Phase 3 Lung Cancer Trial, By Invitation

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:

• Adults aged 18 or older, of any gender.
• People who have been confirmed through laboratory testing (biopsy or cell sample) to have locally advanced or metastatic non-small cell lung cancer (NSCLC), including those with cancer that has come back after surgery, or those newly diagnosed with Stage IIIb, IIIc, or IV NSCLC.
• People who have not previously received systemic cancer treatments such as chemotherapy, targeted therapy, or immunotherapy — or, if they did receive treatment before surgery or after surgery, their cancer must have returned at least 6 months after finishing that earlier treatment.
• People whose tumour has been confirmed to carry a specific gene change (EGFR mutation) — either an exon 19 deletion or an L858R mutation — that makes it sensitive to a class of drugs called EGFR-TKIs.
• People who have at least one tumour that can be measured on a scan (CT or MRI), with the longest measurement being at least 10 mm (or at least 15 mm across the short side for lymph nodes), and which has not been recently treated with radiotherapy or biopsy during screening (confirm with trial site if a biopsy was needed to confirm the gene status).
• People who are generally well enough to carry out daily activities with little or no limitation, based on a standard medical scoring scale called ECOG, with a score of 0 or 1.
• People who are expected to live for at least 3 months.
• Women who could become pregnant must have a negative blood pregnancy test before joining. People of reproductive potential must agree to avoid pregnancy by abstaining from sex or using effective contraception during the trial and for at least 3 months after the last dose.
• People who are able to understand what the trial involves, follow the study requirements, attend required visits, and sign a written consent form agreeing to take part voluntarily.

Who may not be able to join:

• People who have had major surgery within 28 days before the first dose of the study drug (confirm with trial site what counts as "major surgery" in this context).
• People who have received local or palliative radiotherapy (e.g., for bone spread) within 14 days before the first dose.
• People who have taken certain medications that strongly interact with a liver enzyme called CYP3A4 within 7 days before the first dose, or who would need to continue taking them during the trial.
• People who have used Chinese herbal medicines or traditional Chinese medicine preparations for cancer treatment within 7 days before the first dose, or who would need to continue using them.
• People who are currently taking medications known to affect heart rhythm in a specific way (prolonging the QTc interval) and would need to continue these during the trial.
• 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 or a specific type of nerve-related side effect from platinum-based chemotherapy.
• People with spinal cord compression, or with brain metastases that are causing symptoms, are unstable, or have required steroid treatment within the past 4 weeks. People with brain metastases who received radiotherapy must have had stable symptoms for at least 28 days after finishing that radiotherapy.
• People with severe or poorly controlled conditions such as high blood pressure not managed by medication, or active bleeding disorders, that in the opinion of the trial doctor could interfere with participation.
• People with active infections requiring treatment, including active hepatitis B, hepatitis C, HIV, syphilis, or other serious infections (specific blood test thresholds apply — confirm with trial site).
• People with significant digestive system problems that could affect how the study drug is absorbed, such as being unable to swallow tablets, uncontrolled nausea or vomiting, a history of large portions of the digestive tract being removed, ongoing diarrhoea, or conditions like Crohn's disease or ulcerative colitis requiring long-term use of certain stomach acid medications.
• People with a heart rhythm measurement (QTcF interval) that is too long — above 450 ms for males or 470 ms for females — or who have significant heart rhythm problems, certain types of heart block, a recent heart attack within the past 6 months, or other specific heart abnormalities on a resting ECG.
• People with risk factors for heart rhythm problems, such as heart failure, low potassium levels, an inherited heart condition called long QT syndrome, a family history of sudden cardiac death before age 40, or use of drugs that may affect heart rhythm.
• People whose heart pumping function (left ventricular ejection fraction) is 50% or below.
• People with a history of a specific type of lung inflammation called interstitial lung disease (ILD), including drug-related ILD, radiation-related lung inflammation that required steroid treatment, or currently active ILD.
• People whose blood test results show that bone marrow or organ function does not meet the required levels — including low white blood cell counts, low platelets, low haemoglobin, abnormal liver function, or reduced kidney function (specific laboratory thresholds apply — confirm with trial site).
• People with a known allergy or sensitivity to the study drug or similar medications.
• Women who are currently breastfeeding.
• People with a history of another cancer in the past 5 years, except for certain cancers considered fully cured, such as cervical carcinoma in situ, basal cell skin cancer, squamous cell skin cancer, or papillary thyroid cancer.
• People with a serious or uncontrolled eye condition that the trial doctor considers may increase the risk of taking the study drug.

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