Phase 3 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 have given written consent to take part in the study.
• People who have been diagnosed with non-small cell lung cancer (NSCLC), confirmed through a tissue or cell sample.
• People whose cancer is at an advanced stage (stage III or IV), including cases where the cancer has spread to the brain, or whose cancer has come back and cannot be treated with the aim of a cure.
• People whose cancer can be measured using standard imaging assessment methods.
• People of any physical fitness or activity level.
• People aged 18 or older, with no upper age limit.
• People whose tumour has a specific gene change (EGFR mutation) that is expected to respond to a type of targeted treatment called an EGFR TKI — this can be detected from tumour tissue or, if tissue is not available, from a blood test measuring tumour DNA.
• People who have not previously been treated with TKI (targeted therapy) medications.
• People who have a negative pregnancy test (blood or urine).
• People who are able to have children and are willing to use an effective form of contraception (such as an intrauterine device, blocked fallopian tubes, vasectomy, or complete abstinence) during treatment and for the first 4 months after treatment ends. Note: hormonal contraception alone may not be sufficient, as the study drugs may reduce its effectiveness.

Who may not be able to join:

• People whose overall health condition is not compatible with the study treatment or procedures.
• People who currently have another active cancer (other than NSCLC) that has the potential to spread and has not been fully treated.
• People already enrolled in another clinical trial that may conflict with this study, for example due to possible interactions between drugs (as determined by the treating doctor).
• People currently taking St John's Wort (hypericum perforatum) — this must be stopped before starting the study.
• People taking certain other medications that are known to interact with the study drugs and cannot be safely stopped, swapped, or managed. This includes, but is not limited to:
  • Medications that strongly affect how the body processes osimertinib (one of the study drugs).
  • Certain medications that strongly affect how the body processes afatinib (another study drug).
  • Proton pump inhibitors (medicines for stomach acid) or medications processed by a specific liver enzyme (CYP2D6) that interact with dacomitinib (the third study drug).
• People with serious or poorly controlled other illnesses that, in the treating doctor's opinion, would make participation unsafe or difficult.
• People with stomach or bowel conditions that would prevent them from swallowing tablets or absorbing the study medication properly.
• People who are pregnant or who refuse to use contraception as required by the study.
• People with abnormal blood test results that the treating doctor considers incompatible with the study drugs.
• People with a known allergy or sensitivity to any of the study drugs or similar medications.
• People with severely reduced liver or kidney function that the treating doctor considers incompatible with the study drugs.
• People with rare inherited conditions affecting how the body handles certain sugars, including galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
• People with a hereditary heart condition called congenital long QT syndrome.
• People who, in the treating doctor's judgement, should not take part — for example, if they are unlikely to be able to follow the study's requirements.

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