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 have been confirmed by tissue or cell testing to have locally advanced, returning, or spread-to-other-areas non-small cell lung cancer (NSCLC) that is not suitable for standard curative treatment. Small cell lung cancer and mixed types are not included.
• People whose cancer has continued to grow or spread after at least one prior systemic (whole-body) cancer treatment, or people for whom standard treatments are not available, not tolerated, or not considered appropriate. (Note: people being considered for specific groups within the trial — Group F and Group H — must not have had any prior systemic treatment for their advanced or metastatic disease; confirm with trial site.)
• People who have tumor tissue stored from a previous biopsy available for testing (ideally taken after the last targeted treatment and no older than 6 months), or who are able to have a new biopsy taken if it can be done safely.
• People who have at least one area of measurable disease that can be clearly seen and tracked on CT or MRI scans, and that was not biopsied during the screening period. Areas that were previously treated with radiation must have shown signs of regrowth to count as measurable.
• People whose tumor has been confirmed through accredited laboratory testing to carry a specific gene change (mutation) in the EGFR and/or HER2 genes known to drive the cancer.
• People who have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People with a life expectancy of at least 12 weeks.
• People whose blood tests, taken within 7 days before the first dose, show that bone marrow is working adequately — specifically: haemoglobin of at least 9.0 g/dL (without recent blood transfusions or certain medicines), platelets of at least 100 × 10⁹ cells/L, and neutrophils (a type of white blood cell) of at least 1.5 × 10⁹ cells/L (without use of certain growth-stimulating medicines).
• People whose kidney function tests, taken within 7 days before the first dose, show a kidney filtration rate above 50 mL/min per 1.73 m².
• People whose liver function tests, taken within 7 days before the first dose, fall within acceptable ranges for bilirubin and liver enzymes (with slightly higher limits allowed for people with certain documented liver conditions or liver involvement from the cancer).

Who may not be able to join:

• People who have received a specific type of cancer drug called an EGFR tyrosine kinase inhibitor (TKI) within a short period before the first dose of the study drug (the exact timeframe depends on the specific drug; confirm with trial site).
• People who have received other systemic (whole-body) cancer treatments within 14 days before the first study dose.
• People who have had radiation therapy, including targeted brain radiation or palliative radiation, within 14 days before the first study dose.
• People who have received immunotherapy within 28 days before the first study dose.
• People who still have unresolved side effects rated as moderate or severe (Grade 2 or higher) from previous cancer treatments, with the exception of hair loss and skin colour changes. People with ongoing but stable Grade 2 side effects may still be considered after discussion between the treating doctor and the trial sponsor.
• People with a history of cancer originating in the brain or the lining around the brain, or who have brain metastases (cancer that has spread to the brain) that are causing symptoms or require treatment such as radiation or surgery. (There are specific exceptions to this rule for certain groups within the trial; confirm details with the trial site.)
• People with a history of spinal cord compression, unless the compression was treated more than 3 months ago, there are no current symptoms, and imaging shows the area is stable. (Exceptions also apply for specific trial groups; confirm with trial site.)
• People with a history of significant heart failure (rated Class II or higher on a standard heart health scale), serious heart rhythm problems requiring treatment, or certain other heart abnormalities detected on an ECG.
• People with known HIV infection, unless specific conditions are met — including stable virus levels, being on established HIV treatment for at least 4 weeks, and no serious infections in the past 12 months (eligibility to be determined by the treating doctor).
• People with active Hepatitis B infection confirmed by specific blood tests.
• People with active Hepatitis C infection confirmed by specific blood tests. (People with a history of chronic Hepatitis B or C that is well controlled with treatment may still be considered at the treating doctor's discretion.)
• People who have used certain medications that strongly affect how the body processes a liver enzyme called CYP3A4 within 14 days before the first study dose (confirm with trial site which medications are included).

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