Phase 2 Rare Disease 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 18 years old or older (male or female)
• You have been diagnosed with non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body, confirmed by a tissue or cell sample test
• You have received no more than one previous round of chemotherapy for this cancer
• Your tumor has been tested and found to have a specific uncommon gene change (mutation) in the EGFR gene — specifically one or more of: L861Q, G719X, or S768I — and no other EGFR or similar gene changes
• You have at least one area of cancer that can be measured on a scan
• Your general health and ability to carry out daily activities is at an acceptable level (confirm with trial site)
• Doctors estimate you have a life expectancy of more than 3 months
• Your blood counts and liver, kidney, and clotting functions are at acceptable levels
• If you are able to have children, you are willing to use an approved form of contraception during the trial

Who may not be able to join:

• You have previously taken a type of targeted drug called an EGFR-TKI (a specific class of cancer treatment)
• You have had chemotherapy, immunotherapy, radiation therapy, or certain traditional medicines for cancer within the past 2 to 4 weeks before joining
• You have taken certain medicines or foods that strongly affect how the body processes drugs (a specific liver enzyme called CYP3A4) within roughly the past 2 weeks or longer (confirm with trial site)
• You have had major surgery or a serious injury within the past 4 weeks
• You still have significant side effects (above a mild level) from a previous cancer treatment, apart from hair loss
• You are unable to swallow tablets, or have a serious gut condition that affects how your body absorbs medicine
• Your cancer has spread to the brain and is currently active
• You have certain lung conditions, such as interstitial lung disease, radiation-related lung inflammation requiring steroids, drug-related lung inflammation, or a large uncontrolled build-up of fluid around the lungs or heart
• You currently have an active infection that has not been treated or controlled
• You have a serious heart condition
• You have another serious long-term illness that makes taking part in a trial unsuitable
• You have taken part in another clinical trial within the past 4 weeks or within a certain timeframe from your last trial dose (confirm with trial site)
• You have a known dependence on alcohol or drugs
• You have a mental health condition or difficulty following medical instructions
• You have previously had an organ transplant or a stem cell transplant
• You are pregnant or breastfeeding
• You have a known allergy to any ingredient in the trial medicine
• You have had another type of cancer within the past 3 years (some low-risk cancers may be excepted — confirm with trial site)

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