Phase 3 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:

• A diagnosis of limited-stage small cell lung cancer (a type of lung cancer confined to one side of the chest) confirmed by a tissue or cell sample before starting first-line treatment combining chemotherapy and radiation therapy.
• The cancer responded to that first-line treatment, meaning it either completely disappeared or shrank significantly based on standard imaging measurements.
• A brain MRI scan was done within four weeks before joining the trial, showing no cancer spread to the brain or its surrounding membranes.
• A performance status score of 0–2 on a standard medical scale (meaning the person is generally able to carry out daily activities, with at most some limitations) (confirm with trial site).
• No more than 8 weeks have passed between the end of the last treatment cycle and joining the trial.
• Life expectancy estimated to be at least 12 weeks.
• Willingness to follow the study plan and attend all follow-up appointments, and having provided written consent to participate.
• Age between 18 and 75 years old (inclusive).
• People who are able to have children must agree to use highly effective contraception (with a failure rate of less than 1% per year) or remain abstinent during treatment and for at least 6 months after treatment ends.
• Blood counts within acceptable ranges: sufficient neutrophils (a type of white blood cell), platelets, haemoglobin (red blood cell protein), and blood protein levels.
• Liver function test results within acceptable limits (no more than 1.5 to 2.5 times the upper end of the normal range, depending on the specific test).
• Kidney function within acceptable limits, based on either a blood creatinine test or a calculated measure of kidney filtration rate, and minimal or no protein in the urine.
• Normal blood clotting function, or — if already on blood-thinning medication — clotting levels within the expected range for that medication.
• Women who are able to become pregnant must have a negative pregnancy test (urine-based) within 7 days before starting treatment and must not be breastfeeding.

Who may not be able to join:

• People whose small cell lung cancer has spread beyond one side of the chest (classified as "extensive stage").
• People confirmed to have cancer that has spread to the brain or its surrounding membranes before joining the trial.
• People who have had another type of cancer in the 5 years before the study — with exceptions for certain cancers considered very low risk or fully treated (such as some skin cancers, early-stage cervical cancer, localised prostate cancer, or a specific type of non-invasive breast condition, all treated with curative intent) (confirm with trial site).
• People whose previous head or neck radiation treatment overlapped with the area of the brain that would be treated in this trial.
• People for whom MRI scans are not safe or possible (for example, due to certain metal implants).
• People with serious uncontrolled health conditions that could affect their ability to follow the study plan, such as severe liver disease (like cirrhosis), uncontrolled seizures, or a condition called superior vena cava syndrome.
• People who have had a major heart event (such as a heart attack or stroke-related event), an unstable heart rhythm, or unstable chest pain within 3 months before joining — or those with known heart disease or reduced heart pumping function who are not on a stable, optimised treatment plan.
• People who have had a stroke or a temporary stroke-like episode (transient ischaemic attack) within 6 months before joining.
• People who have had significant bleeding episodes within 1 month before joining, such as gastrointestinal bleeding, stomach ulcer bleeding, active coughing up of blood, or blood vessel inflammation.
• People who have had a serious blood clot event (such as a deep vein thrombosis or pulmonary embolism) within 3 months before joining — though certain minor or catheter-related clots are not automatically disqualifying (confirm with trial site).
• People who have had diabetic ketoacidosis or a dangerous blood sugar episode within the past 6 months.
• People with a history of hypertensive crisis (a sudden, severe rise in blood pressure) or hypertensive encephalopathy (brain complications from high blood pressure).
• People with any other condition, abnormal test result, or physical finding that could affect the reliability of the study results or put the person at high risk of treatment-related complications.
• People who test positive for HIV (all participants must be tested, and a positive result means the person would not be eligible).
• People who have had major surgery within 28 days before starting the study treatment, or who are expected to need major surgery during the study (except surgery done only for diagnosis purposes).
• People who have a serious active infection at the time of study entry, including infections requiring hospital admission, bacteria in the bloodstream, or severe pneumonia.
• Women who are pregnant or breastfeeding.
• People with a significant history of serious neurological or mental health conditions — such as epilepsy, dementia, or severe depression — that could interfere with assessments.
• People whose condition, in the judgement of the treating doctor, may affect how well the study results can be measured or the person's ability to follow the study requirements.

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