Early Phase 1 Lung Cancer Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing to take part voluntarily, have signed a consent form, and are able to attend follow-up visits as required.
- People aged between 18 and 75 years old (inclusive).
- People with a performance status score of 0–2 on the ECOG scale, which is a measure of how much a health condition affects daily activities (confirm with trial site).
- People whose life expectancy is at least 3 months.
- People who have at least one measurable area of cancer located outside the brain, as assessed using standard imaging criteria (RECIST 1.1).
- People diagnosed with non-small cell lung cancer, confirmed by a tissue or cell sample.
- People who do not have cancer that has spread to the membranes surrounding the brain or spinal cord (leptomeningeal metastasis), as assessed using EANO criteria.
- People whose tumour tissue or blood sample has confirmed a specific type of genetic change in the EGFR gene (either an exon 19 deletion or the L858R mutation), which makes the cancer sensitive to certain targeted treatments.
- People who have not yet received any systemic cancer treatment and are planned to start first-line treatment with one of three specific targeted therapy medicines: osimertinib, aumolertinib, or furmonertinib.
- People whose major organ functions are within acceptable ranges, including: haemoglobin at least 90 g/L; neutrophil count at least 1.5×10⁹/L; platelet count at least 80×10⁹/L; bilirubin below 1.5 times the upper limit of normal; liver enzymes (ALT and AST) below 2.5 times the upper limit of normal; and kidney function within acceptable limits based on blood or calculated measures.
- Women of childbearing age who have had a negative pregnancy test (blood or urine) within 7 days before joining and who agree to use reliable contraception during the trial and for 8 weeks after the last dose.
- Men who agree to use reliable contraception during the trial and for 8 weeks after the last dose, or who have had a surgical sterilisation procedure.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have previously taken any EGFR tyrosine kinase inhibitor (a type of targeted cancer medicine that works on the EGFR pathway).
- People who have previously received chemotherapy for lung cancer.
- People who have previously received radiotherapy for lung cancer, except for palliative radiotherapy directed at bone metastases.
- People who have had major surgery within 4 weeks before the first dose of the study medication.
- People who have used strong inhibitors or inducers of a liver enzyme called CYP3A4 within 7 days before the first dose (these are certain medicines or substances that affect how other drugs are broken down in the body — confirm with trial site).
- People who currently have another active cancer, except for certain low-risk skin cancers (basal cell carcinoma) or in situ cancer (very early-stage cancer that has not spread).
- People who have uncontrollable fluid build-up around the lungs or around the heart.
- People who are allergic to the contrast dye used in CT or MRI scans, or who cannot undergo MRI examinations.
- People who, in the investigator's judgement, have serious or poorly controlled conditions such as uncontrolled high blood pressure, an active tendency to bleed, or an active infection.
- People with significant digestive system problems that could affect their ability to take or absorb oral medication, such as being unable to swallow tablets, uncontrollable nausea or vomiting, a history of extensive bowel removal surgery, ongoing diarrhea, atrophic gastritis, stomach conditions requiring long-term use of proton pump inhibitors that have not been resolved, Crohn's disease, or ulcerative colitis.
- People with liver-related conditions including hepatic encephalopathy (a decline in brain function due to liver disease), hepatorenal syndrome (kidney failure related to liver disease), or liver cirrhosis.
- People whose heart test results meet any of the following: an average corrected heart rhythm interval (QTcF) greater than 470 milliseconds on resting ECG; certain abnormalities in the electrical patterns or conduction of the heart seen on ECG (such as complete left bundle branch block, third-degree or second-degree heart block, or a PR interval greater than 250 milliseconds); any factors that increase the risk of dangerous heart rhythms, such as heart failure, low potassium levels, congenital long QT syndrome, a family history of long QT syndrome, or a family history of unexplained sudden death in close relatives under 40 years old; or a heart pumping function (left ventricular ejection fraction) below 50%.
- People whose blood test results show insufficient bone marrow or organ function, including: neutrophil count below 1.5×10⁹/L; platelet count below 100×10⁹/L; haemoglobin below 90 g/L; liver enzyme levels (ALT or AST) above 3 times the upper limit of normal (or above 5 times if liver metastasis is present); total bilirubin above 1.5 times the upper limit of normal (or above 3 times in certain liver conditions or liver metastasis); creatinine above 1.5 times the upper limit of normal combined with a kidney filtration rate below 50 mL/min; or blood albumin below 28 g/L.
- People with an active fungal, bacterial, or viral infection that requires systemic treatment (medicine taken throughout the body).
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- People with a history of interstitial lung disease, drug-induced interstitial lung disease, radiation-related lung inflammation that required steroid treatment, or any signs of currently active interstitial lung disease.
- People who, in the investigator's judgement, are unlikely to follow the study procedures, such as those with a known history of significant neurological or psychiatric conditions, or who are currently experiencing a psychiatric disorder.
- People who, in the investigator's judgement, have any condition that could put their safety at risk or affect the reliability of the study results.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Lin Chuyang, Director, Nanchang University
Phone: +86 13699549060
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Overall Survival（OS）
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.