Phase 2 Brain 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 who have a general health score (ECOG) of 0 to 2, meaning they are fully active to capable of limited self-care, and who are expected to live at least 3 months.
• People whose lung cancer has been confirmed through tissue or cell testing to be a specific type called non-squamous non-small cell lung cancer (NSCLC).
• People whose cancer testing has confirmed specific gene changes in the EGFR gene (called 19del or L858R mutations), found through tumour tissue, fluid samples, or blood.
• People who have brain metastases (cancer that has spread to the brain) that are either causing no symptoms, or whose symptoms have been brought under control with treatment.
• People with cancer spread to the brain or the lining of the brain, where at least one brain lesion measures 5 mm or more in diameter on an MRI scan.
• People who have not previously received systemic anti-cancer treatment for advanced or metastatic NSCLC — or people who were treated for early-stage NSCLC with surgery, chemotherapy, or radiotherapy, as long as the cancer came back more than 6 months after that treatment ended.
• People whose major organs are functioning within acceptable levels, including blood counts, liver function, kidney function, protein in the urine, blood clotting, and heart function — all meeting specific thresholds set by the trial (confirm with trial site for details).
• Women who are able to become pregnant must have a negative pregnancy test within 7 days before joining, must not be breastfeeding, and must agree to use effective contraception during the trial and for 6 months after. Male participants must also agree to use contraception during the trial and for 6 months afterward.
• People who are willing to give written consent, follow the study requirements, and participate voluntarily.

Who may not be able to join:

• People who have active bleeding in the brain or the lining of the brain.
• People who have previously been treated with certain anti-cancer medicines including bevacizumab, endostar, or anlotinib (confirm with trial site).
• People who still have side effects of Grade 2 or higher from previous cancer treatments that have not resolved before starting the study (hair loss and certain nerve-related side effects from platinum-based chemotherapy are exceptions).
• People who have ongoing problems that would prevent them from taking oral medication, such as uncontrolled nausea or vomiting, inability to swallow, bowel removal surgery, chronic diarrhoea, or bowel obstruction.
• People who have had whole-brain radiation therapy before, or who have had radiation covering more than 30% of the bone marrow, or extensive radiation within 4 weeks before starting the trial (routine palliative radiation to non-brain areas such as bones is exempt).
• People with poorly controlled high blood pressure (160/100 mmHg or higher despite treatment), or certain heart problems including abnormal heart rhythm readings, significant heart conduction issues, high risk of irregular heartbeat, or severe heart failure (NYHA Class III–IV).
• People with active or uncontrolled serious infections, severe liver disease, poorly controlled diabetes, or protein in the urine above the trial's accepted level.
• People with wounds or bone fractures that have not healed.
• People who have had significant lung bleeding within 4 weeks before joining, significant bleeding at other sites within 4 weeks before joining, known bleeding tendencies such as active stomach ulcers, or who are taking blood-thinning medicines such as warfarin or heparin.
• People who have had a blood clot, stroke, deep vein thrombosis, or pulmonary embolism within the past 12 months.
• People who have had significant coughing up of blood (more than 50 mL per day) within the past 3 months, or who have severe bleeding conditions such as gastrointestinal bleeding or vasculitis.
• People with a history of interstitial lung disease (scarring or inflammation of the lungs), including drug-related or radiation-related lung disease that required steroid treatment.
• People with a history of substance misuse or a psychiatric condition that is not well controlled.
• People with fluid build-up around the lungs or in the abdomen that cannot be controlled with treatment and is causing breathing difficulties of Grade 2 or higher.
• People with active hepatitis B, hepatitis C, active tuberculosis, syphilis, or HIV infection meeting the specific testing thresholds defined by the trial.
• People with any serious illness or condition that the trial team considers a safety risk or that could prevent them from completing the study.
• People who have previously had an allogeneic bone marrow transplant (a transplant using donor bone marrow).
• People who have had major surgery within 28 days before starting the trial, where "major surgery" means surgery that typically requires at least 3 weeks of recovery.
• People who the trial investigator considers unsuitable for any other reason.

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