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:

• You are at least 20 years old.
• You have been diagnosed with a type of lung cancer (non-squamous NSCLC) that has spread to other parts of the body and has a specific gene change (EGFR mutation), including mutations known as exon19 deletion, T790M, L858R, G719X, L861Q, or S768I.
• You have been diagnosed with cancer spread to the fluid or lining around the brain and spine (leptomeningeal metastasis), either confirmed or considered likely based on established medical guidelines.
• Your lung cancer has continued to grow in the brain after being treated with a drug called osimertinib, as shown by a special type of brain scan (contrast-enhanced MRI).
• Your cancer outside the brain is considered stable by your doctor.
• You are reasonably well and able to carry out daily activities (on a standard medical scale of 0–3), and your doctors expect you to live for at least 12 weeks.
• Your blood counts, liver function, and kidney function meet minimum health levels required for the trial (confirm specific values with the trial site).
• If you are a woman who could become pregnant, you agree to use a highly effective form of birth control during the study and for 5 months after the last treatment dose.
• You are able to understand the study and are willing to sign a consent form.
• You are willing to provide fluid samples from around your spine (CSF) and blood samples for genetic testing.

Who may not be able to join:

• Your cancer outside the brain is not under control and requires a treatment other than an EGFR-targeted therapy.
• You have cancer-related pain that is not well controlled.
• You have high calcium levels in your blood that are not under control; if you are currently taking a medication called denosumab, you must be willing and able to switch to a different type of bone medication during the study.
• You have had another type of cancer within the past 5 years, unless it was a very low-risk cancer that was treated with the aim of a cure (such as certain skin cancers or early-stage cervical changes — confirm with trial site).
• You are currently taking high-dose steroid medication (more than 20 mg of prednisolone per day or equivalent) or other medicines that suppress your immune system.
• You have received a live-virus vaccine within 30 days before the planned start of treatment.
• You have had standard chemotherapy or major surgery within 2 weeks before starting the study treatment.
• You currently have an active infection that requires treatment.
• You have a history of HIV infection.
• You have hepatitis B, unless you are on effective antiviral treatment with a very low virus level at the time of screening (confirm details with trial site).
• You currently have active hepatitis C.
• You have received chemotherapy injected directly into the spinal fluid within 2 weeks before starting the study treatment.
• You have received whole-brain radiation therapy within 2 weeks before starting the study treatment.
• You have epilepsy (seizures) that is not well controlled.
• You have had a serious allergic reaction to a chemotherapy drug called pemetrexed given through a drip (intravenously).
• You have a serious blood clotting problem (confirm specific values with trial site).
• You have a serious build-up of fluid in the brain (hydrocephalus) that would need a treatment other than the study treatment.
• You have a very large brain tumour that would need a treatment other than the study treatment.

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