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:

• A tissue sample (from a biopsy or surgery) must be available to test for a specific protein called SLFN11, and the patient must have signed a consent form for this testing.
• The person must have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread), confirmed through laboratory analysis of tissue or cells.
• Testing must show that high levels of the SLFN11 protein are present in the tumour tissue (found in at least 20% of tumour cells when examined in a laboratory).
• The person must have already completed standard first-line treatment consisting of 4 cycles of a chemotherapy combination (platinum and etoposide) together with an immune therapy drug (atezolizumab or durvalumab); those who started the immune therapy from the second chemotherapy cycle may still meet this criterion (confirm with trial site).
• The lung cancer must not have grown or spread during or after the standard first-line treatment.
• The person must be considered suitable to continue with ongoing immune checkpoint maintenance treatment.
• Blood test results must show the blood, kidneys, and liver are functioning at an adequate level (confirm specific values with trial site).
• The person must have a general health/activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations).
• The person must be 18 years of age or older.
• Women who could potentially become pregnant must have a negative pregnancy test within 4 weeks before joining the trial, and again within 3 days before treatment starts.

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms.
• People who have another active cancer, other than small cell lung cancer — with some exceptions for certain low-risk conditions such as treated skin cancer, early-stage cervical changes, localised prostate cancer, or early uterine cancer.
• People who have previously had or currently have certain lung conditions, such as idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or who show signs of active lung inflammation on a chest scan.
• People who have any lung disease currently requiring steroid medication at doses above a certain level (confirm specific threshold with trial site).
• People who have undergone consolidating radiation treatment to the chest (note: palliative radiation to the brain or bones is permitted).
• People with serious ongoing health conditions, such as an active infection or unstable heart disease, that in the treating doctor's view could affect the person's ability to complete the trial.
• People with poorly controlled high blood pressure (above specific pressure readings), where blood pressure has not been brought under stable medical control (confirm specific values with trial site).
• People with a history of certain blood or bone marrow disorders called myelodysplastic syndrome or acute myeloid leukaemia.
• People who have previously experienced a condition called Reversible Encephalopathy Syndrome (a brain condition).
• People with severe kidney or liver impairment.
• People with significant digestive system problems that could affect how the body absorbs medication, such as malabsorption conditions or major surgical removal of parts of the stomach or bowel.
• People who have received a live vaccine within 30 days before joining the trial.
• People who have a known allergy or sensitivity to the trial drug niraparib or any of its ingredients (including tartrazine).
• Women who are pregnant or currently breastfeeding.
• Sexually active men and women who could potentially become pregnant but are unwilling to use effective contraception during the trial and for a required period after the last dose of the trial drug.
• People who, in the treating doctor's judgement, are unlikely to be able to follow the trial's procedures and requirements.

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