Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body, confirmed by a tissue test, where a specific marker called PD-L1 is present in fewer than 50% of tumour cells.
• People whose tumour test results show no certain gene changes (specifically negative for EGFR and ALK, and no known changes in ROS1, NTRK, RET, HER2, or MET) that would point to other targeted treatments.
• People who have not previously received systemic (whole-body) treatment for advanced or metastatic lung cancer — or, if they did receive chemotherapy or immunotherapy for earlier-stage lung cancer, the cancer did not return or spread until at least 6 months after the last treatment.
• People who have one or more measurable areas of cancer spread to the brain (brain metastases) that either have not been treated with radiation, or have clearly grown back after radiation treatment, plus at least one measurable area of cancer outside the brain.
• People whose brain metastases are not causing severe neurological symptoms requiring urgent major medical intervention, or whose symptoms have been brought under control before joining the trial — including those managed with anti-seizure medication or a low, stable dose of dexamethasone (no more than 4 mg per day for at least 1 week).
• People who have recovered from side effects of any previous cancer treatment to a mild level (Grade 1 or back to their normal baseline), with exceptions allowed for certain hormone-related side effects being managed with hormone replacement, or mild-to-moderate nerve-related side effects (Grade 2 or lower).
• People who are generally well enough to carry out light daily activities, as measured by a standard health performance scale (ECOG score of 0 or 1), assessed within 7 days before starting treatment.
• People with a life expectancy of more than 12 weeks.
• People who are able to provide a tissue sample from their tumour, either from a previous biopsy stored in a laboratory or from a new biopsy.
• People with adequate blood counts, kidney function, liver function, and blood clotting levels, as confirmed by blood tests taken within 10 days before starting treatment.
• People who have had major surgery at least 3 weeks before starting treatment, or who stopped taking chloroquine or hydroxychloroquine more than 14 days before starting.
• People with hepatitis B who have been on antiviral treatment for at least 4 weeks and have no detectable hepatitis B virus in their blood.
• People with a history of hepatitis C who have completed curative antiviral treatment at least 4 weeks before joining and have no detectable hepatitis C virus in their blood at screening.
• People living with HIV who have well-controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks before starting, with a CD4+ T-cell count of at least 350 cells/mm³ and undetectable HIV levels for at least 12 weeks before screening — and whose ART regimen does not interact with a specific enzyme pathway (CYP3A4) (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy blood test before starting the trial.
• Women of childbearing potential must be using at least one highly effective form of birth control that has been stable for at least 3 months before starting, and must continue this for at least 7 months after the last dose.
• Male participants who could father children must use contraception from screening through at least 6 months after the last dose, and their female partners of childbearing potential must also use a highly effective method of contraception.

Who may not be able to join:

• People who have received systemic cancer treatment, including experimental treatments, within 4 weeks before joining.
• People who have had radiation to the brain within the past 2 weeks, radiation to the chest within the past 4 weeks, or who are still experiencing side effects from radiation that require steroid treatment.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose.
• People who have used an experimental drug or device within 4 weeks before starting the trial.
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medication at doses higher than 10 mg of prednisone (or equivalent) per day, or any other immune-suppressing medication within 7 days before starting (low-dose dexamethasone for neurological symptoms is an exception).
• People with spinal cord compression.
• People with significant or uncontrolled heart conditions, including a dangerously irregular heart rhythm (QTcF interval above 470 msec), a heart attack within the past 6 months, uncontrolled chest pain (angina) within the past 6 months, significantly reduced heart pumping function, moderate-to-severe heart failure, or uncontrolled high blood pressure within 7 days before joining.
• People who have, or have had within the past 5 years, another cancer that is active or has required treatment — with some exceptions for certain low-risk skin cancers or very early-stage, low-risk prostate cancer (confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab, the experimental drug Dato-DXd, or any of their ingredients.
• People who have a history of lung inflammation (ILD or pneumonitis) that required steroid treatment, or who currently have or are suspected to have lung inflammation.
• People with serious lung conditions such as a pulmonary embolism within the past 3 months, severe asthma, severe oxygen-dependent COPD, restrictive lung disease, significant fluid around the lungs, or autoimmune diseases affecting the lungs.
• People with a clinically significant known eye (corneal) disease.
• People with a known active tuberculosis infection.
• People who have had a severe infection within 4 weeks before starting treatment, including infections serious enough to require hospitalisation.
• People who have taken oral or intravenous antibiotics within 2 weeks before starting treatment.
• People who have not fully recovered from major surgery, or who have ongoing complications from surgery.
• People who have a mental health condition or substance use disorder that would make it difficult to participate in the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for at least 6 months (males) or 7 months (females) after the last dose.
• People who have received an organ or tissue transplant from another person.
• People whose overall health, medical history, or other circumstances are judged by the treating doctor to make participation unsafe or likely to affect the reliability of the study results.

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