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:

• Male participants must agree to use contraception during treatment and for at least 120 days after the last dose, and must not donate sperm during this time.
• Female participants must not be pregnant or breastfeeding, and must either not be of childbearing potential, or agree to use contraception during treatment and for at least 120 days after the last dose.
• People with a confirmed stage IV non-small cell lung cancer (NSCLC) diagnosis — either squamous or non-squamous type — where laboratory testing has shown the cancer cells have a protein called PD-L1 present on at least 1% of cells (confirmed through a core or surgical biopsy, not a fine needle sample).
• People whose cancer has grown or spread after receiving at least 2 doses of a type of immunotherapy called an anti-PD-(L)1 treatment (given alone or combined with other therapies), with that progression confirmed by scans at least 4 weeks apart and documented within 12 weeks of the last immunotherapy dose.
• People who have cancer that has spread to the brain, provided those brain lesions have already been treated, are considered stable on imaging, no longer require high-dose steroids, and do not involve the thin tissue lining around the brain and spinal cord.
• People with known genetic mutations driving their cancer (such as EGFR, ALK, ROS, or MET) must have already received and progressed past a treatment specifically targeting that mutation.
• People willing to receive a procedure called fecal microbiota transplant (FMT) — which involves transferring donor stool into the gut — both by swallowing capsules and through a colonoscopy or similar procedure, after understanding the associated risks.
• People with at least one measurable area of cancer visible on scans (and ideally a separate area available for biopsy), as assessed using standard measurement criteria called RECIST 1.1.
• People able to provide a fresh tissue biopsy from a tumour that has not previously been treated with radiation.
• People with a general health and activity level rated 0 or 1 on a standard scale (meaning fully active or able to carry out light work).
• People with adequate organ function based on blood tests taken within 28 days before starting the trial.
• People who have had hepatitis B may be eligible if they have been on antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining.
• People who have had hepatitis C may be eligible if they have completed antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining.

Who may not be able to join:

• People whose NSCLC is of a small cell, large cell, neuroendocrine, or sarcomatoid type.
• People who have previously received any treatment targeting the gut microbiome, including FMT, bacterial therapies, or related treatments.
• People who received chemotherapy, targeted therapy, or small molecule therapy within 2 weeks (or 4 half-lives) before the trial start date.
• People who received radiotherapy within 2 weeks before the trial start date, or who have not recovered from radiation side effects, or who have had radiation-related lung inflammation.
• People with an absolute medical reason they cannot receive FMT, including toxic megacolon, severe food allergies (such as shellfish, nuts, or seafood), or inflammatory bowel disease.
• People who have not sufficiently recovered from side effects of a previous cancer treatment.
• Women of childbearing potential with a positive pregnancy test at screening.
• People who received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, COVID-19, or typhoid) within 30 days before the first dose. Note: standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not.
• People with an immune system disorder, or who are taking high-dose steroid medication (more than 10 mg of prednisone daily) or other immune-suppressing drugs within 14 days before the first dose.
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years (hormone replacement therapy for conditions like thyroid or adrenal insufficiency is generally not considered a reason for exclusion — confirm with trial site).
• People who have had another cancer in the past 3 years, with some exceptions for low-risk or slow-growing cancers being managed by active surveillance (confirm with trial site).
• People with active, symptomatic, or growing cancer spread to the brain or to the tissue lining around the brain and spinal cord.
• People who have had a severe allergic reaction (Grade 3 or higher) to anti-PD-(L)1 immunotherapy.
• People with a systemic disease that requires steroid doses greater than 10 mg of prednisone daily (topical, inhaled, or eye drop steroids are generally not a reason for exclusion — confirm with trial site).
• People with a history of interstitial lung disease, or current or previous lung inflammation (pneumonitis) that required steroids.
• People with a history of non-infectious heart muscle inflammation, or serious heart conditions including severe heart failure, unstable chest pain, uncontrolled irregular heartbeat, or a heart attack within 6 months before the trial.
• People with any active infection requiring treatment, including active tuberculosis, active COVID-19 or recent confirmed exposure, or active HIV infection.
• People with both active hepatitis B and active hepatitis C infections at the same time.
• People with a mental health or substance use condition that would make it difficult to participate fully in the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 120 days after the last dose.
• People who have received a donor organ or tissue transplant.
• People whose overall health situation, in the treating doctor's judgement, would make trial participation unsafe or unsuitable.

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