Phase 2 Lung 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:

• People who have been diagnosed with squamous cell lung cancer, confirmed through laboratory tissue testing.
• People whose cancer has come back (recurred) or has spread to other parts of the body (metastatic).
• People who have brain metastases (cancer that has spread to the brain) that are not causing symptoms, are small (1 cm or less), and do not require more than a low dose of a steroid medication (10 mg prednisone or equivalent).
• People who have already received a first round of treatment that included both platinum-based chemotherapy and immunotherapy, given either at the same time or one after the other.
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out everyday activities with little to moderate limitation) (confirm with trial site).
• People whose tumour shows a specific genetic change called NSD3 gain or amplification (including a change in a chromosome region called 8p11), detected by an approved genetic test.
• People whose blood test results at screening meet minimum levels for immune cells, platelets, liver function, kidney function, and blood clotting (confirm with trial site for exact values).
• People who are able to swallow capsules.
• People who are taking low-dose steroid medication (up to 10 mg prednisone daily or equivalent), as long as the dose has been stable for at least 2 weeks before starting the study drug and will stay stable throughout.
• People aged 18 years or older at the time of signing the consent form.
• Women who cannot become pregnant — either because they have gone through menopause (no periods for at least one year with no other medical explanation, confirmed by hormone levels) or have had a permanent sterilisation procedure.
• Women who could become pregnant, provided they consistently use a highly effective form of contraception (such as hormonal contraceptives, an intrauterine device, a vasectomised partner, or complete abstinence), do not donate eggs from the start of the study drug until at least 7 months after the last dose, and have a negative pregnancy test before starting.
• Men with partners who could become pregnant, provided they use a condom during sex with a pregnant partner or a partner who could become pregnant, starting from 21 days before the first dose until 4 months after the last dose, and do not donate sperm for at least 4 months after the last dose.

Who may not be able to join:

• People who have previously received an investigational BET inhibitor (a specific type of experimental drug).
• People who have received any other systemic cancer treatment or experimental therapy within 2 weeks (or five half-lives of the drug, whichever is shorter) before the first dose.
• People who have had radiation therapy within 2 weeks before the first dose.
• People currently taking certain medications that are known to strongly affect how the body processes the study drug (strong CYP3A4 inducers or inhibitors, or certain CYP1A2 substrates) — these must be stopped at least 7 days before starting the study drug (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is below 50% or below the lower limit of the treating institution's normal range.
• People with a specific abnormality in heart electrical activity (QTcF interval greater than 470 milliseconds) (confirm with trial site).
• People with known significant heart conditions, such as uncontrolled irregular heart rhythms or heart failure rated as severe (New York Heart Association class III or IV).
• People who have had a heart attack or severe chest pain (unstable angina) within the 6 months before starting the study drug.
• People with other serious uncontrolled health conditions, such as uncontrolled lung disease, active brain disease, or an active uncontrolled infection requiring treatment.
• People who have another active cancer that requires treatment at the time of joining the study.
• People with a known history of HIV, hepatitis B, or hepatitis C infection, or who have an active infection with any of these viruses (screening tests are not required, but a known positive history is exclusionary).
• People who have had major surgery (other than diagnostic procedures, dental surgery, or stenting) within 4 weeks before the first dose.
• People with a known inherited or acquired condition affecting blood clotting, including those currently taking blood-thinning (anticoagulant) medication — except for low-dose warfarin used to keep a port open.
• People currently taking, or expected to take within 7 days before the first dose or during the study, strong P-gp inhibitor medications (a specific type of drug that affects how the study drug is processed) (confirm with trial site).
• People taking oral blood-thinning medications called Factor Xa inhibitors (such as rivaroxaban or apixaban) or Factor IIa inhibitors (such as dabigatran) — low molecular weight heparin is permitted.
• Women who are breastfeeding at the time of the first dose, during the study, or within 7 months after the last dose.

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