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 have been fully informed about the study and have voluntarily signed a written consent form
• Adults aged 18 or older, of any gender
• People whose general physical functioning is rated at a good to mild level (a standard performance score of 0 or 1 out of 4)
• People who have been confirmed through tissue or cell testing to have extensive-stage small cell lung cancer (a type of lung cancer that has spread widely), and who have not yet received any treatment for this stage of the disease
• People who have at least one measurable tumour site, as assessed using standard imaging measurements
• People whose blood counts meet minimum levels — including platelets, haemoglobin, and neutrophils (types of blood cells important for clotting, oxygen carrying, and fighting infection)
• People whose liver enzyme levels (ALT and AST) are within an acceptable range, regardless of whether the cancer has spread to the liver
• People whose other liver-related blood measurements (alkaline phosphatase, bilirubin) are within acceptable ranges
• People whose kidney function, as measured by creatinine levels or a calculated clearance rate, is within an acceptable range
• People whose creatine phosphokinase (a muscle-related enzyme) levels are within an acceptable range
• People whose albumin (a blood protein) level is at or above a minimum threshold
• Women who could become pregnant must have a negative blood pregnancy test before entering the trial, and must use effective contraception during treatment and for 6 months after the last dose
• Male participants whose partners could become pregnant must use effective contraception during treatment and for 4 months after the last dose
• People who test negative for HIV and do not have an active hepatitis B or hepatitis C infection

For the maintenance phase (continuing treatment after the initial cycles), people may also need to meet these additional criteria:

• People whose cancer has shown a continued response or stable disease after 4 cycles of the initial treatment, based on standard imaging measurements
• People who have recovered from any side effects of the initial treatment to a mild or minimal level
• People whose bone marrow and organ function remain at sufficient levels

Who may not be able to join:

• People who have had cancer spread to the brain or central nervous system, or have a history of this
• People who have or have had an active autoimmune disease or a condition that weakens the immune system
• People who have had a different type of cancer within the past 5 years (other than small cell lung cancer)
• People who have previously been treated with immune checkpoint inhibitor drugs or a drug called lurbinectedin
• People who have a history of a lung scarring condition (idiopathic pulmonary fibrosis), pneumonia, or who have active pneumonia detected on a CT scan
• People who have taken part in another clinical trial or received an investigational treatment within 28 days before joining

Additional exclusions for the maintenance phase:

• People who have had cancer spread to the brain or central nervous system
• People who have received chest radiotherapy as a consolidating treatment
• People who have had a serious infection within the 2 weeks before starting the maintenance phase

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