NCT03808558

Who might be able to join this trial:

• You have been diagnosed with non-small cell lung cancer (NSCLC) that has spread or is at an advanced stage, confirmed by a lab test, and your tumor has a specific gene change called a KRAS mutation.
• Your cancer has already been treated with a standard two-drug chemotherapy combination and an immunotherapy (checkpoint inhibitor) — unless there was a medical reason you could not receive the immunotherapy — and the cancer has continued to grow or spread despite these treatments.
• Your tumor has been tested (using a tissue sample or blood test) by a certified laboratory and confirmed to have an oncogenic KRAS mutation.
• Your doctors know the status of two other gene markers (EGFR and ALK) in your tumor; if either is present, you must have already received the appropriate targeted therapy approved for those mutations.
• Your cancer is currently showing signs of getting worse on your most recent treatment.
• Your cancer can be measured on a scan using standard criteria (called RECIST v1.1).
• You are 18 years of age or older.
• You are generally well enough to carry out normal daily activities with little or no limitation (confirm with trial site — this is assessed using a scale called ECOG performance status 0 or 1).
• Your doctors expect you to live for more than 3 months.
• Your blood test results show that your bone marrow, liver, and kidneys are working well enough to meet specific thresholds set by the trial.
• Your heart is pumping adequately (heart pumping function greater than 50%) and your heart's electrical activity (measured by an ECG) is within a safe range.
• You have not had a significant heart attack or serious lack of blood flow to the heart in the past 6 months, and your heart is currently functioning adequately.
• You are willing and able to use effective birth control (hormonal, barrier method, or abstinence) during the trial and for 90 days after finishing treatment, if you are a woman who could become pregnant or a man — and you will tell your doctor immediately if you become pregnant during the study.
• You are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• You have difficulty swallowing pills, or you have a digestive condition (such as active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or problems absorbing nutrients) that could affect how your body processes the study drug.
• You have a history of a specific heart rhythm problem called torsade de pointes, uncontrolled heart failure, very low potassium levels in your blood, a condition called long QT syndrome, or you need to take medications known to affect heart rhythm during the trial.
• You need to take certain medications during the trial that strongly interact with the way the study drug is processed by the body (known as strong CYP3A4/5 agonists or inhibitors — confirm with trial site).
• You have an uncontrolled or serious ongoing medical condition, including brain metastases that are not stable (note: stable brain metastases on a steady dose of medication for at least 4 weeks may still be eligible — confirm with trial site).
• You have had major surgery within the past 4 weeks, or received cancer treatment (such as chemotherapy, radiation, immunotherapy, or another experimental drug) within the past 2 weeks (or 6 weeks for certain specific drugs), or you still have significant side effects from a previous treatment that have not resolved.
• You are currently pregnant or breastfeeding.
• You have a serious active infection that requires treatment through an intravenous (IV) drip.
• You have HIV, hepatitis B, or hepatitis C.
• You have another significant medical condition or abnormal lab result that, in your doctor's opinion, would make it unsafe for you to participate.
• You have another current or previous cancer whose history or treatment could interfere with assessing this trial's safety or effectiveness.
• You have a history of significant dry eye disease or other notable corneal (eye surface) problems, or you wear contact lenses and are unwilling to stop wearing them for the duration of the study.
• You have a known allergy or sensitivity to any component of the study drug (TVB-2640).
• You have a history of significant lung inflammation caused by a drug, radiation, or the immune system (such as immune-mediated