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 understand what the trial involves and have signed and dated a consent form agreeing to take part.
• People aged 18 or older.
• People who have been diagnosed with locally advanced or spreading non-small cell lung cancer, confirmed by tissue or cell testing, and who have not yet had any systemic (whole-body) treatment for it.
• People whose cancer has specific gene changes (called EGFR mutations — including exon 19 deletions, exon 21 L858R, or T790M mutations) along with at least one additional gene change (such as in TP53, PIK3CA, CTNB1, or RB1), as confirmed by an accredited laboratory.
• People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People whose doctors estimate they are likely to live for at least 12 weeks.
• People with adequate bone marrow, liver, kidney, and other organ function as assessed by the trial team.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People who have brain metastases (cancer that has spread to the brain) that are considered stable may be eligible (confirm with trial site).

Who may not be able to join:

• People who have already received systemic (whole-body) treatment for locally advanced or metastatic disease.
• People who have received certain targeted treatments (such as EGFR or VEGFR antibody therapies) within the 4 weeks before starting the trial.
• People who have received radiation therapy within 14 days before starting the trial, or who have not yet recovered from side effects of radiation — though some specific types of radiotherapy may be allowed if completed at least 7 days before starting (confirm with trial site).
• People who are currently taking, or cannot stop taking, certain medications or herbal supplements that strongly affect how the body processes drugs (specifically CYP1A2 or CYP3A inhibitors or inducers) within 1–2 weeks before starting the trial.
• People who have cancer that has spread to compress the spinal cord, or has spread to the lining of the brain.
• People who have been diagnosed with another cancer within the past 2 years.
• People who still have significant side effects (worse than mild, except for hair loss) from previous cancer treatments such as chemotherapy or radiotherapy.
• People who have had a stroke or bleeding in the brain within the 6 months before starting the trial.
• People with severe or poorly controlled ongoing health conditions, including poorly controlled high blood pressure or active bleeding.
• People with ongoing or active infections, including hepatitis B, hepatitis C, HIV, or COVID-19.
• People with certain heart-related conditions or abnormalities (confirm with trial site for details).
• People with a history of certain types of lung inflammation or scarring (interstitial lung disease, radiation pneumonitis requiring steroid treatment, or immune-related lung inflammation from previous immunotherapy).
• People who have ongoing severe nausea or vomiting, a chronic gut condition, difficulty swallowing, or a bowel removal that prevents proper absorption of the trial medications.
• 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 trial drugs or their ingredients.
• People whom the trial doctors consider unsuitable for any other reason.

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