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:

• People aged 18 or older who live in a European country and are of European descent.
• People who have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced, has spread to other parts of the body, or has come back after previous treatment, and cannot be fully treated with surgery or radiation therapy.
• People whose lung cancer has a specific gene change (mutation) called ex19del, L858R, or T790M, confirmed by a laboratory test on tumor tissue or a blood sample.
• People who have not yet received any cancer treatment for their advanced disease, provided their tumor has an ex19del or L858R gene mutation.
• People who previously received treatment aimed at curing an earlier-stage cancer (before it spread), as long as that treatment finished at least 12 months before the cancer came back or spread, and their tumor has an ex19del or L858R gene mutation.
• People who received only one course of an earlier type of targeted therapy (first- or second-generation EGFR-TKI) for advanced disease, whose cancer has since been shown on scans to have grown, and whose tumor has a T790M gene mutation.
• People whose general health and ability to carry out daily activities is rated at a good level (a score of 0 or 1 on a standard medical scale), with no recent decline in the past two weeks, and who are expected to live at least 12 weeks.
• People who have at least one area of cancer that can be measured or assessed on scans (CT or MRI), and that has not previously been treated with radiation.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning at an acceptable level (confirm specific values with the trial site).
• Women of childbearing potential who have a negative pregnancy test within 72 hours before starting the study treatment, are not breastfeeding, and agree to use highly effective contraception from the start of the study until three months after the last dose.
• Men who agree to use highly effective contraception from the start of the study until three months after the last dose.
• People who are able to understand and agree to the trial requirements and sign a consent form.

Who may not be able to join:

• People who still have side effects from previous cancer treatment that are more than mild (except for hair loss or certain nerve-related effects from prior platinum chemotherapy).
• People with a history of another cancer in the past five years, unless it was fully treated with very low risk of returning (some exceptions may apply — confirm with trial site).
• People with cancer that has spread to the spine or brain, unless it is stable, causing no symptoms, and has not required steroid medication for at least four weeks.
• People with serious uncontrolled health conditions such as very high blood pressure, active bleeding in the past two weeks, an active infection (such as hepatitis B, hepatitis C, or HIV), or other conditions the doctor considers unsafe for participation.
• People with certain heart problems, including an abnormal heart rhythm measurement on an ECG, a history of heart failure or a heart condition that affects the electrical system of the heart, or a weakened heart pump function below a certain level (confirm specific values with trial site).
• People with a history of a lung condition called interstitial lung disease (ILD), or lung inflammation caused by radiation that required steroid treatment, or any currently active ILD.
• People who have ongoing severe nausea or vomiting, difficulty swallowing tablets, or significant stomach or bowel problems that could affect how the body absorbs the study medication.
• People with any other illness or condition that the doctor believes could make participation unsafe or interfere with the study.
• People who have a known allergy or sensitivity to the study drug or any of its ingredients.
• People who received an earlier-generation EGFR-targeted therapy (first or second generation) too recently before the trial start date (confirm timing with trial site).
• People who have previously received a third-generation EGFR-targeted therapy (such as osimertinib).
• People who received other chemotherapy, cancer drugs, or drugs from another clinical trial too recently before the trial start (confirm timing with trial site).
• People who have taken certain medications known to strongly interact with the study drug too recently before the trial start (confirm specific medications and timing with trial site).
• People who had major surgery within four weeks before the trial start.
• People who received radiation therapy too recently before the trial start, particularly if it covered a large area of the body (confirm timing with trial site).
• People who took part in another clinical trial or received an experimental drug within 28 days or five half-lives (whichever is longer) before the screening visit.
• People who, in the doctor's judgment, are unlikely to be able to follow the study requirements.

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