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 have non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body, AND your cancer has a specific genetic change called a ROS1 gene rearrangement (confirmed by a lab test)
• You are either 70 years old or older, AND/OR you have a reduced ability to carry out daily activities due to your illness (confirm with trial site)
• You are at least 18 years old
• You have at least one measurable area of cancer that can be tracked on scans, including cancer that has spread to the brain only
• You are willing and able to sign a written consent form agreeing to take part
• You have had previous chemotherapy for advanced disease, as long as at least 14 days (or a shorter period based on the drug used) have passed since stopping it, and any side effects have mostly cleared up
• You have had previous immunotherapy (such as anti-PD-1 or anti-PD-L1 treatments), as long as at least 14 days have passed since stopping it and any related side effects have mostly cleared up
• If joining the group that has never had a ROS1-targeting drug before, you must not have received one previously
• If joining the group that has already had a ROS1-targeting drug (up to 30% of participants), at least 7 days must have passed since stopping it, and side effects must have mostly cleared up; previously allowed drugs include crizotinib, ceritinib, lorlatinib, brigatinib, entrectinib, ensartinib, or cabozantinib
• You have cancer that has spread to the brain, even if you have symptoms, or have a condition called leptomeningeal carcinomatosis without symptoms
• Your doctors expect you to live for at least 3 more months
• Your blood counts and organ function (liver, kidneys, and blood clotting) meet certain minimum levels as measured by blood tests (confirm specific values with trial site)
• You are covered by an appropriate social security or health insurance system
• You are willing to use a highly effective form of contraception during the study and for a period after finishing treatment (2 months for women, 4 months for men)

Who may not be able to join:

• You have had another type of cancer within the past 2 years, unless it was a very low-risk cancer that was treated with the aim of curing it (such as certain skin cancers or early-stage cervical changes)
• You currently have active hepatitis B or hepatitis C infection (past infections that are no longer active may still be eligible — confirm with trial site)
• You currently have active tuberculosis
• You have had a serious infection requiring hospital treatment within the 2 weeks before joining the trial
• You have significant heart problems, such as a heart attack, stroke, unstable heart rhythm, or unstable chest pain within the past 3 months, or moderate-to-severe heart failure
• You have had a major surgical operation (not just for diagnosis) within 28 days before joining, or are expected to need one during the trial
• You have another medical condition, abnormal test result, or health issue that could make it unsafe for you to take the study drug or make the results hard to interpret
• You have a condition that affects your ability to understand or follow the study rules
• You are already taking part in another treatment clinical trial
• You are legally under the guardianship or authority of another person
• The trial doctor believes you are unable or unwilling to follow the study requirements

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