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 must be 18 years of age or older.
• You must be well enough to carry out light activity and care for yourself — meaning you are not confined to bed for more than half of your waking hours (confirm with trial site if unsure about this fitness level).
• You must have been diagnosed with a type of non-small cell lung cancer (NSCLC) that has a specific gene change called an STK11 mutation, confirmed by an approved lab test.
• Your cancer must have continued to grow or spread while you were being treated with a drug called pembrolizumab (or a similar immunotherapy drug), and your doctor must feel it is appropriate for you to continue that treatment.
• Your blood counts and organ function (bone marrow, kidneys, liver, and heart) must meet certain minimum levels as shown by blood tests (confirm specific values with trial site).
• Your heart must be pumping blood at a normal level, as measured by a heart scan.
• You must have at least one area of cancer that can be measured on a scan.
• If you are able to become pregnant, you must agree to use an effective form of birth control during the study, and inform your doctor immediately if you become pregnant.
• You must be willing and able to sign a consent form after having the study explained to you.
• You must be willing to provide blood samples at multiple points during the study, and provide either a fresh tumor biopsy or stored tumor tissue from a previous biopsy.

Who may not be able to join:

• You received chemotherapy within the last 4 weeks before starting the study.
• You received radiation therapy (other than for brain tumors) within the last 2 weeks, or have not fully recovered from radiation side effects.
• You have brain tumors that have not been treated, or you received whole-brain radiation or a type of targeted brain radiation less than 4 weeks ago.
• You have cancer that has spread to the lining around the brain or spinal cord (called leptomeningeal disease).
• Your lung cancer has certain other gene changes (in genes called EGFR, ALK, ROS1, RET, MET, or NTRK) identified by standard genetic testing.
• You have a history of an autoimmune disease (where the immune system attacks the body), with some exceptions such as a skin condition called vitiligo or certain hormone-related autoimmune conditions — confirm eligibility with the trial site.
• You have taken steroid medications (for immune suppression or brain metastasis management) or certain other immune-suppressing drugs within the last 4 weeks, with some limited exceptions (confirm with trial site).
• You had major surgery within the last 14 days, or have not fully recovered from a previous surgery.
• You have a known condition that weakens the immune system, such as HIV or AIDS.
• You have an active serious infection or other serious uncontrolled medical condition.
• You have a known allergy to any of the study drugs or similar medications.
• You have had a heart attack, serious blood clot in an artery, severe or unstable chest pain, or serious heart failure within the last 6 months.
• You have a history of inflammation of the heart muscle (myocarditis) at any time.
• You have a history of dangerous irregular heart rhythms (ventricular arrhythmias).
• You have uncontrolled high blood pressure that has not responded to medication.
• You have been diagnosed with another invasive cancer within the last 2 years, with some exceptions such as certain skin cancers, early-stage cancers that have not spread, or specific low-risk prostate or breast cancers (confirm with trial site).
• You are currently pregnant or breastfeeding.
• The study doctor believes, for any reason, that joining the trial would not be in your best interest.
• You are unwilling or unable to follow the requirements of the study.

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