Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 (19 or older if you are in South Korea)
• You have been formally diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific gene change called an EGFR mutation
• Your cancer has continued to grow or spread after receiving standard treatments, including at least one approved EGFR-targeted therapy and/or up to one round of platinum-based chemotherapy (for one part of the study, a specific drug called Osimertinib or similar must have been included)
• Your tumor or blood test has confirmed a specific EGFR mutation (such as C797S or T790M, or others depending on which part of the study you may join), tested using a method approved by the study team
• For one part of the study (Part C), you have at least one area of cancer that can be measured on a scan and has not previously been treated with radiation
• Your general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (confirmed with trial site)
• Any side effects from previous cancer treatments have mostly cleared up or are at a mild, manageable level
• Your blood counts and organ functions (bone marrow, liver, and kidneys) meet minimum health levels as measured by blood tests (confirm specific values with trial site)
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the study, use at least one effective form of contraception from your first dose until 90 days after your last dose, and not breastfeed during the study and for 90 days after your last dose
• If you are a man who could father a child, you must agree to use effective contraception from your first dose until 90 days after your last dose, and not donate sperm during this period

Who may not be able to join:

• Your NSCLC has a mixed cell type involving squamous cells, or your cancer has transformed into a different type (such as small cell lung cancer)
• For most parts of the study, you have brain or spinal cord involvement that is uncontrolled, is actively being treated, or involves the membranes around the brain and spinal cord — unless your condition has been stable for at least 2–4 weeks after certain types of radiation treatment
• For one specific group in Part C (Cohort 4), you do not have brain metastases (spread to the brain) (confirm with trial site)
• You have recently received certain cancer treatments too close to the start of the study, including EGFR-targeted therapy within 7 days, other systemic cancer treatments within 14 days, radiation within 7–14 days, or immunotherapy within 28 days
• You have not yet recovered from a major surgery within the past 28 days
• You have certain heart problems, including an abnormal heart rhythm reading on an ECG, severely high blood pressure, severe heart failure, or a heart attack or unstable chest pain within the past 6 months (confirm specific details with trial site)
• You have had another active cancer in the past 2 years, other than certain treated skin cancers — unless you completed all cancer treatment at least 2 years ago and are considered fully cured
• You have a history of scarring or inflammation in the lungs (interstitial lung disease) or have had a lung condition that required steroid treatment
• You are unable to swallow tablets or capsules, or you have a significant digestive condition that may prevent the study drug from being properly absorbed
• You have an uncontrolled active infection such as HIV, hepatitis B or C, or active or suspected tuberculosis; or you currently have or are suspected to have an active COVID-19 infection (you may be re-screened later if you test negative)
• You have a known allergy or sensitivity to the study drug or any of its ingredients
• You have a history of substance misuse or have unstable medical, mental health, or personal circumstances that could interfere with taking part in the study
• The study doctor has determined for any reason that you may not be able to follow the study requirements

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