.
• People who have a known allergy or sensitivity to the study drug or any of its ingredients.
• People who have taken another experimental drug within a timeframe based on how long that drug stays in the body (five times its half-life) before the screening visit.
• People who cannot have an MRI scan, including those with claustrophobia or other contraindications.

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