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 aged 18 or older
• People who have been diagnosed with advanced (stage IIIB or IV) non-small cell lung cancer (NSCLC), confirmed through a tissue sample
• People whose tumour has a specific type of gene change (mutation) in the EGFR gene, known as Ex19del or L858R, confirmed by a local test
• People who are either about to start treatment with osimertinib 80mg daily as their standard cancer treatment, or have already been taking it for no more than 28 days
• People who have had a chest and abdominal CT or MRI scan within the 42 days before starting osimertinib
• People who have not previously received any systemic (whole-body) treatment for their advanced or metastatic cancer, other than osimertinib for up to 28 days as noted above
• People who have at least one measurable area of disease visible on scans, according to standard measurement criteria
• Women who could potentially become pregnant must be using highly effective contraception, have a negative pregnancy test within 7 days before starting treatment, and must not be breastfeeding
• Women who cannot become pregnant must be able to demonstrate this through menopause (confirm with trial site for specific age and hormonal criteria) or through documented surgical procedures such as removal of the uterus, both ovaries, or both fallopian tubes (tubal ligation does not qualify)
• People who, after 21 to 28 days of taking osimertinib, still have detectable signs of the EGFR mutation in a blood test (liquid biopsy) processed at the trial's central laboratory — this is assessed during the pre-screening phase
• People with an ECOG performance status of 0 to 2, meaning they are able to carry out at least some daily activities independently (confirm with trial site)
• People who are willing and able to attend hospital visits for treatment and follow-up for the full duration of the study
• People who began osimertinib no more than 10 weeks before the chemotherapy phase of the trial starts

Who may not be able to join:

• People with a history of another primary cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 6 months, and carries a low risk of coming back — or unless it was a certain type of treated skin cancer or pre-cancerous condition with no current evidence of disease
• People who have had cancer spread to the membranes lining the brain and spinal cord (leptomeningeal carcinomatosis)
• People currently enrolled in another interventional clinical trial (participation in non-interventional or observational studies may be acceptable)
• People who have previously been enrolled in this same trial
• People with brain metastases that are causing active symptoms (people with brain metastases that are not causing symptoms may still be considered)
• People currently taking, or unable to stop taking before the first dose, certain medications or herbal supplements that strongly affect how the body processes a liver enzyme called CYP3A4 (confirm with trial site for specific examples)
• People whose osimertinib dose had to be stopped or reduced due to side effects for more than 7 days, or who have ongoing unresolved side effects from osimertinib that would prevent participation
• People who have unresolved side effects from previous treatments that are graded above a mild level (above CTCAE grade 1), except for hair loss or certain nerve-related side effects from prior platinum-based chemotherapy
• People with a known allergy or sensitivity to osimertinib or to any of the chemotherapy drugs used in the trial
• People with severe or uncontrolled health conditions such as uncontrolled high blood pressure, active uncontrolled bleeding, or active infections including hepatitis B, hepatitis C, or HIV
• People with ongoing nausea and vomiting that cannot be controlled, chronic digestive tract conditions, an inability to swallow tablets, or a history of significant bowel surgery that could affect how the body absorbs osimertinib
• People with certain heart-related concerns, including an abnormal heart rhythm measurement on an ECG (QTc above 470 milliseconds), certain specific heart conduction abnormalities, a personal or close family history of a condition called long QT syndrome, or low levels of potassium, magnesium, or calcium in the blood that cannot be corrected before the first dose (confirm with trial site)
• People with a history of a lung condition called interstitial lung disease, including cases caused by medication or radiation treatment requiring steroid therapy, or with currently active interstitial lung disease
• People whose blood test results show that their bone marrow or organ function is not adequate — this includes low white blood cell counts, low platelet counts, low haemoglobin levels, or abnormal liver or kidney function values (confirm with trial site for specific thresholds); these levels cannot be boosted using growth factors, transfusions, or similar supports to meet the criteria
• People with abnormal blood clotting results in the 7 days before chemotherapy, unless they are already on a prescribed anticoagulant (blood-thinning) medication
• People whom the trial investigator believes are unlikely to follow the study requirements
• Women who are pregnant or breastfeeding
• People of reproductive age who are not willing to use effective contraception — from the screening period until 4 months after the last dose of osimertinib (for men) or 6 weeks after the last dose of osimertinib (for women), and 6 months after the last dose of chemotherapy
• People who are unable to give informed consent because they cannot understand the nature and implications of the trial
• People who have taken another experimental drug within the previous 3 months or within five half-lives of that drug, whichever is longer
• People who have received chemotherapy, biological therapy, or hormonal cancer treatment within 6 months before the first dose of study treatment (hormonal therapy for non-cancer reasons, such as hormone replacement therapy, is acceptable)
• People who have had major surgery within 4 weeks before starting the study, or who have not yet fully recovered from a recent major surgery

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