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:

Main group (CROWN Criteria Cohort):

• People who have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) that has tested positive for an ALK gene change, confirmed through a recognised laboratory test
• People who have at least one measurable area of cancer outside the brain that has not previously been treated with radiation
• People who have brain spread (metastases) only if it is not causing symptoms and meets specific conditions around steroid use or prior treatment (confirm with trial site)
• People who have a tissue sample available from a previous biopsy, or who are able to have a new biopsy performed
• People who have not previously received any systemic treatment (such as chemotherapy, immunotherapy, targeted therapy, or ALK-blocking drugs) for advanced or metastatic lung cancer — or, if treated for an earlier stage of the disease, that treatment was completed more than 12 months ago
• People who are physically well enough to carry out daily activities with no more than moderate limitation, as measured by a standard scale (ECOG score of 0, 1, or 2)
• People aged 18 or older
• People whose blood counts are within acceptable ranges, indicating the bone marrow is functioning adequately
• People whose pancreas, kidneys, and liver are functioning within acceptable ranges based on blood tests
• People who have recovered from any side effects of previous radiation therapy
• Women who are not able to become pregnant, or women of childbearing potential who have a negative pregnancy test before starting the study
• People who have signed a consent form confirming they understand and agree to take part
• People who are willing and able to attend appointments and follow the study schedule

Compassionate Use group (for people who do not fully meet the main group criteria):

• People diagnosed with ALK-positive advanced or metastatic NSCLC who do not meet all of the main group requirements listed above
• People who have not previously been treated with an ALK-blocking drug (such as alectinib or brigatinib) for advanced or metastatic disease
• Women of childbearing potential who have a negative pregnancy test before starting the study
• People who have signed a consent form and are willing and able to follow the study schedule

Who may not be able to join:

• People with spinal cord compression that is not well controlled with treatment, or where neurological function has not been stable for at least 4 weeks
• People who have had major surgery within the 4 weeks before joining the study
• People who have received radiation therapy within the 2 weeks before joining, or whole-brain radiation within 4 weeks, or palliative radiation outside the brain within 48 hours
• People with certain stomach or bowel problems, such as being unable to swallow tablets, having had major stomach surgery, having active inflammatory bowel disease, chronic diarrhoea, or certain other digestive conditions
• People with a known serious allergic reaction to the study drug or its ingredients
• People with an active significant infection, including hepatitis B, hepatitis C, HIV, or AIDS
• People who have had a significant heart or blood vessel event within the past 3 months, such as a stroke, heart attack, unstable chest pain, blood clots, heart failure, certain abnormal heart rhythms, or specific abnormal heart readings on an ECG
• People who have conditions that may put them at risk of developing pancreatitis (inflammation of the pancreas), such as uncontrolled high blood sugar or current gallstone disease, within the past month
• People with a history of serious or widespread scarring or inflammation in the lungs (such as pulmonary fibrosis or severe interstitial lung disease)
• People who have had another active cancer (other than certain skin cancers, localised prostate cancer, or certain non-active cancers not currently needing treatment) within the past 3 years
• People who have taken certain medications that strongly interact with the study drug within the 12 days before starting — including some antifungals, antivirals, anti-seizure medications, certain heart medications, St. John's Wort, grapefruit juice, and others (confirm the full list with the trial site)
• People with serious medical or mental health conditions, including active or recent thoughts of self-harm, that the doctor believes would make participation unsafe or affect the study results
• Staff members of the trial site, their family members, or Pfizer employees directly involved in running the study
• People who are currently taking part in another clinical trial involving an experimental drug, or who have done so within the 2 weeks before joining
• Women who are pregnant or breastfeeding
• Men and women of childbearing potential who are unwilling or unable to use a highly effective method of contraception during the study and for a set period after the last dose of the study drug

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