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 18 years of age or older at the time of signing the consent form
• People who can understand spoken and written language in the country where the trial is taking place
• People who have been confirmed through a tissue test (biopsy) to have a type of lung cancer called non-small cell lung cancer (NSCLC)
• People whose NSCLC has spread to other parts of the body or cannot be removed with surgery, and whose doctor has recommended starting a new round of immunotherapy
• People whose overall physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities), as assessed within 7 days before being assigned to treatment (confirm with trial site)
• People whose cancer has continued to grow after receiving immunotherapy, or immunotherapy combined with platinum-based chemotherapy
• People who received antibiotics within 60 days before or 42 days after their first immunotherapy dose, and whose cancer progressed within 6 months of that first dose
• People who have received any number of previous cancer treatments — there is no limit on prior therapies
• Male participants who agree to use contraception or avoid heterosexual activity during treatment and for at least 9 months after the last dose, and to avoid donating sperm during this time
• Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception (or avoid heterosexual activity) during treatment and for at least 180 days after the last dose, with a negative pregnancy test taken within 72 hours before the first dose if applicable
• People who are willing and able to understand, sign, and date a consent form before any trial procedures begin, and who are able to attend study visits as required
• People who are enrolled in a social security or equivalent health coverage system (this appears to be a requirement specific to the country where the trial is conducted — confirm with trial site)
• People with an estimated life expectancy of more than 3 months from the time of joining the trial
• People who, if taking steroid medications, are taking a low dose (less than the equivalent of 10 mg of prednisone per day)
• People who have at least one area of cancer that can be measured on a scan, based on standard measurement guidelines
• People whose blood tests and organ function results fall within acceptable ranges, tested within 28 days before starting the study treatment

Who may not be able to join:

• People with a weakened immune system, or who are taking steroid medications at doses higher than the equivalent of 10 mg of prednisone per day within 7 days before the first dose
• People who currently have an active infection that requires antibiotic treatment
• People who have another cancer that is currently growing or has needed active treatment within the past 3 years (though people with certain treated skin cancers or early-stage cancers that have been potentially cured may still be eligible — confirm with trial site)
• People who have had radiation therapy within 2 weeks before starting the study treatment, or who have not fully recovered from radiation side effects, or who have had radiation-related lung inflammation
• People who have received a live vaccine (such as for measles, chickenpox, yellow fever, or rabies) within 30 days before the first dose — note that standard injected flu vaccines are generally permitted, but nasal spray flu vaccines are not
• People who are currently taking part in, or have recently taken part in, another clinical trial of an unapproved treatment within 4 weeks before the first dose
• People with cancer that has actively spread to the brain or the lining around the brain — though people with previously treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site)
• People with an active autoimmune disease that has required systemic medical treatment (such as immune-suppressing drugs) within the past 2 years — note that routine hormone replacement therapies are not considered systemic treatment for this purpose
• People with a known history of HIV
• People with a known history of active Hepatitis B or active Hepatitis C infection
• People with any other medical condition, ongoing therapy, or abnormal test result that the treating doctor believes would make participation unsafe or affect the reliability of trial results
• People for whom the investigator believes participation in a clinical trial would be inappropriate or harmful
• People who are under legal guardianship, have had their freedom restricted by a legal or administrative decision, or are unable to give informed consent
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 180 days after the last dose
• People who still have side effects from previous cancer treatments that are rated above a mild level (above grade 1)
• People who have difficulty swallowing, which could affect their ability to take the oral study treatment (a stool-based therapy called MaaT033)

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