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 are willing and able to give your agreement to take part before any study procedures begin.
• You are between 18 and 75 years old (inclusive).
• You have been confirmed, through a tissue or cell sample taken within the last 60 days, to have a type of lung cancer called lung adenocarcinoma.
• Your lung cancer is at a stage where surgery to remove it is possible (Stage II to IIIB with certain lymph node involvement, based on standard cancer staging guidelines).
• Your cancer has a specific gene change called an ALK fusion mutation, confirmed by a recommended test.
• You have at least one tumor that can be clearly measured on a CT scan (at least 10 mm in size, or a lymph node at least 15 mm in size).
• You are generally able to carry out everyday activities with little to no limitation (as scored by a standard medical scale called ECOG 0–1).
• Your blood counts, liver function, and kidney function are within acceptable ranges as measured by blood tests (confirm specific values with trial site).
• Your heart and lung health are good enough to safely undergo surgery, based on tests such as an ECG, heart scan, and breathing tests.
• If you are a woman who could become pregnant, you must use highly effective contraception, have a negative pregnancy test, and not be breastfeeding when starting the study — or you must be confirmed as not able to become pregnant (e.g., postmenopausal or surgically sterilised).
• If you are a man whose partner could become pregnant, you must agree to use effective contraception during the study and for 3 months after your last dose.

Who may not be able to join:

• Your lung cancer includes certain other types of cancer cells, such as squamous cell, large cell neuroendocrine, or small cell components.
• You have already received any cancer treatment before joining the study.
• You are pregnant or currently breastfeeding.
• You are taking, or cannot stop taking at least 3 weeks before the study drug starts, certain medicines or herbal supplements that strongly affect how the body breaks down the study drug (confirm specific substances with trial site).
• You have a severe or uncontrolled health condition — such as very high blood pressure, active bleeding, or an active infection including hepatitis B, hepatitis C, or HIV — that could make participation unsafe.
• You have a history of a type of lung inflammation called interstitial lung disease (ILD), or have been treated with steroids for lung inflammation caused by radiation, or currently show signs of this condition.
• You have had a serious allergic reaction to the study drug (Ensartinib) or similar medicines, or you have ongoing severe nausea, vomiting, gut problems, difficulty swallowing, or have had major bowel surgery that could prevent the drug from being absorbed properly.
• You are unable to tolerate chemotherapy or you do not wish to receive chemotherapy.
• You have certain heart rhythm or electrical problems, including a prolonged QT interval on an ECG, serious abnormalities in heart rhythm, heart failure, or a personal or family history of certain inherited heart conditions (confirm specific details with trial site).
• You have a diagnosed neurological or psychiatric condition such as epilepsy or dementia.
• The trial doctors decide for any other reason that joining the trial would not be right for you.

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