Phase 1 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:

• Adults aged 18 or older
• People who have been diagnosed with non-small cell lung cancer (a type of lung cancer) that has spread to other parts of the body, confirmed by a pathology report
• People whose tumor has a specific genetic change (mutation) in a gene called EGFR — specifically a deletion in exon 19 or a change called L858R — confirmed by a tumor tissue biopsy test at an approved laboratory
• People whose tumor has certain less common EGFR gene changes (such as G719X, S768I, or L861Q), as long as one of the common mutations listed above is also present
• People whose tumor also has an additional mutation called T790M
• People whose cancer has at least one measurable tumor, as defined by standard medical measurement guidelines
• People who are reasonably active and able to carry out basic daily activities (a doctor will assess this using a standard scale)
• People who are able to swallow pills
• People with a life expectancy of more than 3 months
• People whose blood test results show that their white blood cells, platelets, red blood cells, liver function, and kidney function are all within acceptable ranges (the trial site will check these)
• People who have hepatitis B but whose virus levels are undetectable while on suppressive treatment
• People who have had hepatitis C, as long as it has been treated and the virus is no longer detectable
• People who have had treatment for cancer that has spread to the brain, as long as those brain metastases are not currently causing symptoms and no ongoing treatment is needed
• People with newly found or growing brain metastases or cancer affecting the lining of the brain and spinal cord, if the treating doctor determines that immediate brain-specific treatment is not needed during the first treatment cycle — being on a stable dose of a steroid medication called decadron is permitted
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial
• People with a known heart condition history who have been assessed using a standard heart function scale and are rated at class 2B or better (the trial site will assess this)
• People who are able to understand and sign a written consent form

Who may not be able to join:

• People who have previously been treated with a type of drug called an EGFR tyrosine kinase inhibitor (a targeted therapy for EGFR-related lung cancer)
• People who are still experiencing side effects (above a mild level) from a previous cancer treatment, except for hair loss
• People with a history of a lung condition called interstitial lung disease, lung inflammation caused by radiation treatment that required steroids, or any currently active interstitial lung disease
• People currently taking part in another clinical trial or receiving immunotherapy, within a certain time window before this trial begins
• People with a serious illness that is not currently under control
• People with mental health conditions or personal circumstances that would make it difficult to follow the trial's requirements
• People who have had a serious allergic reaction to drugs chemically similar to the two study drugs (BC2059 or AZD9291), or who are allergic to any inactive ingredients in those drugs
• People currently taking, or unable to stop taking, certain medications or herbal supplements that strongly affect how the body processes the study drug (these are substances that strongly activate a liver enzyme called CYP3A4) — the trial site will advise on specific drugs and washout periods
• People who are pregnant, as one of the study drugs may harm an unborn baby
• People who are breastfeeding
• People with a significant recent history of heart-related events such as a heart attack or a blood clot in the last 6 months
• People with certain heart rhythm or electrical problems detected on a heart tracing (ECG), including an abnormally long QT interval, irregular heart rhythm, or a weak pumping function of the heart (the trial site will assess this)
• People who have another active cancer other than the lung cancer being studied — exceptions may apply for certain low-risk or treated skin cancers, a non-invasive breast condition called DCIS, or certain slow-growing cancers currently being monitored
• People with severe uncontrolled conditions such as very high blood pressure, active uncontrolled bleeding, or active HIV infection
• People who may have difficulty absorbing oral (swallowed) medication due to conditions such as severe nausea and vomiting, certain digestive diseases, or a history of major bowel surgery
• People who the trial doctor believes are unlikely to follow the trial's procedures and requirements
• People who were involved in planning or running this trial

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