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:

• A brain metastasis from non-small cell lung cancer or breast cancer has been confirmed by laboratory tissue analysis.
• Only one brain metastasis is present, measuring no more than 3 cm across, as shown on an MRI scan before surgery.
• The brain metastasis has been fully removed by surgery, confirmed by an MRI scan taken within 14 days before joining the trial.
• A specific protein marker (pSTAT3) has been detected in the brain tissue surrounding the tumour, confirmed by laboratory testing.
• Full recovery from brain surgery has been achieved, including healing of the wound and removal of stitches or staples, before joining the trial.
• The person is between 18 and 70 years of age.
• General health and ability to carry out daily activities meets a minimum score (Karnofsky score of 70 or above), assessed within 14 days before joining the trial.
• Blood, kidney, and liver function results meet minimum levels required by the trial, tested within 21 days before joining — including sufficient white blood cells, platelets, haemoglobin, kidney filtration rate, and liver enzyme levels.
• A recent heart tracing (ECG) shows no signs of acute heart problems, taken within 21 days before joining.
• People who are able to become pregnant must use at least one accepted form of contraception throughout the trial and for at least 6 months after treatment ends; male participants must also use contraception for the same period.
• A negative pregnancy test (urine or blood) has been recorded within 7 days before joining the trial, for those who could become pregnant.
• Voluntary written consent has been given before any trial-related testing or procedures begin.

Who may not be able to join:

• The specific protein marker (STAT3) is absent from the brain tissue surrounding the metastasis.
• Surgical removal of the brain metastasis was incomplete, or the metastasis measured more than 3 cm before surgery.
• The brain metastasis has previously been treated with any form of radiation therapy.
• The cancer elsewhere in the body is progressing in a way that requires a change in cancer treatment.
• A previous separate cancer diagnosis exists (other than certain skin cancers, oral cavity, or cervical cancers), unless the person has been free of that cancer for 2 or more years.
• Participation in another experimental treatment trial is planned, ongoing, or has recently occurred.
• A history of a major immune reaction has occurred.
• A known allergy or sensitivity to silibinin (the study drug) or any of its ingredients is present.
• Steroid medication cannot be given to the person.
• The person is currently pregnant or breastfeeding.
• Severe liver disease is present (based on a specific medical scoring system).
• Unstable chest pain or heart failure has occurred within the past 6 months.
• A heart attack has occurred within the past 6 months, or recent heart attack or reduced blood flow to the heart is shown on a recent ECG.
• Significant heart failure requiring hospitalisation has occurred within the past 12 months.
• A stroke, brain blood vessel event, or mini-stroke has occurred within the past 6 months.
• A serious and poorly controlled irregular heart rhythm is present.
• An active bacterial or fungal infection currently requiring intravenous antibiotics is present.
• A current flare-up of a lung condition, or other breathing illness, that requires hospitalisation or would interfere with the study treatment is present.
• An AIDS-defining illness is present.
• An active connective tissue disease (such as lupus or scleroderma) that the trial doctor considers to carry a high risk of harmful side effects is present.
• Any other serious physical illness or significant mental health condition that the trial doctor believes would prevent completion of the trial treatment is present.
• Participation in another treatment clinical trial within 30 days before joining, or during the study, is present (except certain imaging procedures without treatment intent).
• Contrast-enhanced MRI scans cannot be undergone.

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