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:

• People diagnosed with non-small cell lung cancer (NSCLC) that has been completely removed by surgery, at a specific stage (stage IB to IIIA), and whose tumour tests positive for an ALK gene fusion (confirmed by an approved lab test).
• Adults aged 18 to 75 years (male or female).
• People whose general physical health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2).
• People who have fully or largely recovered from surgery or any standard chemotherapy given after surgery, with only minor side effects remaining (hair loss or mild nerve-related side effects from platinum-based chemotherapy are acceptable).
• People whose pre-treatment medical checks show no signs that the cancer has come back.
• People who have enough tumour tissue samples available (from solid tissue, not fluid) for further laboratory testing.
• People whose blood test results meet specific minimum levels for red blood cells, white blood cells, and platelets (blood transfusions to reach these levels are permitted — confirm with trial site).
• People whose liver function blood tests are within an acceptable range.
• People whose kidney function tests are within an acceptable range.
• People (or their legal representative) who have signed a consent form agreeing to take part.
• People who are able to follow the study procedures and can swallow oral medication (tablets or capsules).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study treatment.
• People of reproductive age (all genders) must agree to use a reliable form of contraception from before joining the trial, throughout the study, and for at least 8 weeks after the last dose of the study treatment.

Who may not be able to join:

• People who have previously received targeted drug therapy (such as tyrosine kinase inhibitors or monoclonal antibodies) or any experimental treatment for their NSCLC.
• People who have previously had radiotherapy directed at the lung area affected by NSCLC.
• People with a known allergy to Ensatinib or any of its ingredients.
• People with a history of certain lung conditions, including interstitial lung disease, lung inflammation caused by drugs or radiation requiring steroid treatment, or any currently active lung tissue disease; or whose baseline scan shows a specific type of lung scarring (idiopathic pulmonary fibrosis).
• People with certain unstable or serious ongoing health conditions, including: active infection, uncontrolled high blood pressure, unstable chest pain (angina), a new episode of chest pain within the past 3 months, moderate-to-severe heart failure, a heart attack within the past 6 months, a serious irregular heartbeat requiring medication, or significant liver, kidney, or metabolic disease.
• Women who are pregnant or currently breastfeeding.
• People with a history of neurological or psychiatric conditions, including epilepsy or dementia.
• People whom the trial investigators determine are not suitable for the study for other medical reasons.

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