Phase 1 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 18 years old or older
• You have been diagnosed with non-small cell lung cancer (NSCLC) that has spread or is at an advanced stage, confirmed by a biopsy or tissue test
• Your tumor has a specific gene change called the KRAS G12C mutation, confirmed by an approved lab test (either from a blood sample or tumor tissue)
• Your cancer can be measured on scans according to standard guidelines (called RECIST v1.1)
• You have already tried and your cancer stopped responding to a KRAS inhibitor medication
• You have recovered from most side effects of previous cancer treatments (hair loss is okay)
• Your overall physical functioning is reasonably maintained — you are able to care for yourself and are up and about for more than half of your waking hours (confirm with trial site)
• If you have a heart condition or have previously had heart-damaging treatments, your heart function must meet a certain minimum level as assessed by your doctor (confirm with trial site)
• If you have cancer that has spread to the brain, you may still be eligible if your doctor decides you do not need immediate brain-specific treatment right away
• Your blood counts, liver function, and kidney function must meet specific healthy levels, checked within 14 days before starting the trial
• If you could become pregnant, you must have a negative pregnancy test within 14 days before starting the trial
• If you or your partner could become pregnant, you must agree to use effective birth control or avoid sexual activity during the study and for at least 120 days after your last dose

Who may not be able to join:

• You have received chemotherapy or immunotherapy within the last 21 days
• You have had radiation therapy within the last 14 days
• You have taken a KRAS inhibitor within the last 14 days
• You have taken part in another experimental drug trial within the last 28 days (or a shorter window depending on the drug — confirm with trial site)
• You previously could not tolerate a specific dose of a drug called sotorasib (240 mg once daily)
• You have had a serious allergic reaction to a drug similar to the one being studied
• You have a significant illness that is not well controlled
• You have an active hepatitis B infection with detectable levels of the virus in your blood
• You have an untreated hepatitis C infection (if you are being treated for hepatitis C and the virus is undetectable, you may still be eligible)
• You have an active infection currently requiring antibiotic treatment
• You have HIV with a detectable amount of virus in your blood
• You have or have had another cancer that could interfere with the safety or results of this trial
• You have a serious heart condition, including severe heart failure, a heart attack in the past 6 months, or uncontrolled heart rhythm problems
• You are pregnant or currently breastfeeding
• You have any other health condition that your doctor believes would make it unsafe for you to participate
• You may not be able to follow all the study requirements and appointments

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