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:

• People who are able to give written, documented consent to participate.
• People aged 18 or older.
• People who have been diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body and cannot be treated with the aim of a cure.
• People who have a confirmed EGFR gene mutation (a specific change in a gene linked to their cancer) shown by a certified laboratory — with different mutation types required depending on which part of the trial a person is being considered for (confirm with trial site).
• People who are able to provide tumour tissue samples and blood samples taken at specific timepoints, depending on which part of the trial applies (confirm with trial site).
• People who have previously received certain cancer treatments, depending on which group of the trial they are being considered for — some groups require prior treatment with a third-generation EGFR-targeting drug (such as osimertinib), while one group requires no prior systemic cancer treatment (confirm with trial site).
• People who have a good general level of physical functioning (able to carry out normal daily activities with at most minor limitations) and a life expectancy of at least 12 weeks.
• People whose cancer has spread to the brain only if that spread is considered stable at the time of joining.
• People who have at least one measurable area of cancer that can be tracked on scans according to standard criteria.
• People whose blood counts and organ function (such as liver and kidneys) are at adequate levels.

Who may not be able to join:

• People whose lung cancer has features of a different type of lung cancer called small-cell lung cancer (SCLC), or whose cancer has changed into that type.
• People in Part A of the trial whose only EGFR mutation is a specific type called exon 20 insertion (people with this mutation alongside other EGFR mutations may still be considered — confirm with trial site).
• People who have previously received two or more courses of third-generation EGFR-targeting treatment.
• People in the treatment-naïve group (B3) who have already received systemic cancer treatment for advanced disease.
• People who have received immunotherapy or antibody-based cancer treatments within 4 weeks before starting the trial.
• People who have received chemotherapy, other anticancer drugs, or drugs from another clinical trial within 14 days before starting.
• People who have received certain types of radiotherapy within 7 to 28 days before starting, depending on the extent of radiation (confirm with trial site).
• People who are currently taking, or are unable to stop taking, certain medications or herbal supplements that strongly affect how the body processes drugs (known as CYP3A4 inhibitors or inducers), unless a sufficient period without those drugs has passed.
• People who are currently taking, or are unable to stop taking, certain medications that are processed by the same pathway and have a narrow safe dosage range (CYP3A4 sensitive substrates with a narrow therapeutic index), unless a sufficient washout period has passed.
• People who are currently taking, or are unable to stop taking, proton pump inhibitor medications (commonly used for acid reflux or stomach protection), unless at least one week without them has passed.
• People who have had major surgery within 4 weeks before starting, or who are expected to need major surgery during the trial.
• People who still have side effects from previous cancer treatment that have not resolved to a mild level.
• People who have compression of the spinal cord or cancer that has spread to the membranes surrounding the brain and spinal cord.
• People who have had another type of cancer within the past 2 years.
• People with severe or uncontrolled health conditions, including uncontrolled high blood pressure or active uncontrolled bleeding, as assessed by the trial doctor.
• People with an active infection, including hepatitis B, hepatitis C, or HIV.
• People with certain heart rhythm or electrical conduction abnormalities, or a specific heart measurement (QTcF) above 470 milliseconds on a resting heart tracing.
• People who have a history of, or currently have, a lung condition called interstitial lung disease (ILD).
• People with conditions that would prevent the study drug from being properly absorbed by the body.
• People who have received a live vaccine within 2 weeks before starting the trial.
• People who are pregnant or breastfeeding.
• People who have a known allergy or sensitivity to the ingredients in the study drugs being used in the relevant part of the trial.

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