NCT03434418

Who might be able to join this trial:

• Your lung cancer tumor has been tested in a certified lab and found to have one of these specific genetic changes: EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q (having more than one mutation is allowed, as long as one of these is included).
• You have been diagnosed with Stage 4 non-small cell lung cancer (NSCLC), confirmed by a tissue or cell sample.
• Your cancer can be measured on a scan using standard guidelines.
• Your recent blood tests (taken within 14 days of starting the study) show your blood counts, liver function, and kidney function are within acceptable ranges (confirm specific numbers with trial site).
• Your heart's electrical activity (measured by an ECG) shows a normal reading within certain limits for your sex.
• Your heart is pumping effectively, with a function level of at least 45%.
• You are able to carry out normal daily activities with little or no limitation (confirm with trial site).
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 7 days of starting treatment and agree to use highly effective contraception; or you can show you cannot become pregnant (e.g., through menopause or surgical sterilisation, but not tubal ligation).
• If you are a man, you are willing to use barrier contraception (such as condoms) during the trial.
• You are 18 years of age or older.
• You are willing and able to sign a consent form before any study procedures begin.

Who may not be able to join:

• You have previously been treated with a type of drug called an EGFR TKI (a targeted therapy for this type of lung cancer).
• You have already received more than 2 rounds of systemic treatment for your advanced lung cancer.
• You have had chemotherapy or other cancer treatments within the last 14 days before starting the study drug.
• You have taken another experimental drug recently (within 5 half-lives of that drug — confirm timing with trial site).
• You have had another active cancer within the last 2 years, with the exception of certain skin cancers or early-stage cervical changes; and you must not currently be receiving treatment (such as hormonal therapy) for any previous cancer.
• You have had radiation therapy within the last 14 days.
• You have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not been treated; treated brain metastases may be allowed if it has been more than 14 days since radiotherapy ended and your condition is stable.
• You have serious problems absorbing medication through your digestive system, ongoing nausea and vomiting, chronic gut conditions, difficulty swallowing, or have had major bowel surgery that could prevent the study drug from being absorbed properly.
• Your tumor also has certain other specific EGFR genetic changes (T790M, exon 19 deletion, L858R, or exon 20 insertion), even if found alongside the qualifying mutations.
• You are currently pregnant or breastfeeding, as the effects of the study drug on an unborn baby or nursing infant are unknown.
• You have moderate or severe eye problems such as blurred vision, eye inflammation, corneal ulcers, very dry eyes, or a specific eye condition called keratitis (confirm grading with trial site).

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