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:

• You are willing to read and understand what the trial involves and sign a consent form agreeing to take part.
• You are 18 years of age or older.
• You have been diagnosed with advanced or spreading squamous cell carcinoma (a type of cancer) confirmed by a lab test, and you have not yet had any systemic (whole-body) treatment for it.
• Your cancer tests positive for a specific genetic change called an ALK fusion, confirmed by one of several approved lab tests.
• You are generally active and able to carry out daily activities with little or no limitation (measured by a standard performance scale called ECOG 0–1).
• Your doctors expect you to live for at least 12 weeks.
• Your blood counts and organ functions (such as liver and kidneys) are at acceptable levels.
• You have at least one area of cancer that can be measured on a scan, following specific guidelines called RECIST 1.1.
• You have brain metastases (cancer that has spread to the brain) that are currently stable and not causing active problems.

Who may not be able to join:

• You have already received systemic (whole-body) treatment for your advanced or spreading cancer.
• You have received certain targeted therapy drugs (such as EGFR or VEGFR antibody treatments) within the 4 weeks before starting the trial.
• You have had radiation therapy within 14 days before starting the trial, or you are still experiencing side effects from radiation — though some specific types of radiotherapy may be allowed if completed at least 7 days before starting (confirm with trial site).
• You are currently taking, or recently took, certain medications or herbal supplements that strongly affect how the body processes drugs (called CYP1A2 or CYP3A inhibitors or inducers) within 1–2 weeks before starting the trial (confirm with trial site).
• You have compression of the spinal cord or cancer that has spread to the membranes surrounding the brain or spinal cord.
• You have been diagnosed with another type of cancer within the past 2 years.
• You are still experiencing significant side effects (worse than mild, except for hair loss) from any previous cancer treatment.
• You have had a stroke or bleeding in the brain within the past 6 months.
• You have a serious or poorly managed health condition, such as uncontrolled high blood pressure or active bleeding.
• You have an ongoing or active infection, including hepatitis B, hepatitis C, HIV, or COVID-19.
• You have certain heart-related conditions or abnormalities (confirm with trial site for specific details).
• You have a history of serious lung inflammation or scarring conditions, including those caused by previous drug treatment, radiation, or immunotherapy.
• You have long-term nausea, vomiting, a bowel disease, difficulty swallowing, or have had bowel surgery that might prevent you from properly absorbing the trial medicines.
• You received a live vaccine within 2 weeks before starting the trial.
• You are currently pregnant or breastfeeding.
• You have a known allergy to the trial drugs or any of their ingredients.
• The trial doctors decide there is another reason you would not be suitable for the study.

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