Study on Cabozantinib for Patients with Specific Gene Changes in Advanced Non-Small Cell Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT01639508
This clinical trial is exploring the effects of the drug cabozantinib on patients with advanced non-small cell lung cancer that has specific gene changes, such as RET, ROS1, or NTRK fusions, or increased MET or AXL activity. The study aims to see if cabozantinib can shrink tumors and prevent them from growing.
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Program Overview
This phase II study is testing the drug cabozantinib to see how it affects patients with advanced non-small cell lung cancer that has certain gene changes. These changes can cause cancer cells to grow and spread. Cabozantinib is a pill that targets these gene changes and other pathways that help cancer grow. The goal is to shrink the cancer and stop it from spreading. Cabozantinib has been shown to shrink tumors in other types of cancer, so researchers have a good understanding of its side effects.
Eligibility Criteria
Inclusion Criteria
- Have advanced non-small cell lung cancer that cannot be removed by surgery.
- Have specific gene changes, such as RET, ROS1, or NTRK fusions, or increased MET or AXL activity.
- Be 18 years or older.
- Have measurable cancer that can be tracked using standard criteria.
- Have a performance status score of over 70%, meaning you can carry out normal activities.
- Have good organ and bone marrow function, as shown by specific blood tests.
- Be able to understand and agree to the study requirements, including signing a consent form.
- Use effective birth control during the study and for four months after the last dose if you are sexually active.
- Women must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Have taken any cancer treatment within three weeks before starting the study.
- Have had prior treatment with cabozantinib.
- Have had recent radiation therapy or ongoing complications from it.
- Have uncontrolled brain metastases or need ongoing treatment for them.
- Need to take certain blood thinners or medications that cannot be stopped.
- Have had significant bleeding or other serious health issues recently.
- Have tumors in contact with major blood vessels or in the airways.
- Have uncontrolled health conditions, such as heart problems or infections.
- Have had major surgery recently or have not fully recovered from it.
- Cannot swallow pills.
- Are pregnant or breastfeeding.
- Have allergies to the study drug.
- Cannot follow the study protocol or cooperate with the study team.
- Have another uncontrolled cancer that would interfere with the study.
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