Phase 3 Lung 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:

• People aged 18 to 75 years old (inclusive)
• People who have been diagnosed with non-small cell lung cancer (NSCLC) confirmed through a tissue sample test
• People who have brain metastases (cancer that has spread to the brain) that cause no symptoms or only mild symptoms — such as headaches, nausea, or seizures — that are being managed with medication at a stable dose for at least 3 days
• People whose brain metastases show up clearly on an MRI scan, with at least one measurable lesion and no more than 10 spots in the brain or brainstem
• People whose lung cancer has a specific genetic change in the EGFR gene (either an exon 19 deletion or an exon 21 L858R mutation), alone or alongside other EGFR mutations
• People who have not had any previous systemic (whole-body) treatment for this cancer, other than chemotherapy given before or after surgery, or alongside radiation, more than 3 months before joining the study
• People who are generally well enough to carry out normal daily activities, with a physical function score of 0 or 1 (on a standard medical scale), no worsening of condition in the past 2 weeks, and an expected survival of at least 12 weeks
• People whose blood cell counts are within acceptable ranges, without needing a blood transfusion or certain blood-boosting injections in the 7 days before testing
• People whose blood clotting levels are within acceptable ranges (or within the expected range if already on blood-thinning medication)
• People whose liver function test results are within acceptable ranges (slightly different thresholds apply if cancer has spread to the liver)
• People whose kidney function is within acceptable ranges, with low levels of protein in the urine
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 3 days before starting the study drug
• Male participants must use barrier contraception (such as condoms) from the screening stage until at least 6 months after stopping the study treatment
• People who are willing to take part voluntarily and provide written informed consent

Who may not be able to join:

• People currently taking part in another interventional clinical trial, or who have taken another experimental study drug within 4 weeks before starting this trial
• People who have previously received radiation therapy directed at the brain for palliative (symptom-relieving) purposes
• People who have had major surgery (including a biopsy) or a significant physical injury within 4 weeks before starting the study drug, or who are expected to need major surgery during the trial
• People who have previously been treated with a type of targeted therapy called an EGFR-TKI (a specific class of cancer drug)
• People whose lung cancer does not have the relevant EGFR gene changes, or who have had a severe allergic reaction (grade 3 or higher) to this type of targeted drug
• People who are unable to have an MRI scan
• People whose brain metastases require surgery to relieve pressure
• People who have previously had an organ or bone marrow transplant; who have active diverticulitis, an abdominal abscess, or a bowel blockage; or who have uncontrolled fluid build-up around the lungs or in the abdomen
• People who have had a different cancer in the past 5 years, with some exceptions such as certain treated skin cancers, early-stage cervical changes, localised prostate cancer after surgery, or non-invasive breast cancer (confirm specific exceptions with the trial site)
• People who still have ongoing side effects from previous cancer treatment rated above a mild level (with exceptions for hair loss and certain nerve-related side effects from prior chemotherapy)
• People with serious or poorly controlled medical conditions, such as a risk of active bleeding or an active infection, as assessed by the study doctor
• People with a known psychiatric illness or substance use condition that may make it difficult to follow the trial requirements
• People with a serious or uncontrolled eye condition that the study doctor considers may increase safety risks
• People with a known history of HIV infection
• People who, in the study doctor's judgement, are unlikely to be able to follow the trial procedures and requirements

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