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 aged 18 years or older and under 80 years old, of any sex
• People diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) — confirmed through a tissue or cell sample — that has spread to the brain
• People whose lung cancer has a specific genetic change (mutation) in a gene called EGFR, including deletions in exon 19 or a change called L858R, alone or alongside other EGFR mutations
• People who have not yet received any systemic (whole-body) anti-cancer treatment for advanced or metastatic NSCLC
• People whose brain metastases are considered stable and do not need immediate or planned local treatment (such as radiation) during the study
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
• People who are relatively active and independent in daily life (rated 0 or 1 on a standard medical scale called ECOG), whose condition has not worsened in the two weeks before joining, and who are expected to live at least 3 months
• People whose blood counts, liver, kidney, and clotting functions are within acceptable ranges
• People who are able and willing to use adequate contraception from signing the consent form until 3 months after the last dose of study treatment; women of childbearing potential must have a negative pregnancy test within 7 days before the first dose
• People who have recovered from most side effects of any previous anti-cancer treatment (side effects must be mild, grade 1 or below, except hair loss or certain nerve-related effects from platinum-based treatment, which may be grade 2)
• People who are able to understand and voluntarily sign the consent form, and who are able to follow the study requirements

Who may not be able to join:

• People who have previously been treated with an EGFR inhibitor (a type of targeted therapy)
• People who have previously received systemic anti-cancer treatment, including targeted therapies, biological therapies, or immunotherapy
• People who received standard chemotherapy within 28 days before the first dose, or traditional Chinese medicine with anti-cancer properties within 7 days before the first dose
• People who have previously had whole-brain radiation therapy; or who received radiation to a large area of bone marrow within 28 days before the first dose; or who received any radiotherapy to a limited area within 7 days before the first dose, including palliative radiation for bone spread
• People with fluid build-up around the lungs, abdomen, or heart that cannot be adequately controlled
• People with cancer-related pain that is not well controlled, or who have not yet reached a stable dose of strong pain medication
• People who have had major surgery within 28 days before the first dose
• People who are taking, or have taken within 14 days before the first dose, certain medications or herbal supplements that strongly affect how the body processes a liver enzyme called CYP3A4 (confirm specific medications with the trial site)
• People who need to continue taking medications known to affect heart rhythm in a specific way (QTc interval prolongation) or that may cause a fast heartbeat
• People who have taken part in another interventional clinical trial within 28 days before the first dose
• People with primary brain tumours (cancer that started in the brain) or brain metastases that are not stable
• People who have had another type of cancer in the past 5 years, with some exceptions such as certain fully treated skin cancers, thyroid cancer, cervical carcinoma in situ, or ductal carcinoma in situ of the breast
• People experiencing spinal cord compression caused by the tumour
• People with significant digestive or gastrointestinal problems that could affect how the study drug is absorbed
• People with certain heart conditions, including a prolonged QTc interval on an ECG, significant heart rhythm abnormalities, other factors that increase heart rhythm risks, or reduced heart pumping function (LVEF below 50%)
• People with active HIV, syphilis, hepatitis C, or hepatitis B infection (people who are inactive carriers of hepatitis B or C without symptoms may still be considered — confirm with trial site)
• People with a history of a lung condition called interstitial lung disease (ILD), drug-related ILD, or radiation-related lung inflammation that required steroid treatment, or any currently active ILD
• People who have previously had an allogeneic bone marrow transplant (a transplant using donor bone marrow)
• People who are pregnant or breastfeeding
• People with any other unstable medical condition that could affect safety or the ability to follow study requirements
• People with a known allergy or sensitivity to the study drug TY-9591 or similar compounds or its ingredients

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