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 willing and able to give your agreement to take part before any study activities begin.
• You are a man or woman between 30 and 75 years old.
• You have been diagnosed with early-stage (Stage I) lung cancer (a type called adenocarcinoma) that has been confirmed by a lab test, and you also have at least one other area of concern (a hazy patch called a "ground glass" spot) in a different part of your lung that meets specific size and density requirements.
• Your lung cancer has a specific gene change (called an EGFR mutation — either "L858R" or "exon 19 deletion") found in the removed tumour.
• You are generally in good health and able to carry out daily activities without much difficulty, and your doctors expect you to live for at least 12 weeks.
• You have recovered well from your lung cancer surgery without major complications.
• If you are a woman who could become pregnant, you must use highly effective birth control, have a negative pregnancy test, and not be breastfeeding before starting the study treatment — OR you must be post-menopausal or have had a surgical procedure that means you cannot become pregnant (such as removal of both ovaries or the womb).
• If you are a man, you must be willing to use barrier contraception (such as condoms) during the study.

Who may not be able to join:

• You received any cancer treatment (such as chemotherapy, radiation, or other anti-cancer drugs) before or after surgery, prior to joining the trial.
• Your surgery involved removing more than one lobe of the lung, or an entire lung (confirm with trial site).
• You had serious lung complications (such as severe lung injury or pneumonia) during your recovery from surgery.
• You are currently taking, or cannot stop taking, certain medicines or herbal supplements that are known to interfere with how the study drug works in the body (confirm with trial site for the specific list).
• You have a serious uncontrolled illness, such as very high blood pressure that cannot be controlled, active uncontrolled bleeding, or an active infection such as hepatitis B, hepatitis C, or HIV.
• You have ongoing severe nausea or vomiting, a chronic gut condition, difficulty swallowing, or have had significant bowel surgery that might stop the study drug from being properly absorbed.
• You have certain heart problems, including an abnormal heart rhythm reading on an ECG, a heart condition that increases the risk of dangerous heart rhythm problems, or a personal or close family history of a condition called "long QT syndrome."
• You have a history of a lung condition called interstitial lung disease, or have previously had lung inflammation from medication or radiation that needed steroid treatment.
• Your blood test results show that your bone marrow, liver, or kidneys are not working well enough (confirm with trial site for specific values).
• You are currently breastfeeding.
• You are pregnant, have a positive pregnancy test, or are not using effective contraception if you are able to have children.
• You are directly involved in organising or running this clinical trial.
• The trial doctor feels, for any reason, that taking part would not be right for you.

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