Phase 1 Lymphoma 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 diagnosed with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be surgically removed) that has been confirmed by lab testing, and whose cancer has a specific genetic change called an ALK rearrangement.
• People who are willing to provide a fresh sample of tumor tissue (taken after their most recent cancer treatment and before starting the study drug); if this is not medically possible, an older stored tissue sample may be accepted after confirmation with the study team.
• People who have received at least one prior ALK-targeting treatment, and who meet one of these conditions: they received a drug called alectinib as their only prior ALK treatment and are unable to tolerate or are not suitable for standard second-line therapy (or the treating doctor determines they may benefit from the study drug); OR they received a drug called lorlatinib as one of their prior ALK treatments.
• People who have at least one area of cancer that can be measured on scans, according to a standard set of measurement rules used in cancer trials.
• People whose overall physical ability and daily functioning falls within a certain range on a standard medical scale (a score of 0, 1, or 2 on the ECOG scale, meaning able to carry out at least some daily activities) (confirm with trial site).
• People whose cancer has grown or come back during or after their most recent cancer treatment.
• Female participants who are not pregnant, and who either cannot become pregnant or who test negative for pregnancy within 7 days before starting the study drug and agree to use reliable contraception from the time of consent until at least 180 days after the last dose.
• Female participants who are not breastfeeding from the screening visit through to 60 days after the last dose.
• Female participants who agree not to donate eggs from the first dose through to 180 days after the last dose.
• Male participants who agree to use contraception with any female partner who could become pregnant (including a breastfeeding partner) during treatment and for 120 days after the last dose.
• Male participants who agree to either avoid sexual activity or use a condom with a pregnant partner during the study period and for 120 days after the last dose.
• Male participants who agree not to donate sperm during treatment and for 120 days after the last dose.
• People whose blood and other laboratory test results meet the specific values required by the trial (confirm with trial site for exact values).
• People who agree not to take part in any other interventional clinical trial while participating in this study.

Who may not be able to join:

• People whose cancer is driven by a genetic change other than an ALK rearrangement.
• People who have cancer that has spread to the brain or spinal fluid and is causing active symptoms.
• People who have had another type of cancer within the past 2 years, with exceptions for certain common skin cancers or cancers considered fully cured with very low chance of return.
• People who have had a major surgical procedure requiring general anaesthesia within 4 weeks before the study drug would start, or who will not have fully recovered from surgery, or who have planned surgery during the study.
• People who are still experiencing significant side effects (Grade 2 or higher, except hair loss) from a previous cancer treatment.
• People who have had a fever or an active infection (viral, bacterial, or internal fungal) in the 28 days before starting the study drug.
• People who have a history of unexplained fainting, cardiac arrest, unexplained abnormal heart rhythms, structural heart problems, or a family history of a condition called long QT syndrome.
• People who have had a stroke, mini-stroke, unstable chest pain, heart attack, or significant heart failure symptoms in the 6 months before starting the study drug.
• People who have a history of a lung condition called interstitial pneumonia.
• People who have completed targeted therapy, radiation, chemotherapy, biological therapy, or immunotherapy within 14 days before starting the study drug.
• People who need to take certain strong medications that affect how the body processes drugs (specifically, strong CYP3A inducers) (confirm with trial site for specific drug names).
• People who need to take certain medications that affect specific chemical receptors in the body (serotonin 5HT1, 5HT2B, or sigma receptors), unless those medications are considered absolutely essential for their care (confirm with trial site).
• People who have received any other experimental treatment within 14 days or within 5 half-lives of that treatment (whichever is longer) before screening.
• People whose heart electrical activity test (ECG) shows a specific measurement called QTcF greater than 450 milliseconds at screening.
• People who have an active hepatitis B or hepatitis C infection, with some exceptions for those who have been successfully treated or who have a negative DNA test result with appropriate ongoing medical management.
• People who have a known history of HIV infection with complications related to AIDS.
• People whose heart pumping function, measured by a heart scan, is below 45%.
• People who have any other health condition that the trial team determines makes participation unsafe or unsuitable.
• People who have a known or suspected allergy to the study drug (gilteritinib) or any of its ingredients.

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