Phase 2 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 who are willing to take part voluntarily, have signed a consent form, and are able to attend follow-up visits.
• People aged between 18 and 75 years old.
• People who have been confirmed through a tissue or cell sample test to have extensive-stage small cell lung cancer (a type of lung cancer that has spread beyond one lung), based on recognised medical staging systems.
• People whose general physical functioning is rated as reasonably good to moderate on a standard medical scale (ECOG score of 0 to 2 — meaning the person is able to carry out at least some daily activities).
• People whose cancer did not get worse during 4 to 6 cycles of a specific combination treatment involving platinum-based chemotherapy and a medicine called Adebrelimab.
• People who have recovered well from most side effects of that earlier treatment, with only mild effects remaining (except hair loss or skin colour changes, or as assessed by the study doctor).
• People who are starting the maintenance phase of the trial within 6 weeks of finishing the last dose of the earlier treatment.
• People who have at least one area of cancer that can be measured on a scan, as assessed by the study doctor.
• People whose major organs are functioning within acceptable ranges, including blood cell counts, kidney function, liver function, and blood clotting — the trial site will assess these through blood tests.
• Women who could become pregnant must agree to use effective contraception during the study and for 6 months after it ends, must have a negative pregnancy test within one week before joining, and must not be breastfeeding. Men must also agree to use contraception during the study and for 6 months after it ends.

Who may not be able to join:

• People with limited-stage small cell lung cancer (a form of the disease that has not spread as widely).
• People whose cancer has been confirmed to be a mixed type of small cell lung cancer.
• People who have previously been treated with medicines that target blood vessel growth (anti-angiogenic therapy).
• People who have difficulty taking oral (swallowed) medication — for example, due to trouble swallowing, ongoing diarrhoea, or a bowel blockage.
• People who have had a major operation, open biopsy, or serious physical injury within 4 weeks before joining.
• People who have taken part in another clinical drug trial within 4 weeks before joining.
• People with untreated or currently symptomatic cancer that has spread to the brain or spinal cord.
• People who have another active cancer that currently requires treatment.
• People with an active autoimmune disease (where the immune system attacks the body) or immune deficiency, or a significant history of such conditions — although some stable, well-managed exceptions may be considered by the study doctor.
• People with a history of serious mental health or substance use conditions that could affect their ability to follow the study requirements.
• People with uncontrolled high blood pressure (systolic of 150 mmHg or higher, or diastolic of 100 mmHg or higher).
• People with significant heart problems, including certain irregular heart rhythms, heart failure rated as moderate or severe on a standard scale, a heart pumping function below 50%, or a history of heart attack or significant reduced blood supply to the heart.
• People with poorly controlled diabetes or other conditions that would make high-dose steroid medicines unsafe to use.
• People with a serious flare-up of a lung condition such as chronic obstructive pulmonary disease (COPD) or another serious breathing problem requiring hospitalisation.
• People with an active or uncontrolled serious infection.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining.
• People with liver cirrhosis, severe liver disease, active hepatitis, or chronic hepatitis that requires antiviral treatment.
• People with significant kidney problems shown by protein in the urine above certain measured levels.
• People who had a serious infection within 4 weeks before the first dose, or who had an unexplained high fever during the screening period or just before the first dose.
• People who experienced severe immune-related side effects (grade III or IV) during the earlier treatment phase with the PD-L1 inhibitor medicine.
• People with active cancer spread to the brain or the lining of the brain or spinal cord at the time of joining — although people whose brain metastases were previously treated and have been stable for at least 4 weeks, who are no longer on significant steroid medication and have no symptoms, may be considered eligible (confirm with trial site).
• People who the study doctor believes would be unable or unlikely to follow the study requirements.

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