NCT05773092

Who might be able to join this trial:

• You have been diagnosed with non-small cell lung cancer (NSCLC) that has a specific gene change called an EGFR mutation, confirmed by a lab test.
• Your cancer has at least one tumor that is large enough to be measured using standard imaging scans.
• Your cancer has come back or spread, it got worse while you were being treated with a drug called osimertinib (as your most recent treatment), and your doctor plans to keep you on osimertinib.
• You have no matching genetic changes in your tumor or blood that would make you eligible for other clinical trials or approved treatments, OR you have matching genetic changes but have chosen not to pursue those other trials or treatments.
• You are 21 years of age or older.
• You are well enough to carry out some daily activities (your doctor will assess this using a standard health scale).
• Your blood counts, liver, and kidney function are within acceptable ranges based on blood tests.
• If you are living with HIV, your virus levels must be undetectable on treatment within the last 6 months, and any interactions between your HIV medications and osimertinib must have been reviewed (confirm with trial site).
• If you have chronic hepatitis B, your virus levels must be undetectable while on treatment for it.
• If you have had hepatitis C, you must have been successfully treated and cured, or if still on treatment, your virus levels must be undetectable.
• If you have had brain metastases (cancer that spread to the brain) that were treated, follow-up scans must show the cancer in the brain is not growing.
• If you have brain metastases that are not causing symptoms, your doctor must feel that no immediate brain-specific treatment is needed during the first treatment cycle.
• If you have or have had another type of cancer, it must not be expected to interfere with this trial's treatment or results.
• If you have a history of heart disease or have been treated with medications that can affect the heart, your heart function must be assessed and fall within an acceptable range on a standard heart health scale.
• Women who could become pregnant must use effective birth control, have a negative pregnancy test within 24 hours before starting treatment, and must not be breastfeeding. Men who could father a child must also use highly effective birth control.
• You are willing and able to understand and sign an informed consent form.

Who may not be able to join:

• You have had chemotherapy or radiation therapy within the past 4 weeks (or 6 weeks for certain specific drugs), or you are still experiencing significant side effects from previous cancer treatments.
• You are currently taking part in another clinical trial using an experimental treatment.
• You have brain metastases or cancer spread to the lining of the brain that is causing symptoms.
• You have previously had a serious allergic reaction to a drug that is chemically similar to S-1 (one of the drugs used in this trial).
• You are taking other medications that could dangerously interact with the trial drugs or cause overlapping harmful side effects (confirm with trial site).
• You have a serious uncontrolled illness such as an active infection, uncontrolled heart failure, unstable chest pain, irregular heartbeat, or a significant mental health condition that could affect your participation.
• You are pregnant, as both drugs used in this trial could harm an unborn baby.
• You currently have a second active cancer, unless it is a minor skin cancer, early-stage cervical, prostate, or breast cancer — or unless your other cancer has been in complete remission for at least 3 years with no further treatment needed.
• You have previously received an organ transplant or bone marrow transplant from a donor.
• You are currently incarcerated or detained in a prison or similar facility.
• You are being held involuntarily for treatment of a mental health or infectious illness.
• You are unable to follow the rules and restrictions required by this study.

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