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:

• Adults aged 18 or older at the time of signing the consent form.
• People who are generally well enough to carry out light activity and care for themselves (a doctor will assess this using a standard fitness scale).
• People with an estimated life expectancy of 12 weeks or more.
• People who have been diagnosed with a specific type of advanced lung cancer (metastatic non-squamous non-small cell lung cancer, or NSCLC) confirmed by pathology testing.
• People without a targetable genetic mutation in their cancer who have already had their cancer worsen during or after immunotherapy and/or platinum-based chemotherapy; or, if immunotherapy was medically not suitable, after platinum-based chemotherapy.
• People with a targetable genetic mutation in their cancer who have already had their cancer worsen during or after targeted therapy and platinum-based chemotherapy (prior immunotherapy is allowed but not required for this group).
• People whose brain metastases (cancer that has spread to the brain) are not located in a particularly sensitive part of the brain — all participants will need to be reviewed by a neurologist, and ideally discussed in a specialist brain tumour team meeting.
• People whose individual brain metastases are each no larger than 2 cm at their widest point.
• People with at least one untreated brain metastasis measuring 5 mm or more (those with lesions between 5 mm and less than 10 mm may be considered with the agreement of the lead investigator and will require a specific type of detailed brain MRI scan).
• People who have had prior local treatment to the brain are eligible if that treated area has since clearly shown new growth, or if new brain metastases have appeared since treatment.
• People who, for at least 7 days before the first dose of study treatment, have had no symptoms from their brain metastases, have been on a stable and low dose of steroid medication (no more than 4 mg of dexamethasone per day), and have been on a stable dose of any anti-seizure medication.
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better (with exceptions for hair loss and nerve-related symptoms, which may be at any level).
• People whose blood test results at the screening visit show that the liver, kidneys, and blood cells are functioning at an acceptable level (the trial site will assess specific values).
• People who are able to follow instructions about taking study medication and can communicate with the research team.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must agree to use effective contraception — specifically a physical barrier method plus either an intrauterine device or hormonal contraception — for at least 4 months after finishing the study treatment.

Who may not be able to join:

• People whose cancer has spread to the lining around the brain or spinal cord (leptomeningeal metastasis), based on MRI or fluid testing.
• People who have previously been treated with a TROP2-targeting drug or a drug that blocks blood vessel growth (anti-angiogenesis therapy).
• People with a known serious allergy or hypersensitivity to any of the study drugs or their ingredients.
• Women who are pregnant or currently breastfeeding.
• People for whom an MRI scan is medically not suitable.
• People who have had a bone marrow or solid organ transplant from another person.
• People who received a biological cancer drug (such as an antibody-drug conjugate or immunotherapy) within the 4 weeks before enrolment, or chemotherapy, targeted therapy, or radiation therapy within 2 weeks before enrolment, and have not adequately recovered from side effects of those treatments.
• People who have not sufficiently recovered from side effects of any previous cancer treatment (exceptions apply for skin colour changes such as vitiligo, and hair loss). People who have had major surgery must have sufficiently recovered before starting treatment.
• People who currently have another active cancer. People whose previous cancer was fully treated with no signs of active disease for at least 3 years, or whose previous cancer was surgically removed and carries a low risk of returning (for example, certain skin cancers or fully removed early-stage cancers), may still be considered.
• People who have experienced any of the following heart conditions: a heart attack or unstable chest pain within the past 6 months; a history of serious heart rhythm problems or a prolonged QT interval; or heart failure classified as moderate to severe, or a significantly reduced heart pumping function.
• People with active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or a hole in the bowel within the past 6 months.
• People with an active serious infection currently requiring antibiotic treatment.
• People with a known history of HIV with a detectable level of virus in the blood, or who are taking medications that could interfere with how the study drug is processed by the body.
• People with active hepatitis B or hepatitis C virus infection, or a history of either with a currently detectable viral load.
• People with other ongoing medical or mental health conditions that, in the investigator's opinion, could affect the reliability of the study results or prevent the person from completing the study.
• People with any medical condition that, in the investigator's or sponsor's opinion, poses an unacceptable risk from joining the study.
• People who have taken another experimental drug (not approved for any condition) within 28 days or 5 half-lives of that drug — whichever is longer — before the first dose of study treatment.
• People with serious lung problems, including a blood clot in the lung within the past month, severe asthma, severe chronic obstructive pulmonary disease, restricted lung function, uncontrolled fluid around the lungs, certain autoimmune conditions affecting the lungs, or who have had a lung surgically removed.
• People with blood pressure that is not adequately controlled (above 150/100 mmHg) — though blood pressure medication to bring it within range is permitted.
• People with a history of a severe high blood pressure crisis or high blood pressure affecting the brain.
• People with significant blood vessel disease (for example, a large aortic aneurysm needing surgery, or a recent blood clot in a limb artery) within the past 6 months.
• People who have coughed up a notable amount of bright red blood within the past month.
• People with a known bleeding disorder or problem with blood clotting (when not related to treatment with anticoagulant medication).
• People currently taking high-dose aspirin (more than 325 mg per day) or certain other blood-thinning medications (dipyridamole, ticlopidine, clopidogrel, or cilostazol) at or within 10 days before starting treatment.
• People on full-dose blood thinners or clot-dissolving medications whose dose has not been stable for at least 2 weeks before starting treatment (stable, therapeutic use within acceptable ranges may be permitted — confirm with trial site).
• People who have had a core biopsy or minor surgical procedure (other than placement of a vascular access device) within 7 days before the first dose of one of the study drugs (bevacizumab).
• People with a history of certain abnormal connections between internal organs (fistula) or a hole in the bowel within the past 6 months.
• People with signs of a bowel blockage, or who routinely need intravenous fluids, intravenous nutrition, or tube feeding.
• People with unexplained free air in the abdomen not accounted for by a recent procedure or surgery.
• People with a serious wound that has not healed, an active ulcer, or an untreated broken bone.
• People with significant levels of protein detected in their urine (the trial site will assess this with urine tests).
• People whose imaging shows the cancer has clearly grown into major blood vessels in the chest.
• People whose imaging shows clear breakdown (cavitation) of lung tumour lesions.

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